Trial Outcomes & Findings for Uphold LITE Post-Market Surveillance Study (NCT NCT01917968)
NCT ID: NCT01917968
Last Updated: 2021-05-20
Results Overview
Success based on a composite of objective and subjective measures: 1. Objective success was achieved by the subject having an anatomic outcome defined as the leading edge of prolapse at or above the hymen in the operated compartment: * Anterior segment: Leading edge of anterior prolapse was at or above the hymen or POP-Q point Ba ≤ 0. * Apical segment: The vaginal apex did not descend more than one-half into the vaginal canal (i.e., POP-Q point C \< -1/2 TVL) for multi-compartment prolapse or POP-Q point C ≤ 0 for single compartment apical prolapse. 2. Subjective success was achieved if the patient denied symptoms of vaginal bulging per Pelvic Floor Distress Inventory (PFDI-20) question 3, answering "no" or "yes" but "Not at all" bothersome (\< 2). 3. No retreatment for POP: no additional surgical treatment for POP in the segment(s) of the vagina treated at the index surgery or no pessary use since index surgery (i.e., 'treated segment' refers to the target compartment).
COMPLETED
NA
289 participants
36 Months
2021-05-20
Participant Flow
337 subjects were screened and 289 subjects were enrolled in the Uphold LITE Postmarket Surveillance Study. 225 subjects were enrolled in the Uphold LITE arm and 64 subjects in the NTR arm. 421 subjects from the AUGS PFD Registry (146 subjects from BSC's Xenform™ 522 study \[NCT01945580\], 69 subjects from Acell's MatriStem® 522 study, and 206 from Coloplast's 522 Restorelle® study) were pulled into the NTR arm for a total of 485 subjects in the NTR cohort and a total of 710 subjects overall.
Participant milestones
| Measure |
Uphold Lightweight Vaginal Support System
Transvaginal repair with mesh (Uphold LITE)
Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
|
Traditional Native Tissue Repair
Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
|
|---|---|---|
|
Overall Study
STARTED
|
225
|
485
|
|
Overall Study
COMPLETED
|
171
|
401
|
|
Overall Study
NOT COMPLETED
|
54
|
84
|
Reasons for withdrawal
| Measure |
Uphold Lightweight Vaginal Support System
Transvaginal repair with mesh (Uphold LITE)
Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
|
Traditional Native Tissue Repair
Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
|
|---|---|---|
|
Overall Study
Death
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
21
|
39
|
|
Overall Study
Physician Decision
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
20
|
35
|
|
Overall Study
Subject Relocation
|
5
|
1
|
|
Overall Study
36M Missed Visit
|
3
|
2
|
|
Overall Study
Subject Noncompliance to Scheduled 36M Follow Up Visit
|
1
|
0
|
|
Overall Study
Change in Family Circumstances
|
0
|
1
|
|
Overall Study
No Data Available
|
0
|
2
|
Baseline Characteristics
Uphold LITE Post-Market Surveillance Study
Baseline characteristics by cohort
| Measure |
Uphold Lightweight Vaginal Support System
n=225 Participants
Transvaginal repair with mesh (Uphold LITE)
Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
|
Traditional Native Tissue Repair
n=485 Participants
Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
|
Total
n=710 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66.1 Years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
61.8 Years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
63.2 Years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
225 Participants
n=5 Participants
|
485 Participants
n=7 Participants
|
710 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
6 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
219 Participants
n=5 Participants
|
457 Participants
n=7 Participants
|
676 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
210 Participants
n=5 Participants
|
409 Participants
n=7 Participants
|
619 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not disclosed
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
225 participants
n=5 Participants
|
485 participants
n=7 Participants
|
710 participants
n=5 Participants
|
|
Smoking
Current
|
18 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Smoking
Previous
|
59 Participants
n=5 Participants
|
139 Participants
n=7 Participants
|
198 Participants
n=5 Participants
|
|
Smoking
Never
|
147 Participants
n=5 Participants
|
308 Participants
n=7 Participants
|
455 Participants
n=5 Participants
|
|
Smoking
Not Recorded
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Diabetes
|
32 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
95 Participants
n=5 Participants
|
|
Menopausal Status
Premenopausal
|
11 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
|
Menopausal Status
Perimenopausal
|
5 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Menopausal Status
Postmenopausal
|
209 Participants
n=5 Participants
|
404 Participants
n=7 Participants
|
613 Participants
n=5 Participants
|
|
Previous Pelvic Surgery
|
169 Participants
n=5 Participants
|
235 Participants
n=7 Participants
|
404 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 36 MonthsPopulation: 337 subjects were screened and 289 subjects were enrolled in the Uphold LITE Postmarket Surveillance Study. 225 subjects were enrolled in the Uphold LITE arm and 64 subjects in the NTR arm. 421 subjects from the AUGS PFD Registry (146 subjects from BSC's Xenform™ 522 study \[NCT01945580\], 69 subjects from Acell's MatriStem® 522 study, and 206 from Coloplast's 522 Restorelle® study) were pulled into the NTR arm for a total of 485 subjects in the NTR cohort and a total of 710 subjects overall.
