Trial Outcomes & Findings for Pelvic Floor Repair Systems for Prolapse Repair (NCT NCT00638235)
NCT ID: NCT00638235
Last Updated: 2016-10-28
Results Overview
Analysis includes only subjects with posterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Recruitment status
COMPLETED
Target enrollment
725 participants
Primary outcome timeframe
12-months
Results posted on
2016-10-28
Participant Flow
Phases duration: Phase I: May 2006 - Oct 2009 Phase II: Feb 2007 - Jun 2010 Phase III/IV: Apr 2007 - May 2010 Phase V: Apr 2008 - Jan 2011 Phase VI: Oct 2008 - Mar 2010 Phase VII: Apr 2009 - Feb 2012
Only those subjects who meet all study criteria, provide written consent and are implanted with an AMS PFR System device for prolapse repair will be considered evaluable for analysis in the study
Participant milestones
| Measure |
Phase I (IntePro, US Only)
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, for Study Use Only, EU Only)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
141
|
26
|
81
|
56
|
55
|
139
|
23
|
35
|
142
|
|
Overall Study
COMPLETED
|
110
|
23
|
63
|
46
|
42
|
113
|
23
|
34
|
124
|
|
Overall Study
NOT COMPLETED
|
31
|
3
|
18
|
10
|
13
|
26
|
0
|
1
|
18
|
Reasons for withdrawal
| Measure |
Phase I (IntePro, US Only)
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, for Study Use Only, EU Only)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
31
|
3
|
18
|
10
|
13
|
26
|
0
|
1
|
18
|
Baseline Characteristics
Pelvic Floor Repair Systems for Prolapse Repair
Baseline characteristics by cohort
| Measure |
Phase I (IntePro, US Only)
n=141 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=26 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=81 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=56 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=55 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=139 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=35 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=142 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
Total
n=698 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 9.0 • n=7 Participants
|
69.7 years
STANDARD_DEVIATION 10.9 • n=5 Participants
|
63.4 years
STANDARD_DEVIATION 11.1 • n=4 Participants
|
63.3 years
STANDARD_DEVIATION 11.8 • n=21 Participants
|
62.5 years
STANDARD_DEVIATION 11.6 • n=8 Participants
|
63.4 years
STANDARD_DEVIATION 9.6 • n=8 Participants
|
65.4 years
STANDARD_DEVIATION 8.4 • n=24 Participants
|
63.9 years
STANDARD_DEVIATION 9.8 • n=42 Participants
|
NA years
STANDARD_DEVIATION 0 • n=42 Participants
|
|
Sex: Female, Male
Female
|
141 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
56 Participants
n=4 Participants
|
55 Participants
n=21 Participants
|
139 Participants
n=8 Participants
|
23 Participants
n=8 Participants
|
35 Participants
n=24 Participants
|
142 Participants
n=42 Participants
|
698 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
0 Participants
n=42 Participants
|
PRIMARY outcome
Timeframe: 12-monthsPopulation: Analysis conducted only for those subjects with posterior vaginal wall prolapse \>= stage II at baseline. Where a "zero" is indicated, no subjects meeting this criteria were enrolled.
Analysis includes only subjects with posterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=117 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=24 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=44 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=120 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent of Subjects With an ICS (International Incontinence Society) POP-Q (Pelvic Organ Prolapse Quantification System) Stage of </= Stage I in the Posterior Compartment at One Year Post Procedure
|
93.2 percentage of participant
Interval 87.0 to 97.0
|
100 percentage of participant
Interval 85.8 to 100.0
|
—
|
—
|
93.2 percentage of participant
Interval 81.3 to 98.6
|
92.5 percentage of participant
Interval 86.2 to 96.5
|
100 percentage of participant
Interval 85.2 to 100.0
|
—
|
—
|
PRIMARY outcome
Timeframe: 12-monthsPopulation: Analysis includes only subjects with uterine descent \>=stage II at baseline
Analysis includes only subjects with uterine descent \>= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=36 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=7 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=7 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=37 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=11 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=30 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=73 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at One Year Post Procedure
|
86.1 percentage of participant
Interval 70.5 to 95.3
|
100 percentage of participant
Interval 59.0 to 100.0
|
—
|
—
|
100 percentage of participant
Interval 59.0 to 100.0
|
89.2 percentage of participant
Interval 74.6 to 97.0
|
90.9 percentage of participant
Interval 58.7 to 100.0
|
90.0 percentage of participant
Interval 73.5 to 97.9
|
95.9 percentage of participant
Interval 88.5 to 99.1
|
PRIMARY outcome
Timeframe: 12-monthsPopulation: Analysis includes only subjects with anterior vaginal wall prolapse \>= stage II at baseline
Analysis includes only subjects with anterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=73 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=44 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=34 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=127 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at One Year Post Procedure
|
—
|
—
|
71.2 percentage of participant
Interval 59.4 to 81.2
|
85.1 percentage of participant
Interval 71.7 to 93.8
|
—
|
—
|
—
|
58.8 percentage of participant
Interval 40.7 to 75.4
|
87.4 percentage of participant
Interval 80.3 to 92.6
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included.
Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). A higher or increasing score represents an improvement in perceived sexual function versus baseline. Changes in QoL scores between follow-up and baseline were presented. Only those subjects who completed both baseline and follow-up were included.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=67 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=8 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=24 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=16 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=18 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=47 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=9 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=16 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=51 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12
PISQ-12 mean score at 6M
|
37.1 scores on a scale
Standard Deviation 5.7
|
36.8 scores on a scale
Standard Deviation 7.2
|
36.8 scores on a scale
Standard Deviation 4.7
|
35.4 scores on a scale
Standard Deviation 5.9
|
35.4 scores on a scale
Standard Deviation 5.9
|
36.3 scores on a scale
Standard Deviation 5.5
|
35.0 scores on a scale
Standard Deviation 7.7
|
38.1 scores on a scale
Standard Deviation 6.4
|
36.6 scores on a scale
Standard Deviation 6.1
|
|
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12
PISQ-12 mean score at baseline
|
32.5 scores on a scale
Standard Deviation 7.1
|
32.1 scores on a scale
Standard Deviation 5.6
|
34.8 scores on a scale
Standard Deviation 5.5
|
33.4 scores on a scale
Standard Deviation 5.6
|
32.4 scores on a scale
Standard Deviation 6.4
|
34.0 scores on a scale
Standard Deviation 5.9
|
33.9 scores on a scale
Standard Deviation 4.4
|
34.0 scores on a scale
Standard Deviation 4.8
|
32.6 scores on a scale
Standard Deviation 8.1
|
SECONDARY outcome
Timeframe: Approximately 30 minutesProcedural time was measured as the time between the first incision to place the study device and the time to close the vaginal incision for the study device. Procedure duration in minutes
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=141 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=26 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=81 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=56 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=55 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=139 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=35 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=142 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Procedural Time
|
44.8 minutes
Standard Deviation 20.3
|
40.8 minutes
Standard Deviation 17.7
|
50.2 minutes
Standard Deviation 38.3
|
42.4 minutes
Standard Deviation 16.4
|
51.7 minutes
Standard Deviation 23.1
|
45.8 minutes
Standard Deviation 19.2
|
48.6 minutes
Standard Deviation 14.8
|
63.5 minutes
Standard Deviation 19.0
|
54.6 minutes
Standard Deviation 21.5
|
SECONDARY outcome
Timeframe: Approximately 30 minutesEstimated Blood Loss - defined as the estimated blood loss associated with the implantation of the study device, measured in ml
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=139 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=26 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=80 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=56 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=55 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=139 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=35 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=142 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Estimated Blood Loss
|
68.6 milliliters
Standard Deviation 67.8
|
67.7 milliliters
Standard Deviation 43.9
|
48.8 milliliters
Standard Deviation 29.3
|
58.4 milliliters
Standard Deviation 54.7
|
58.9 milliliters
Standard Deviation 44.6
|
55.4 milliliters
Standard Deviation 45.7
|
62.4 milliliters
Standard Deviation 39.0
|
84.4 milliliters
Standard Deviation 60.9
|
75.5 milliliters
Standard Deviation 76.3
|
SECONDARY outcome
Timeframe: Through 24 monthsPopulation: Total subjects experienced major complications(%)
This may have included: perforation of internal organs during the implant procedure; graft erosion; serious infection requiring intravenous antibiotics; death, related to procedure or device; blood loss related to device placement which may have required blood transfusion during the procedure
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=141 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=26 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=81 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=56 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=55 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=139 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=35 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=142 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent of Subjects Experiencing Major Device Related Complications
Perforation
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percent of Subjects Experiencing Major Device Related Complications
Graft erosion
|
0.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percent of Subjects Experiencing Major Device Related Complications
Serious infe
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percent of Subjects Experiencing Major Device Related Complications
Death related to procedure or device
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
|
Percent of Subjects Experiencing Major Device Related Complications
Blood loss
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Through 24 monthsPopulation: Rate of subjects experiencing graft exposure through the vagina (%)
Rate of Graft Extrusion pertains to study device graft exposure/protrusion through the vaginal wall
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=141 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=26 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=81 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=56 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=55 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=139 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=35 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=142 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Rate of Graft Extrusions
|
9.2 Percentage of participants
|
0 Percentage of participants
|
3.7 Percentage of participants
|
5.4 Percentage of participants
|
7.3 Percentage of participants
|
7.9 Percentage of participants
|
0 Percentage of participants
|
5.7 Percentage of participants
|
5.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Through 24 monthsPopulation: Rate of subjects experiencing different type of incontinenece (%)
Rate of subjects experiencing de novo or worsening urinary and or/ anal incontinence
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=141 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=26 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=81 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=56 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=55 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=139 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=35 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=142 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Rates of de Novo or Worsening Urinary and/or Anal Incontinence
Urinary Incontinence - de novo Stress
|
0 Percentage of participants
|
3.8 Percentage of participants
|
12.3 Percentage of participants
|
1.8 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
11.4 Percentage of participants
|
4.2 Percentage of participants
|
|
Rates of de Novo or Worsening Urinary and/or Anal Incontinence
Urinary Incontinence - Worsening Urge
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.8 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
4.3 Percentage of participants
|
2.9 Percentage of participants
|
0.7 Percentage of participants
|
|
Rates of de Novo or Worsening Urinary and/or Anal Incontinence
Urinary Incontinence - worsening Stress
|
0 Percentage of participants
|
0 Percentage of participants
|
8.6 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0.7 Percentage of participants
|
0 Percentage of participants
|
11.4 Percentage of participants
|
0 Percentage of participants
|
|
Rates of de Novo or Worsening Urinary and/or Anal Incontinence
Urinary Incontinence - de novo Urge
|
0 Percentage of participants
|
0 Percentage of participants
|
1.2 Percentage of participants
|
1.8 Percentage of participants
|
1.8 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0.7 Percentage of participants
|
|
Rates of de Novo or Worsening Urinary and/or Anal Incontinence
Urinary Incontinence - de novo Mixed
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.9 Percentage of participants
|
0 Percentage of participants
|
|
Rates of de Novo or Worsening Urinary and/or Anal Incontinence
Urinary Incontinence - Worsening Mixed
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.9 Percentage of participants
|
0.7 Percentage of participants
|
|
Rates of de Novo or Worsening Urinary and/or Anal Incontinence
Fecal Incontinence
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: baseline and 6 weeksPopulation: Changes in pain scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale (scale of 0-10, with 10 indicating "hurts worst") at baseline, and 6 weeks post procedure
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=136 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=25 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=79 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=55 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=53 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=134 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=22 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=34 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=140 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure
Mean level of pain per WBPS at baseline
|
1.9 scores on a scale
Standard Deviation 2.5
|
2.0 scores on a scale
Standard Deviation 2.2
|
1.5 scores on a scale
Standard Deviation 1.8
|
1.2 scores on a scale
Standard Deviation 2.1
|
1.4 scores on a scale
Standard Deviation 2.1
|
1.8 scores on a scale
Standard Deviation 2.2
|
2.1 scores on a scale
Standard Deviation 2.9
|
1.1 scores on a scale
Standard Deviation 1.5
|
1.4 scores on a scale
Standard Deviation 2.0
|
|
Wong-Baker Faces Pain Scale at 6 Weeks Post Procedure
Mean level of pain per WBPS at 6 weeks post-op
|
0.7 scores on a scale
Standard Deviation 1.3
|
0.2 scores on a scale
Standard Deviation 0.6
|
0.9 scores on a scale
Standard Deviation 1.5
|
0.5 scores on a scale
Standard Deviation 1.1
|
0.7 scores on a scale
Standard Deviation 1.4
|
0.6 scores on a scale
Standard Deviation 1.3
|
0.8 scores on a scale
Standard Deviation 1.4
|
0.5 scores on a scale
Standard Deviation 1.0
|
0.7 scores on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=129 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=26 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=73 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=47 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=46 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=131 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=34 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=131 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Patient Satisfaction Questionnaire at 6 Months by Question (Q#1)
Did not answer this question
|
0.8 Percentage of participants
|
0 Percentage of participants
|
5.5 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.3 Percentage of participants
|
0 Percentage of participants
|
2.9 Percentage of participants
|
0.8 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 6 Months by Question (Q#1)
Worse than before surgery
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
4.3 Percentage of participants
|
2.2 Percentage of participants
|
1.5 Percentage of participants
|
0 Percentage of participants
|
2.9 Percentage of participants
|
1.5 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 6 Months by Question (Q#1)
No improvement from before surgery
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0.8 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.5 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 6 Months by Question (Q#1)
Some improvement from before surgery
|
17.1 Percentage of participants
|
15.4 Percentage of participants
|
8.2 Percentage of participants
|
21.3 Percentage of participants
|
8.7 Percentage of participants
|
21.4 Percentage of participants
|
13.0 Percentage of participants
|
11.8 Percentage of participants
|
12.2 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 6 Months by Question (Q#1)
A lot of improvement from before surgery
|
82.2 Percentage of participants
|
84.6 Percentage of participants
|
86.3 Percentage of participants
|
74.5 Percentage of participants
|
89.1 Percentage of participants
|
74.0 Percentage of participants
|
87.0 Percentage of participants
|
82.4 Percentage of participants
|
84.0 Percentage of participants
|
SECONDARY outcome
Timeframe: Through 24 monthsPopulation: Percentage of total subjects experienced surgical revision (%)
The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=141 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=26 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=81 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=56 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=55 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=139 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=35 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=142 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Surgical Revision Rate
|
7.1 Percentage of participants
|
0 Percentage of participants
|
11.1 Percentage of participants
|
5.4 Percentage of participants
|
3.6 Percentage of participants
|
8.6 Percentage of participants
|
4.3 Percentage of participants
|
25.7 Percentage of participants
|
9.2 Percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: POP-Q analysis employed last failure carried forward method, which carries subject's objective failure at previous visits if the results are missing in the visit of interest. It's also considers re-operation for recurrent in study compartment as failure. 95% CI calculated via binominal distribution including only subjects w/POP-Q≥II at baseline.