Success based on a composite of objective and subjective measures: 1. Objective success was achieved by the subject having an anatomic outcome defined as the leading edge of prolapse at or above the hymen in the operated compartment: * Anterior segment: Leading edge of anterior prolapse was at or above the hymen or POP-Q point Ba ≤ 0. * Apical segment: The vaginal apex did not descend more than one-half into the vaginal canal (i.e., POP-Q point C \< -1/2 TVL) for multi-compartment prolapse or POP-Q point C ≤ 0 for single compartment apical prolapse. 2. Subjective success was achieved if the patient denied symptoms of vaginal bulging per Pelvic Floor Distress Inventory (PFDI-20) question 3, answering "no" or "yes" but "Not at all" bothersome (\< 2). 3. No retreatment for POP: no additional surgical treatment for POP in the segment(s) of the vagina treated at the index surgery or no pessary use since index surgery (i.e., 'treated segment' refers to the target compartment).
Outcome measures
| Measure |
Uphold Lightweight Vaginal Support System
n=225 Participants
Transvaginal repair with mesh (Uphold LITE)
Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
|
Traditional Native Tissue Repair
n=485 Participants
Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
|
Moderate
Measure of Severity
|
Severe
Measure of Severity
|
|---|---|---|---|---|
|
Primary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months
Intent to Treat Analysis
|
201 Participants
|
389 Participants
|
—
|
—
|
|
Primary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months
Per Protocol
|
199 Participants
|
384 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: 36 monthsPopulation: 337 subjects were screened and 289 subjects were enrolled in the Uphold LITE Postmarket Surveillance Study. 225 subjects were enrolled in the Uphold LITE arm and 64 subjects in the NTR arm. 421 subjects from the AUGS PFD Registry (146 subjects from BSC's Xenform™ 522 study \[NCT01945580\], 69 subjects from Acell's MatriStem® 522 study, and 206 from Coloplast's 522 Restorelle® study) were pulled into the NTR arm for a total of 485 subjects in the NTR cohort and a total of 710 subjects overall.
A co-primary endpoint of the study was to achieve non-inferiority of transvaginal repair with Uphold LITE vs. NTR for safety by comparing the overall complication rate (device-related and/or procedure-related SAEs) at 36 months
Outcome measures
| Measure |
Uphold Lightweight Vaginal Support System
n=225 Participants
Transvaginal repair with mesh (Uphold LITE)
Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
|
Traditional Native Tissue Repair
n=485 Participants
Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
|
Moderate
Measure of Severity
|
Severe
Measure of Severity
|
|---|---|---|---|---|
|
Co-Primary Safety Endpoint - Number of Participants With One or More Serious Device-Related and/or Procedure-Related Complications at 36 Months
Intent To Treat Analysis
|
7 Participants
|
13 Participants
|
—
|
—
|
|
Co-Primary Safety Endpoint - Number of Participants With One or More Serious Device-Related and/or Procedure-Related Complications at 36 Months
Per Protocol
|
7 Participants
|
12 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 Month, 12 Months, 18 Months, 24 Months, 36 Months, OverallPopulation: The population includes the 225 subjects in the Transvaginal repair with mesh (Uphold LITE) arm of the study.
Provides a summary of the number of subjects who reported mesh erosion or exposure at each of the study follow-up time points.