The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=125 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=26 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=73 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=47 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=46 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=126 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=34 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=131 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months
Posterior Compartment Success
|
94.4 Percentage of participants
Interval 88.8 to 97.7
|
100 Percentage of participants
Interval 86.8 to 100.0
|
NA Percentage of participants
Phase device does not treat this compartment
|
NA Percentage of participants
Phase device does not treat this compartment
|
91.3 Percentage of participants
Interval 79.2 to 97.6
|
96.8 Percentage of participants
Interval 92.1 to 99.1
|
100 Percentage of participants
Interval 85.2 to 100.0
|
NA Percentage of participants
Phase device does not treat this compartment
|
NA Percentage of participants
Phase device does not treat this compartment
|
|
Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months
Apical Compartment Success
|
94.7 Percentage of participants
Interval 82.3 to 99.4
|
100 Percentage of participants
Interval 59.0 to 100.0
|
NA Percentage of participants
Phase device does not treat this compartment
|
NA Percentage of participants
Phase device does not treat this compartment
|
100 Percentage of participants
Interval 66.4 to 100.0
|
92.5 Percentage of participants
Interval 79.6 to 98.4
|
90.9 Percentage of participants
Interval 58.7 to 99.8
|
90.0 Percentage of participants
Interval 73.5 to 97.9
|
98.8 Percentage of participants
Interval 93.4 to 100.0
|
|
Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 6 Months
Anterior Compartment Success
|
NA Percentage of participants
Phase device does not treat this compartment
|
NA Percentage of participants
Phase device does not treat this compartment
|
76.7 Percentage of participants
Interval 65.4 to 85.8
|
91.5 Percentage of participants
Interval 79.6 to 97.6
|
NA Percentage of participants
Phase device does not treat this compartment
|
NA Percentage of participants
Phase device does not treat this compartment
|
NA Percentage of participants
Phase device does not treat this compartment
|
61.8 Percentage of participants
Interval 43.6 to 77.8
|
86.3 Percentage of participants
Interval 79.2 to 91.6
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: POP-Q analysis employed last failure carried forward method, which carries subject's objective failure at previous visits if the results are missing in the visit of interest. It's also considers re-operation for recurrent in study compartment as failure. 95% CI calculated via binominal distribution including only subjects w/POP-Q≥II at baseline.
The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline. Note: 1. Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII 2. Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=108 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=23 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=68 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=46 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=44 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=106 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=125 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months
Posterior Compartment Success
|
93.5 Percentage of participants
Interval 87.1 to 97.4
|
95.7 Percentage of participants
Interval 78.1 to 99.9
|
NA Percentage of participants
Phase device does not treat this compartment
|
NA Percentage of participants
Phase device does not treat this compartment
|
90.9 Percentage of participants
Interval 78.3 to 97.5
|
91.5 Percentage of participants
Interval 84.5 to 96.0
|
90.9 Percentage of participants
Interval 58.7 to 99.8
|
—
|
NA Percentage of participants
Phase device does not treat this compartment
|
|
Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months
Apical Compartment Success
|
84.4 Percentage of participants
Interval 67.2 to 94.7
|
100 Percentage of participants
Interval 54.1 to 100.0
|
NA Percentage of participants
Phase device does not treat this compartment
|
NA Percentage of participants
Phase device does not treat this compartment
|
75.0 Percentage of participants
Interval 42.1 to 99.6
|
88.2 Percentage of participants
Interval 72.5 to 96.7
|
100 Percentage of participants
Interval 85.2 to 100.0
|
—
|
96.2 Percentage of participants
Interval 89.3 to 99.2
|
|
Percent of Subjects With an ICS POP-Q Stage of </= Stage I at 24 Months
Anterior Compartment Success
|
NA Percentage of participants
Phase device does not treat this compartment
|
NA Percentage of participants
Phase device does not treat this compartment
|
69.1 Percentage of participants
Interval 56.7 to 79.8
|
87.0 Percentage of participants
Interval 73.7 to 95.1
|
NA Percentage of participants
Phase device does not treat this compartment
|
NA Percentage of participants
Phase device does not treat this compartment
|
NA Percentage of participants
Phase device does not treat this compartment
|
—
|
81.6 Percentage of participants
Interval 73.7 to 88.0
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=119 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=24 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=71 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=45 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=44 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=126 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=34 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=125 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Patient Satisfaction Questionnaire at 12 Months by Question (Q#1)
A lot of improvement from before surgery
|
80.7 Percentage of participants
|
79.2 Percentage of participants
|
78.9 Percentage of participants
|
86.7 Percentage of participants
|
93.2 Percentage of participants
|
71.4 Percentage of participants
|
73.9 Percentage of participants
|
88.2 Percentage of participants
|
90.4 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 12 Months by Question (Q#1)
Did not answer this question
|
0 Percentage of participants
|
4.2 Percentage of participants
|
7.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.6 Percentage of participants
|
0 Percentage of participants
|
2.9 Percentage of participants
|
0 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 12 Months by Question (Q#1)
Worse than before surgery
|
1.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.6 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0.8 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 12 Months by Question (Q#1)
No improvement from before surgery
|
0 Percentage of participants
|
4.2 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.3 Percentage of participants
|
2.4 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.4 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 12 Months by Question (Q#1)
Some improvement from before surgery
|
17.6 Percentage of participants
|
12.5 Percentage of participants
|
14.1 Percentage of participants
|
13.3 Percentage of participants
|
4.5 Percentage of participants
|
23.0 Percentage of participants
|
26.1 Percentage of participants
|
8.8 Percentage of participants
|
6.4 Percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Overall, what outcome do you feel you have achieved after having this surgery? (% of subjects answering this question)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure. Note: 1. Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII 2. Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=110 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=23 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=63 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=46 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=42 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=113 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=124 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Patient Satisfaction Questionnaire at 24 Months by Question (Q#1)
Did not answer this question
|
0 Percentage of participants
|
4.3 Percentage of participants
|
11.1 Percentage of participants
|
2.2 Percentage of participants
|
0 Percentage of participants
|
0.9 Percentage of participants
|
0 Percentage of participants
|
—
|
0.8 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 24 Months by Question (Q#1)
Worse than before surgery
|
2.7 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
4.3 Percentage of participants
|
2.4 Percentage of participants
|
4.4 Percentage of participants
|
0 Percentage of participants
|
—
|
0.8 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 24 Months by Question (Q#1)
No improvement from before surgery
|
0.9 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
3.5 Percentage of participants
|
0 Percentage of participants
|
—
|
1.6 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 24 Months by Question (Q#1)
Some improvement from before surgery
|
10.9 Percentage of participants
|
4.3 Percentage of participants
|
7.9 Percentage of participants
|
17.4 Percentage of participants
|
11.9 Percentage of participants
|
20.4 Percentage of participants
|
30.4 Percentage of participants
|
—
|
12.1 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 24 Months by Question (Q#1)
A lot of improvement from before surgery
|
85.5 Percentage of participants
|
91.3 Percentage of participants
|
81.0 Percentage of participants
|
76.1 Percentage of participants
|
85.7 Percentage of participants
|
70.8 Percentage of participants
|
69.6 Percentage of participants
|
—
|
84.7 Percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=129 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=26 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=73 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=47 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=46 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=131 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=34 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=131 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Patient Satisfaction Questionnaire at 6 Months by Question (Q#2)
Did not answer this question
|
0.8 Percentage of participants
|
0 Percentage of participants
|
5.5 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0.8 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 6 Months by Question (Q#2)
Not at all satisfied
|
0.8 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
1.5 Percentage of participants
|
0 Percentage of participants
|
2.9 Percentage of participants
|
3.1 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 6 Months by Question (Q#2)
Slightly satisfied
|
0.8 Percentage of participants
|
3.8 Percentage of participants
|
0 Percentage of participants
|
2.1 Percentage of participants
|
2.2 Percentage of participants
|
4.6 Percentage of participants
|
0 Percentage of participants
|
2.9 Percentage of participants
|
1.5 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 6 Months by Question (Q#2)
Moderately satisfied
|
11.6 Percentage of participants
|
3.8 Percentage of participants
|
6.8 Percentage of participants
|
6.4 Percentage of participants
|
4.3 Percentage of participants
|
12.2 Percentage of participants
|
0 Percentage of participants
|
5.9 Percentage of participants
|
5.3 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 6 Months by Question (Q#2)
Very satisfied
|
34.1 Percentage of participants
|
38.5 Percentage of participants
|
47.9 Percentage of participants
|
46.8 Percentage of participants
|
34.8 Percentage of participants
|
38.2 Percentage of participants
|
47.8 Percentage of participants
|
61.8 Percentage of participants
|
40.5 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 6 Months by Question (Q#2)
Extremely satisfied
|
51.9 Percentage of participants
|
53.8 Percentage of participants
|
39.7 Percentage of participants
|
44.7 Percentage of participants
|
58.7 Percentage of participants
|
41.2 Percentage of participants
|
52.2 Percentage of participants
|
26.5 Percentage of participants
|
48.9 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=119 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=24 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=71 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=45 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=44 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=126 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=34 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=125 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Patient Satisfaction Questionnaire at 12 Months by Question (Q#2)
Moderately satisfied
|
13.4 Percentage of participants
|
8.3 Percentage of participants
|
9.9 Percentage of participants
|
17.8 Percentage of participants
|
6.8 Percentage of participants
|
13.5 Percentage of participants
|
4.3 Percentage of participants
|
8.8 Percentage of participants
|
3.2 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 12 Months by Question (Q#2)
Very satisfied
|
32.8 Percentage of participants
|
33.3 Percentage of participants
|
45.1 Percentage of participants
|
40 Percentage of participants
|
40.9 Percentage of participants
|
42.1 Percentage of participants
|
26.1 Percentage of participants
|
52.9 Percentage of participants
|
32.8 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 12 Months by Question (Q#2)
Extremely satisfied
|
48.7 Percentage of participants
|
50 Percentage of participants
|
38.0 Percentage of participants
|
42.2 Percentage of participants
|
50.0 Percentage of participants
|
38.9 Percentage of participants
|
60.9 Percentage of participants
|
35.3 Percentage of participants
|
58.4 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 12 Months by Question (Q#2)
Did not answer this question
|
0 Percentage of participants
|
4.2 Percentage of participants
|
7.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0.8 Percentage of participants
|
0 Percentage of participants
|
2.9 Percentage of participants
|
0 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 12 Months by Question (Q#2)
Not at all satisfied
|
0.8 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.4 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0.8 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 12 Months by Question (Q#2)
Slightly satisfied
|
4.2 Percentage of participants
|
4.2 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.3 Percentage of participants
|
2.4 Percentage of participants
|
8.7 Percentage of participants
|
0 Percentage of participants
|
4.8 Percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: How satisfied are you with the outcome of your prolapse surgery? (% of subjects answering this question)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure. Note: 1. Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII 2. Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=110 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=23 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=63 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=46 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=42 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=113 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=124 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Patient Satisfaction Questionnaire at 24 Months by Question (Q#2)
Not at all satisfied
|
3.6 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
4.3 Percentage of participants
|
2.4 Percentage of participants
|
2.7 Percentage of participants
|
0 Percentage of participants
|
—
|
2.4 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 24 Months by Question (Q#2)
Did not answer this question
|
0 Percentage of participants
|
4.3 Percentage of participants
|
11.1 Percentage of participants
|
2.2 Percentage of participants
|
0 Percentage of participants
|
0.9 Percentage of participants
|
0 Percentage of participants
|
—
|
0.8 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 24 Months by Question (Q#2)
Slightly satisfied
|
1.8 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.2 Percentage of participants
|
4.8 Percentage of participants
|
8.0 Percentage of participants
|
0 Percentage of participants
|
—
|
3.2 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 24 Months by Question (Q#2)
Very satisfied
|
23.6 Percentage of participants
|
26.1 Percentage of participants
|
44.4 Percentage of participants
|
41.3 Percentage of participants
|
35.7 Percentage of participants
|
40.7 Percentage of participants
|
47.8 Percentage of participants
|
—
|
29.8 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 24 Months by Question (Q#2)
Moderately satisfied
|
11.8 Percentage of participants
|
4.3 Percentage of participants
|
6.3 Percentage of participants
|
8.7 Percentage of participants
|
9.5 Percentage of participants
|
9.7 Percentage of participants
|
8.7 Percentage of participants
|
—
|
5.6 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 24 Months by Question (Q#2)
Extremely satisfied
|
59.1 Percentage of participants
|
65.2 Percentage of participants
|
38.1 Percentage of participants
|
41.3 Percentage of participants
|
47.6 Percentage of participants
|
38.1 Percentage of participants
|
43.5 Percentage of participants
|
—
|
58.1 Percentage of participants
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 6 months post-procedure.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=129 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=26 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=73 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=47 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=46 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=131 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=34 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=131 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Patient Satisfaction Questionnaire at 6 Months by Question (Q#3)
Did not answer this question
|
2.3 Percentage of participants
|
0 Percentage of participants
|
5.5 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.3 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0.8 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 6 Months by Question (Q#3)
Yes
|
94.6 Percentage of participants
|
100 Percentage of participants
|
94.5 Percentage of participants
|
95.7 Percentage of participants
|
93.5 Percentage of participants
|
96.9 Percentage of participants
|
100 Percentage of participants
|
97.1 Percentage of participants
|
96.9 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 6 Months by Question (Q#3)
No
|
3.1 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
4.3 Percentage of participants
|
6.5 Percentage of participants
|
0.8 Percentage of participants
|
0 Percentage of participants
|
2.9 Percentage of participants
|
2.3 Percentage of participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 12 months post-procedure.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=119 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=24 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=71 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=45 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=44 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=126 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=34 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=125 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Patient Satisfaction Questionnaire at 12 Months by Question (Q#3)
Did not answer this question
|
1.7 Percentage of participants
|
4.2 Percentage of participants
|
7.0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.4 Percentage of participants
|
0 Percentage of participants
|
5.9 Percentage of participants
|
1.6 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 12 Months by Question (Q#3)
Yes
|
92.4 Percentage of participants
|
95.8 Percentage of participants
|
93.0 Percentage of participants
|
100 Percentage of participants
|
97.7 Percentage of participants
|
96.0 Percentage of participants
|
95.7 Percentage of participants
|
94.1 Percentage of participants
|
96.8 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 12 Months by Question (Q#3)
No
|
5.9 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
0 Percentage of participants
|
2.3 Percentage of participants
|
1.6 Percentage of participants
|
4.3 Percentage of participants
|
0 Percentage of participants
|
1.6 Percentage of participants
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Would you recommend this procedure to a friend suffering from prolapse? (% of subjects answering this question)
Subject satisfaction with experience and outcomes of the procedure, as reported on the Patient Satisfaction Questionnaires at 24 months post-procedure. Note: 1. Phase VI ended after 12M follow up visit because the next generation of the study device was already under clinical evaluation in Phase VII 2. Phase II ended early before all subjects reached their 24M visit because the study device is no longer marketed due to release of models with enhancements to the design
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=110 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=23 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=63 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=46 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=42 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=113 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=124 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Patient Satisfaction Questionnaire at 24 Months by Question (Q#3)