Outcome measures
| Measure |
Uphold Lightweight Vaginal Support System
n=225 Participants
Transvaginal repair with mesh (Uphold LITE)
Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
|
Traditional Native Tissue Repair
n=225 Participants
Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
|
Moderate
n=225 Participants
Measure of Severity
|
Severe
n=225 Participants
Measure of Severity
|
|---|---|---|---|---|
|
Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects
Exposure : Within 12 Months
|
5 participants
|
4 participants
|
1 participants
|
0 participants
|
|
Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects
Exposure : Within 18 Months
|
7 participants
|
5 participants
|
2 participants
|
0 participants
|
|
Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects
Exposure : Within 6 Months
|
3 participants
|
2 participants
|
1 participants
|
0 participants
|
|
Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects
Erosion : Within 6 Months
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects
Erosion : Within 12 Months
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects
Erosion : Within 18 Months
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects
Erosion : Within 24 Months
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects
Erosion : Within 36 Months
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects
Erosion : Overall
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects
Exposure : Within 24 Months
|
8 participants
|
6 participants
|
2 participants
|
0 participants
|
|
Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects
Exposure : Within 36 Months
|
9 participants
|
7 participants
|
2 participants
|
0 participants
|
|
Secondary Endpoint - Number of Participants With Mesh Erosion and Exposures Over Time in Intent-to-Treat Subjects
Exposure : Overall
|
11 participants
|
8 participants
|
3 participants
|
0 participants
|
SECONDARY outcome
Timeframe: 36 MonthsPopulation: 337 subjects were screened and 289 subjects were enrolled in the Uphold LITE Postmarket Surveillance Study. 225 subjects were enrolled in the Uphold LITE arm and 64 subjects in the NTR arm. 421 subjects from the AUGS PFD Registry (146 subjects from BSC's Xenform™ 522 study \[NCT01945580\], 69 subjects from Acell's MatriStem® 522 study, and 206 from Coloplast's 522 Restorelle® study) were pulled into the NTR arm for a total of 485 subjects in the NTR cohort and a total of 710 subjects overall.
Number of subjects with the following device-related and/or procedure-related adverse events: de novo dyspareunia, pelvic pain, infection, vaginal shortening, atypical vaginal discharge, neuromuscular problems, vaginal scarring, de novo vaginal bleeding, fistula formation, and/or de novo voiding dysfunction. The Intent-to-Treat (ITT) population includes all enrolled subjects who had a surgery initiated; the As Treated population includes all subjects who successfully completed the surgical procedure. Both ITT and As Treated populations are identical to the Overall Number of Participants Analyzed.
Outcome measures
| Measure |
Uphold Lightweight Vaginal Support System
n=225 Participants
Transvaginal repair with mesh (Uphold LITE)
Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
|
Traditional Native Tissue Repair
n=485 Participants
Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
|
Moderate
Measure of Severity
|
Severe
Measure of Severity
|
|---|---|---|---|---|
|
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
Vaginal Shortening : As treated
|
1 participants
|
0 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
De novo Dyspareunia : Intent-to-treat
|
2 participants
|
6 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
De novo Dyspareunia : As treated
|
2 participants
|
6 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
Pelvic Pain : Intent-to-treat
|
11 participants
|
28 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
Pelvic Pain : As treated
|
11 participants
|
28 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
Infection : Intent-to-treat
|
23 participants
|
68 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
Infection : As treated
|
23 participants
|
68 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
Vaginal Shortening : Intent-to-treat
|
1 participants
|
0 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
Atypical Vaginal Discharge : Intent-to-treat
|
2 participants
|
3 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
Atypical Vaginal Discharge : As treated
|
2 participants
|
3 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
Neuromuscular Problems : Intent-to-treat
|
10 participants
|
14 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
Neuromuscular Problems : As treated
|
10 participants
|
14 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
Vaginal Scarring : Intent-to-treat
|
0 participants
|
1 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
Vaginal Scarring : As treated
|
0 participants
|
1 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
De novo Vaginal Bleeding : Intent-to-treat
|
0 participants
|
7 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
De novo Vaginal Bleeding : As treated
|
0 participants
|
7 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
Fistula Formation : Intent-to-treat
|
0 participants
|
0 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
Fistula Formation : As treated
|
0 participants
|
0 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
De novo Voiding Dysfunction : Intent-to-treat
|
17 participants
|
23 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With One or More Device-Related and/or Procedure-Related Adverse Events
De novo Voiding Dysfunction : As treated
|
17 participants
|
23 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 Month, 12 Months, 18 Months, 24 Months, 36 MonthsPopulation: 225 Uphold LITE arm subjects and 485 Native Tissue Repair arm subjects had available questionnaire data at Baseline. The number of participants at each follow up time point represents subjects who had available questionnaire data at Baseline and the time point indicated.