Did not answer this question
|
0.9 Percentage of participants
|
4.3 Percentage of participants
|
11.1 Percentage of participants
|
2.2 Percentage of participants
|
0 Percentage of participants
|
0.9 Percentage of participants
|
0 Percentage of participants
|
—
|
2.4 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 24 Months by Question (Q#3)
Yes
|
90.9 Percentage of participants
|
95.7 Percentage of participants
|
87.3 Percentage of participants
|
93.5 Percentage of participants
|
95.2 Percentage of participants
|
92.0 Percentage of participants
|
95.7 Percentage of participants
|
—
|
94.4 Percentage of participants
|
|
Patient Satisfaction Questionnaire at 24 Months by Question (Q#3)
No
|
8.2 Percentage of participants
|
0 Percentage of participants
|
1.6 Percentage of participants
|
4.3 Percentage of participants
|
4.8 Percentage of participants
|
7.1 Percentage of participants
|
4.3 Percentage of participants
|
—
|
3.2 Percentage of participants
|
SECONDARY outcome
Timeframe: baseline and 3 monthsPopulation: Changes in pain scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Pain - defined as the level of pain or discomfort associated with the pelvic area measured by the Wong-Baker Faces Pain Scale at baseline and 3 months post procedure
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=134 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=25 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=77 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=37 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=38 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=123 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=33 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=131 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Wong-Baker Faces Pain Scale at 3 Months Post Procedure
Mean level of pain per WBPS at baseline
|
1.9 Percentage of participants
Standard Deviation 2.5
|
2.0 Percentage of participants
Standard Deviation 2.2
|
1.5 Percentage of participants
Standard Deviation 1.8
|
1.2 Percentage of participants
Standard Deviation 2.2
|
1.6 Percentage of participants
Standard Deviation 2.2
|
1.7 Percentage of participants
Standard Deviation 2.0
|
2.2 Percentage of participants
Standard Deviation 2.8
|
1.2 Percentage of participants
Standard Deviation 1.5
|
1.4 Percentage of participants
Standard Deviation 2.0
|
|
Wong-Baker Faces Pain Scale at 3 Months Post Procedure
Mean level of pain per WBPS at 3 months post-op
|
0.5 Percentage of participants
Standard Deviation 1.0
|
0.2 Percentage of participants
Standard Deviation 0.6
|
0.9 Percentage of participants
Standard Deviation 1.5
|
0.2 Percentage of participants
Standard Deviation 0.6
|
0.2 Percentage of participants
Standard Deviation 0.6
|
0.3 Percentage of participants
Standard Deviation 0.9
|
0.4 Percentage of participants
Standard Deviation 0.8
|
0.4 Percentage of participants
Standard Deviation 1.0
|
0.5 Percentage of participants
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=62 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=9 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=22 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=15 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=15 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=48 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=9 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=18 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=48 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12
PISQ-12 mean score at baseline
|
33.4 Percentage of participants
Standard Deviation 7.3
|
31.7 Percentage of participants
Standard Deviation 5.4
|
35.3 Percentage of participants
Standard Deviation 5.3
|
32.8 Percentage of participants
Standard Deviation 5.5
|
33.0 Percentage of participants
Standard Deviation 6.2
|
34.1 Percentage of participants
Standard Deviation 6.1
|
34.3 Percentage of participants
Standard Deviation 4.5
|
33.4 Percentage of participants
Standard Deviation 4.8
|
31.9 Percentage of participants
Standard Deviation 8.4
|
|
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12
PISQ-12 mean score at 12M
|
37.2 Percentage of participants
Standard Deviation 5.9
|
33.8 Percentage of participants
Standard Deviation 9.3
|
36.3 Percentage of participants
Standard Deviation 4.9
|
34.9 Percentage of participants
Standard Deviation 5.6
|
36.4 Percentage of participants
Standard Deviation 5.8
|
36.5 Percentage of participants
Standard Deviation 5.5
|
35.6 Percentage of participants
Standard Deviation 5.5
|
37.7 Percentage of participants
Standard Deviation 5.8
|
37.4 Percentage of participants
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: baseline and 24 monthsPopulation: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Quality of Life as measure by Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=56 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=9 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=22 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=16 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=13 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=37 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=8 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=45 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12
PISQ-12 mean score at 24M
|
36.9 Percentage of participants
Standard Deviation 6.4
|
36.6 Percentage of participants
Standard Deviation 5.3
|
36.0 Percentage of participants
Standard Deviation 4.4
|
35.3 Percentage of participants
Standard Deviation 4.6
|
35.9 Percentage of participants
Standard Deviation 4.8
|
36.6 Percentage of participants
Standard Deviation 6.5
|
34.6 Percentage of participants
Standard Deviation 5.5
|
—
|
36.3 Percentage of participants
Standard Deviation 6.1
|
|
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PISQ-12
PISQ-12 mean score at baseline
|
32.4 Percentage of participants
Standard Deviation 7.4
|
31.7 Percentage of participants
Standard Deviation 5.4
|
34.5 Percentage of participants
Standard Deviation 6.5
|
32.4 Percentage of participants
Standard Deviation 5.3
|
31.9 Percentage of participants
Standard Deviation 5.2
|
34.9 Percentage of participants
Standard Deviation 5.8
|
33.6 Percentage of participants
Standard Deviation 4.2
|
—
|
32.0 Percentage of participants
Standard Deviation 8.4
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented. .
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=124 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=25 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=65 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=47 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=45 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=123 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=30 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=127 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M
PFIQ-7 mean score at baseline
|
70.4 Percentage of participants
Standard Deviation 72.2
|
68.2 Percentage of participants
Standard Deviation 62.8
|
54.9 Percentage of participants
Standard Deviation 55.7
|
61.5 Percentage of participants
Standard Deviation 75.7
|
58.9 Percentage of participants
Standard Deviation 70.1
|
65.4 Percentage of participants
Standard Deviation 59.8
|
60.2 Percentage of participants
Standard Deviation 40.0
|
71.4 Percentage of participants
Standard Deviation 67.2
|
59.8 Percentage of participants
Standard Deviation 61.1
|
|
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 6M
PFIQ-7 mean score at 6M
|
16.3 Percentage of participants
Standard Deviation 35.7
|
21.7 Percentage of participants
Standard Deviation 44.0
|
9.9 Percentage of participants
Standard Deviation 21.1
|
8.4 Percentage of participants
Standard Deviation 20.5
|
9.2 Percentage of participants
Standard Deviation 28.3
|
22.3 Percentage of participants
Standard Deviation 40.8
|
6.0 Percentage of participants
Standard Deviation 13.6
|
22.8 Percentage of participants
Standard Deviation 36.5
|
12.9 Percentage of participants
Standard Deviation 29.0
|
SECONDARY outcome
Timeframe: baseline and 12 monthsPopulation: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=117 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=22 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=67 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=45 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=42 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=120 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=28 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=122 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M
PFIQ-7 mean score at baseline
|
64.9 Percentage of participants
Standard Deviation 70.5
|
59.3 Percentage of participants
Standard Deviation 48.2
|
59.1 Percentage of participants
Standard Deviation 57.4
|
61.7 Percentage of participants
Standard Deviation 74.6
|
57.5 Percentage of participants
Standard Deviation 65.0
|
65.6 Percentage of participants
Standard Deviation 59.7
|
60.2 Percentage of participants
Standard Deviation 40.0
|
73.0 Percentage of participants
Standard Deviation 68.1
|
55.8 Percentage of participants
Standard Deviation 60.5
|
|
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 12M
PFIQ-7 mean score at 12M
|
13.1 Percentage of participants
Standard Deviation 27.8
|
10.0 Percentage of participants
Standard Deviation 19.8
|
9.1 Percentage of participants
Standard Deviation 16.0
|
10.7 Percentage of participants
Standard Deviation 21.8
|
8.8 Percentage of participants
Standard Deviation 26.7
|
17.9 Percentage of participants
Standard Deviation 39.9
|
8.5 Percentage of participants
Standard Deviation 17.3
|
8.7 Percentage of participants
Standard Deviation 13.6
|
14.0 Percentage of participants
Standard Deviation 39.0
|
SECONDARY outcome
Timeframe: baseline and 24 monthsPopulation: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Quality of Life as measure by Pelvic Floor Impact Questionnaire - Short Form 7(PFIQ-7) QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=108 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=21 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=55 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=45 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=41 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=108 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=121 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M
PFIQ-7 mean score at baseline
|
59.1 Percentage of participants
Standard Deviation 63.8
|
55.6 Percentage of participants
Standard Deviation 46.0
|
60.9 Percentage of participants
Standard Deviation 59.3
|
56.5 Percentage of participants
Standard Deviation 71.6
|
59.0 Percentage of participants
Standard Deviation 69.5
|
64.3 Percentage of participants
Standard Deviation 56.5
|
60.2 Percentage of participants
Standard Deviation 40.0
|
—
|
54.8 Percentage of participants
Standard Deviation 56.1
|
|
QoL Status - Defined as the Improvement in Subjects' QoL Over Baseline Values as Measured in Three Questionnaires Post Procedure: PFIQ-7 at 24M
PFIQ-7 mean score at 24M
|
15.8 Percentage of participants
Standard Deviation 40.9
|
5.0 Percentage of participants
Standard Deviation 8.0
|
11.9 Percentage of participants
Standard Deviation 27.8
|
10.5 Percentage of participants
Standard Deviation 36.1
|
7.8 Percentage of participants
Standard Deviation 23.4
|
17.9 Percentage of participants
Standard Deviation 34.7
|
9.7 Percentage of participants
Standard Deviation 15.0
|
—
|
9.3 Percentage of participants
Standard Deviation 24.8
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: Changes in QoL scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Quality of Life as measure by PFDI subscale UDI. UDI scale ranges from 0-100 with 100 representing the most urinary distress. Changes in UDI scores between follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=128 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=26 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=64 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=46 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=45 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=130 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=34 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=130 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M
PFDI- UDI mean score at baseline
|
98.4 scores on a scale
Standard Deviation 59.6
|
106.7 scores on a scale
Standard Deviation 63.4
|
65.5 scores on a scale
Standard Deviation 34.5
|
93.2 scores on a scale
Standard Deviation 55.1
|
93.0 scores on a scale
Standard Deviation 55.0
|
97.6 scores on a scale
Standard Deviation 59.8
|
83.0 scores on a scale
Standard Deviation 40.4
|
75.5 scores on a scale
Standard Deviation 54.2
|
87.0 scores on a scale
Standard Deviation 55.5
|
|
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI (Pelvic Floor Distress Inventory) Sub-scale UDI (Urinary Distress Inventory) at 6M
PFDI- UDI mean score at 6M
|
29.1 scores on a scale
Standard Deviation 37.2
|
36.4 scores on a scale
Standard Deviation 38.4
|
15.4 scores on a scale
Standard Deviation 19.1
|
21.8 scores on a scale
Standard Deviation 22.4
|
29.2 scores on a scale
Standard Deviation 37.7
|
31.2 scores on a scale
Standard Deviation 35.6
|
14.6 scores on a scale
Standard Deviation 23.4
|
29.7 scores on a scale
Standard Deviation 33.5
|
23.2 scores on a scale
Standard Deviation 27.2
|
SECONDARY outcome
Timeframe: baseline and 12 monthsPopulation: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=119 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=24 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=63 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=45 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=44 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=126 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=34 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=125 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M
PFDI- UDI mean score at 12M
|
34.8 Percentage of participants
Standard Deviation 44.3
|
28.3 Percentage of participants
Standard Deviation 40.7
|
14.0 Percentage of participants
Standard Deviation 14.6
|
22.8 Percentage of participants
Standard Deviation 25.4
|
20.3 Percentage of participants
Standard Deviation 28.9
|
33.0 Percentage of participants
Standard Deviation 36.5
|
19.8 Percentage of participants
Standard Deviation 22.6
|
26.4 Percentage of participants
Standard Deviation 30.8
|
21.0 Percentage of participants
Standard Deviation 28.1
|
|
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 12M
PFDI- UDI mean score at baseline
|
97.5 Percentage of participants
Standard Deviation 59.1
|
103.6 Percentage of participants
Standard Deviation 53.1
|
66.7 Percentage of participants
Standard Deviation 33.7
|
92.4 Percentage of participants
Standard Deviation 51.7
|
93.4 Percentage of participants
Standard Deviation 54.4
|
97.6 Percentage of participants
Standard Deviation 58.6
|
83.0 Percentage of participants
Standard Deviation 40.4
|
75.5 Percentage of participants
Standard Deviation 54.2
|
84.4 Percentage of participants
Standard Deviation 50.8
|
SECONDARY outcome
Timeframe: baseline and 24 monthsPopulation: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=110 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=22 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=55 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=45 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=42 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=113 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=124 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M
PFDI- UDI mean score at baseline
|
96.5 Percentage of participants
Standard Deviation 56.7
|
94.9 Percentage of participants
Standard Deviation 55.8
|
69.9 Percentage of participants
Standard Deviation 34.5
|
89.6 Percentage of participants
Standard Deviation 51.5
|
95.8 Percentage of participants
Standard Deviation 56.9
|
97.6 Percentage of participants
Standard Deviation 57.1
|
83.0 Percentage of participants
Standard Deviation 40.4
|
—
|
82.5 Percentage of participants
Standard Deviation 50.6
|
|
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale UDI (Urinary Distress Inventory) at 24M
PFDI- UDI mean score at 24M
|
28.1 Percentage of participants
Standard Deviation 35.7
|
13.2 Percentage of participants
Standard Deviation 17.1
|
19.8 Percentage of participants
Standard Deviation 22.7
|
20.3 Percentage of participants
Standard Deviation 21.8
|
29.8 Percentage of participants
Standard Deviation 39.1
|
29.4 Percentage of participants
Standard Deviation 30.9
|
15.1 Percentage of participants
Standard Deviation 14.1
|
—
|
20.5 Percentage of participants
Standard Deviation 25.0
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=127 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=26 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=63 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=47 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=46 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=130 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=34 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=130 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M
PFDI- POPDI mean score at baseline
|
137.0 Percentage of participants
Standard Deviation 69.9
|
128.9 Percentage of participants
Standard Deviation 65.9
|
102.3 Percentage of participants
Standard Deviation 45.4
|
112.0 Percentage of participants
Standard Deviation 67.2
|
115.7 Percentage of participants
Standard Deviation 69.9
|
122.7 Percentage of participants
Standard Deviation 64.3
|
115.5 Percentage of participants
Standard Deviation 53.5
|
105.4 Percentage of participants
Standard Deviation 61.3
|
107.8 Percentage of participants
Standard Deviation 65.9
|
|
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 6M
PFDI- POPDI mean score at 6M
|
37.5 Percentage of participants
Standard Deviation 43.4
|
34.7 Percentage of participants
Standard Deviation 48.8
|
27.8 Percentage of participants
Standard Deviation 34.8
|
19.1 Percentage of participants
Standard Deviation 21.9
|
30.3 Percentage of participants
Standard Deviation 35.2
|
42.9 Percentage of participants
Standard Deviation 50.9
|
21.6 Percentage of participants
Standard Deviation 24.4
|
36.1 Percentage of participants
Standard Deviation 48.3
|
31.8 Percentage of participants
Standard Deviation 40.7
|
SECONDARY outcome
Timeframe: baseline and 6 monthsPopulation: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=127 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=26 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=63 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=46 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=45 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=128 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=33 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=128 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M
PFDI- CRADI mean score at baseline
|
129.6 Percentage of participants
Standard Deviation 88.1
|
125.8 Percentage of participants
Standard Deviation 83.3
|
52.6 Percentage of participants
Standard Deviation 48.3
|
82.4 Percentage of participants
Standard Deviation 75.1
|
94.1 Percentage of participants
Standard Deviation 71.8
|
110.0 Percentage of participants
Standard Deviation 74.0
|
102.1 Percentage of participants
Standard Deviation 65.9
|
70.5 Percentage of participants
Standard Deviation 60.7
|
80.6 Percentage of participants
Standard Deviation 68.1
|
|
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 6M
PFDI- CRADI mean score at 6M
|
49.2 Percentage of participants
Standard Deviation 63.1
|
45.3 Percentage of participants
Standard Deviation 42.6
|
30.6 Percentage of participants
Standard Deviation 38.9
|
23.4 Percentage of participants
Standard Deviation 28.3
|
31.2 Percentage of participants
Standard Deviation 36.5
|
52.9 Percentage of participants
Standard Deviation 62.5
|
29.0 Percentage of participants
Standard Deviation 35.6
|
41.8 Percentage of participants
Standard Deviation 44.1
|
36.3 Percentage of participants
Standard Deviation 46.5
|
SECONDARY outcome
Timeframe: baseline and 12 monthsPopulation: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=119 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=24 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=62 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=45 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=44 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=126 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=34 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=124 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M
PFDI- POPDI mean score at baseline
|
135.1 Percentage of participants
Standard Deviation 68.9
|
128.2 Percentage of participants
Standard Deviation 55.4
|
103.3 Percentage of participants
Standard Deviation 45.6
|
105.7 Percentage of participants
Standard Deviation 58.8
|
116.1 Percentage of participants
Standard Deviation 65.9
|
122.0 Percentage of participants
Standard Deviation 63.7
|
115.5 Percentage of participants
Standard Deviation 53.5
|
105.4 Percentage of participants
Standard Deviation 61.3
|
104.4 Percentage of participants
Standard Deviation 62.6
|
|
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 12M
PFDI- POPDI mean score at 12M
|
45.2 Percentage of participants
Standard Deviation 49.3
|
42.4 Percentage of participants
Standard Deviation 50.5
|
25.8 Percentage of participants
Standard Deviation 30.3
|
23.6 Percentage of participants
Standard Deviation 30.3
|
19.9 Percentage of participants
Standard Deviation 28.0
|
43.0 Percentage of participants
Standard Deviation 52.5
|
29.9 Percentage of participants
Standard Deviation 27.7
|
32.5 Percentage of participants
Standard Deviation 34.2
|
23.8 Percentage of participants
Standard Deviation 36.5
|
SECONDARY outcome
Timeframe: baseline and 24 monthsPopulation: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=109 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=22 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=54 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=45 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=42 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=113 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=124 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M
PFDI- POPDI mean score at baseline
|
132.4 Percentage of participants
Standard Deviation 68.3
|
113.2 Percentage of participants
Standard Deviation 56.6
|
107.4 Percentage of participants
Standard Deviation 46.3
|
104.7 Percentage of participants
Standard Deviation 60.1
|
116.1 Percentage of participants
Standard Deviation 65.1
|
121.7 Percentage of participants
Standard Deviation 63.0
|
115.5 Percentage of participants
Standard Deviation 53.5
|
—
|
103.3 Percentage of participants
Standard Deviation 59.1
|
|
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale POPDI (Pelvic Organ Prolapse Distress Inventory) at 24M
PFDI- POPDI mean score at 24M
|
36.4 Percentage of participants
Standard Deviation 48.9
|
13.8 Percentage of participants
Standard Deviation 18.1
|
31.7 Percentage of participants
Standard Deviation 37.6
|
23.8 Percentage of participants
Standard Deviation 28.1
|
31.1 Percentage of participants
Standard Deviation 36.7
|
37.6 Percentage of participants
Standard Deviation 51.9
|
21.9 Percentage of participants
Standard Deviation 21.6
|
—
|
24.8 Percentage of participants
Standard Deviation 32.3
|
SECONDARY outcome
Timeframe: baseline and 12 monthsPopulation: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=119 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=24 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=63 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=44 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=43 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=126 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=33 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=121 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M
PFDI- CRADI mean score at baseline
|
129.8 Percentage of participants
Standard Deviation 88.9
|
123.5 Percentage of participants
Standard Deviation 73.8
|
50.9 Percentage of participants
Standard Deviation 49.3
|
85.1 Percentage of participants
Standard Deviation 72.3
|
100.8 Percentage of participants
Standard Deviation 72.8
|
108.2 Percentage of participants
Standard Deviation 71.7
|
102.1 Percentage of participants
Standard Deviation 65.9
|
70.5 Percentage of participants
Standard Deviation 60.7
|
77.2 Percentage of participants
Standard Deviation 66.9
|
|
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 12M
PFDI- CRADI mean score at 12M
|
46.6 Percentage of participants
Standard Deviation 60.5
|
47.3 Percentage of participants
Standard Deviation 51.2
|
27.3 Percentage of participants
Standard Deviation 36.2
|
29.9 Percentage of participants
Standard Deviation 42.1
|
22.7 Percentage of participants
Standard Deviation 30.6
|
49.6 Percentage of participants
Standard Deviation 55.1
|
32.5 Percentage of participants
Standard Deviation 41.0
|
39.4 Percentage of participants
Standard Deviation 42.8
|
29.4 Percentage of participants
Standard Deviation 44.7
|
SECONDARY outcome
Timeframe: baseline and 24 monthsPopulation: QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Quality of Life as measure by Pelvic Floor Distress Inventory(PFDI). PFDI assesses the impact of urinary, prolapse and colorectal distress at baseline and post-op. QoL scores for follow-up and baseline were presented. Only data from those subjects who completed both baseline and follow-up were presented.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=109 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=22 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=54 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=45 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=42 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=112 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=122 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M
PFDI- CRADI mean score at baseline
|
126.9 Percentage of participants
Standard Deviation 84.9
|
110.6 Percentage of participants
Standard Deviation 73.2
|
58.3 Percentage of participants
Standard Deviation 50.4
|
79.8 Percentage of participants
Standard Deviation 73.2
|
95.5 Percentage of participants
Standard Deviation 74.3
|
105.9 Percentage of participants
Standard Deviation 70.3
|
102.1 Percentage of participants
Standard Deviation 65.9
|
—
|
77.2 Percentage of participants
Standard Deviation 65.2
|
|
QoL Status - Improvement in Subjects' QoL Over Baseline Values as Measured by PFDI Sub-scale CRADI (Colo-Rectal-Anal Distress Inventory) at 24M
PFDI- CRADI mean score at 24M
|
40.2 Percentage of participants
Standard Deviation 53.5
|
22.0 Percentage of participants
Standard Deviation 30.6
|
33.7 Percentage of participants
Standard Deviation 41.3
|
25.1 Percentage of participants
Standard Deviation 38.5
|
27.2 Percentage of participants
Standard Deviation 37.8
|
42.7 Percentage of participants
Standard Deviation 52.7
|
29.4 Percentage of participants
Standard Deviation 36.7
|
—
|
28.9 Percentage of participants
Standard Deviation 35.3
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Analysis includes only subjects with posterior vaginal wall prolapse \>= stage II at baseline
Analysis includes only subjects with posterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=125 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=26 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=46 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=126 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 6M Post Procedure
|
94.4 percentage of participants
Interval 88.8 to 97.7
|
100 percentage of participants
Interval 86.8 to 100.0
|
—
|
—
|
91.3 percentage of participants
Interval 79.2 to 97.6
|
96.8 percentage of participants
Interval 92.1 to 99.1
|
100 percentage of participants
Interval 85.2 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Analysis includes only subjects with posterior vaginal wall prolapse \>= stage II at baseline
Analysis includes only subjects with posterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=108 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=23 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=44 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=106 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Posterior Compartment at 24M Post Procedure
|
93.5 percentage of participants
Interval 87.1 to 97.4
|
95.7 percentage of participants
Interval 78.1 to 99.9
|
—
|
—
|
90.9 percentage of participants
Interval 78.3 to 97.5
|
91.5 percentage of participants
Interval 84.5 to 96.0
|
100 percentage of participants
Interval 85.2 to 100.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: Analysis includes only subjects with anterior vaginal wall prolapse \>= stage II at baseline
Analysis includes only subjects with anterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=73 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=47 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=34 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=131 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 6M Post Procedure
|
—
|
—
|
76.7 percentage of participants
Interval 65.4 to 85.8
|
91.5 percentage of participants
Interval 79.6 to 97.6
|
—
|
—
|
—
|
61.8 percentage of participants
Interval 43.6 to 77.8
|
86.3 percentage of participants
Interval 79.2 to 91.6
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: Analysis includes only subjects with anterior vaginal wall prolapse \>= stage II at baseline
Analysis includes only subjects with anterior vaginal wall prolapse \>= stage II at baseline. The POP-Q primary endpoint analysis employed the last observed failure carried forward method (LFCF). Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=68 Participants
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=46 Participants
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=125 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Anterior Compartment at 24M Post Procedure
|
—
|
—
|
69.1 Percentage of participants
Interval 56.7 to 79.8
|
87.0 Percentage of participants
Interval 73.7 to 95.1
|
—
|
—
|
—
|
—
|
81.6 Percentage of participants
Interval 73.7 to 88.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 monthsPopulation: Analysis includes only subjects with uterine descent \>=stage II at baseline
Analysis includes only subjects with uterine descent \>= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=38 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=7 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=9 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=40 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=11 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=30 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=82 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 6M Post Procedure
|
94.7 Percentage of participants
Interval 82.3 to 99.4
|
100 Percentage of participants
Interval 59.0 to 100.0
|
—
|
—
|
100 Percentage of participants
Interval 66.4 to 100.0
|
92.5 Percentage of participants
Interval 79.6 to 98.4
|
90.9 Percentage of participants
Interval 58.7 to 99.8
|
90.0 Percentage of participants
Interval 73.5 to 97.9
|
98.8 Percentage of participants
Interval 93.4 to 100.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 24 monthsPopulation: Analysis includes only subjects with uterine descent \>=stage II at baseline
Analysis includes only subjects with uterine descent \>= stage II at baselineThe POP-Q primary endpoint analysis employed the last observed failure carried forward method. Subjects with a follow-up POP-Q stage ≥ stage II were counted as failures, whereas subjects with a follow-up POP-Q stage \< stage I were counted as successes. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a failure were counted as failures. Subjects who missed the POP-Q at the visit of interest and had the previous visited noted as a success were counted as missing. Exact 95% confidence intervals were calculated via binomial distribution and were limited to subjects having a POPQ ≥ stage II at baseline.
Outcome measures
| Measure |
Phase I (IntePro, US Only)
n=32 Participants
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=6 Participants
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
|
Phase III/IV (Perigee IntePro Lite, US Only)
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=7 Participants
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=34 Participants
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=11 Participants
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, for PROPEL study use only)
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=79 Participants
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Percent of Subjects With an ICS POP-Q Stage of </= Stage I in the Apical Compartment at 24M Post Procedure
|
84.4 Percentage of participants
Interval 67.2 to 94.7
|
100 Percentage of participants
Interval 54.1 to 100.0
|
—
|
—
|
85.4 Percentage of participants
Interval 42.1 to 99.6
|
88.2 Percentage of participants
Interval 72.5 to 96.7
|
90.9 Percentage of participants
Interval 58.7 to 99.8
|
—
|
96.2 Percentage of participants
Interval 89.3 to 99.2
|
Adverse Events
Phase I (IntePro, US Only)
Serious events: 10 serious events
Other events: 30 other events
Deaths: 0 deaths
Phase I (Intexen LP, US Only)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase II (France Only)
Serious events: 11 serious events
Other events: 30 other events
Deaths: 0 deaths
Phase III/IV (Perigee IntePro Lite, US Only)
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Phase III/IV (Apogee IntePro Lite, US Only)
Serious events: 3 serious events
Other events: 20 other events
Deaths: 0 deaths
Phase V (Elevate Posterior IntePro Lite, US & EU)
Serious events: 8 serious events
Other events: 30 other events
Deaths: 0 deaths
Phase V (Elevate Posterior InteXen LP, US Only)
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Phase VI (Elevate Anterior Gen 1, EU Only)
Serious events: 8 serious events
Other events: 7 other events
Deaths: 0 deaths
Phase VII (Elevate Anterior Gen 2, US & EU)
Serious events: 11 serious events
Other events: 62 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase I (IntePro, US Only)
n=141 participants at risk
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=26 participants at risk
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=81 participants at risk
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=56 participants at risk
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=55 participants at risk
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=139 participants at risk
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 participants at risk
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=35 participants at risk
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=142 participants at risk
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
General disorders
any Serious Adverse Event
|
7.1%
10/141 • Number of events 10 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
3.8%
1/26 • Number of events 1 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
13.6%
11/81 • Number of events 11 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
5.4%
3/56 • Number of events 3 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
5.5%
3/55 • Number of events 3 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
5.8%
8/139 • Number of events 8 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
4.3%
1/23 • Number of events 1 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
22.9%
8/35 • Number of events 8 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
7.7%
11/142 • Number of events 11 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
Other adverse events
| Measure |
Phase I (IntePro, US Only)
n=141 participants at risk
AMS Apogee™ with IntePro: Mesh for the treatment of posterior vaginal wall prolapse
|
Phase I (Intexen LP, US Only)
n=26 participants at risk
AMS Apogee™ with InteXen LP: Graft for the treatment of posterior vaginal wall prolapse
|
Phase II (France Only)
n=81 participants at risk
AMS Perigee™ with IntePro: Mesh for the treatment of anterior vaginal wall prolapse.
Phase II ended before all subjects reached their 24M follow up visit because next generation of Perigee was already under trial in Phase III/IV
|
Phase III/IV (Perigee IntePro Lite, US Only)
n=56 participants at risk
AMS Perigee™ with IntePro Lite: Mesh for the treatment of anterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase III/IV (Apogee IntePro Lite, US Only)
n=55 participants at risk
AMS Apogee™ with IntePro Lite: Mesh for the treatment of posterior vaginal wall prolapse Subjects in Phases III and IV were to be implanted with either an Apogee with IntePro Lite device, a Perigee with IntePro Lite device, or both devices
|
Phase V (Elevate Posterior IntePro Lite, US & EU)
n=139 participants at risk
AMS Elevate™ Apical \& Posterior with IntePro Lite: Mesh for the treatment of apical \& posterior vaginal wall prolapse
|
Phase V (Elevate Posterior InteXen LP, US Only)
n=23 participants at risk
AMS Elevate™ Apical \& Posterior with InteXen LP: Graft for the treatment of apical \& posterior vaginal wall prolapse
|
Phase VI (Elevate Anterior Gen 1, EU Only)
n=35 participants at risk
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 1, For PROPEL Study Use Only) Phase VI ended after 12M visit because next generation of Elevate Anterior was already under trial in Phase VII
|
Phase VII (Elevate Anterior Gen 2, US & EU)
n=142 participants at risk
AMS Elevate™ Anterior \& Apical with IntePro Lite: Mesh for the treatment of anterior \& apical vaginal wall prolapse (Generation 2)
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary Tract Infection
|
1.4%
2/141 • Number of events 2 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
0.00%
0/26 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
6.2%
5/81 • Number of events 5 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
7.1%
4/56 • Number of events 4 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
5.5%
3/55 • Number of events 3 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
1.4%
2/139 • Number of events 2 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
4.3%
1/23 • Number of events 1 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
0.00%
0/35 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
5.6%
8/142 • Number of events 9 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
|
Nervous system disorders
Dyspareunia
|
0.71%
1/141 • Number of events 1 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
3.8%
1/26 • Number of events 1 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
1.2%
1/81 • Number of events 1 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
0.00%
0/56 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
1.8%
1/55 • Number of events 1 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
0.00%
0/139 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
0.00%
0/23 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
2.9%
1/35 • Number of events 1 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
4.9%
7/142 • Number of events 7 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
|
Infections and infestations
Infection- Vaginal
|
0.71%
1/141 • Number of events 1 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
0.00%
0/26 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
0.00%
0/81 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
3.6%
2/56 • Number of events 2 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
7.3%
4/55 • Number of events 4 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
1.4%
2/139 • Number of events 2 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
0.00%
0/23 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
0.00%
0/35 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
0.70%
1/142 • Number of events 1 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
|
Surgical and medical procedures
Device Malfunction
|
1.4%
2/141 • Number of events 2 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
0.00%
0/26 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
0.00%
0/81 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
5.4%
3/56 • Number of events 3 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
1.8%
1/55 • Number of events 1 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
0.00%
0/139 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
0.00%
0/23 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
0.00%
0/35 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
0.00%
0/142 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
|
General disorders
Any non-serious adverse events
|
21.3%
30/141 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
11.5%
3/26 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
37.0%
30/81 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
35.7%
20/56 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
36.4%
20/55 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
21.6%
30/139 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
13.0%
3/23 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
20.0%
7/35 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
43.7%
62/142 • The monitoring of AEs occured through the end of the follow up period. Any continuing AEs past the 24M visit or early exit of subject was not followed to resolution.
The Astora Women's Health business is closing and will no longer be able to provide updates to this results section. Specific adverse event data can no longer be provided or updated because the database that holds the raw data is no longer accessible by Astora personnel.
|
Additional Information
Dr. James C Lukban, Professor & Director Division of urogynecology
Eastern Virginia Medical School
Phone: 7574467900
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60