The Pelvic Floor Distress Inventory-20 (PFDI-20) consists of three components: Pelvic Organ Prolapse Distress Inventory (POPDI; 6 questions), Urinary Distress Inventory (UDI; 6 questions), and Colorectal-Anal Distress Inventory (CRADI; 8 questions). Each individual component score is summed. The total ranges from 0 to 300, with a higher score indicating a greater impact to QOL (i.e., distress symptoms are more noticeable) and a lower score indicating a lesser impact to QOL (i.e., distress symptoms are less noticeable). Reported outcomes are the change from Baseline for the time periods indicated.
Outcome measures
| Measure |
Uphold Lightweight Vaginal Support System
n=225 Participants
Transvaginal repair with mesh (Uphold LITE)
Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
|
Traditional Native Tissue Repair
n=485 Participants
Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
|
Moderate
Measure of Severity
|
Severe
Measure of Severity
|
|---|---|---|---|---|
|
Secondary Endpoint - PFDI-20 Change From Baseline in Intent-to-Treat Subjects
6 Months
|
-78.9 score on a scale
Standard Deviation 57.3
|
-77.7 score on a scale
Standard Deviation 53.2
|
—
|
—
|
|
Secondary Endpoint - PFDI-20 Change From Baseline in Intent-to-Treat Subjects
12 Months
|
-74.8 score on a scale
Standard Deviation 61.6
|
-76.9 score on a scale
Standard Deviation 54.2
|
—
|
—
|
|
Secondary Endpoint - PFDI-20 Change From Baseline in Intent-to-Treat Subjects
18 Months
|
-78.5 score on a scale
Standard Deviation 60.9
|
-77.3 score on a scale
Standard Deviation 53.4
|
—
|
—
|
|
Secondary Endpoint - PFDI-20 Change From Baseline in Intent-to-Treat Subjects
24 Months
|
-81.8 score on a scale
Standard Deviation 56.6
|
-77.5 score on a scale
Standard Deviation 53.9
|
—
|
—
|
|
Secondary Endpoint - PFDI-20 Change From Baseline in Intent-to-Treat Subjects
36 Months
|
-73.5 score on a scale
Standard Deviation 59.4
|
-77.2 score on a scale
Standard Deviation 56.1
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 Month, 12 Months, 18 Months, 24 Months, 36 MonthsPopulation: 222 Uphold LITE arm subjects and 485 Native Tissue Repair arm subjects had available questionnaire data at Baseline. The number of participants at each follow up time point represents subjects who had available questionnaire data at Baseline and the time point indicated.
The Pelvic Floor Impact Questionnaire (PFIQ-7) is composed of 3 separate but related assessments: the Urinary Impact Questionnaire, addresses the impact of urinary incontinence symptoms, the Colorectal-Anal Impact Questionnaire addresses the impact of colorectal-anal or bowel symptoms, and the Pelvic Organ Prolapse Impact Questionnaire addresses impact of vaginal and pelvic symptoms. For each question, the low score (0) corresponds to "not at all" and the high score (3) corresponds to "quite a bit". The scores for the UIQ-7, CRAIQ-7 and POPIQ-7 are additive to yield the final PFIQ-7 score, which ranges from 0-300. A lower score means there is a lesser effect on quality of life.
Outcome measures
| Measure |
Uphold Lightweight Vaginal Support System
n=222 Participants
Transvaginal repair with mesh (Uphold LITE)
Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
|
Traditional Native Tissue Repair
n=485 Participants
Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
|
Moderate
Measure of Severity
|
Severe
Measure of Severity
|
|---|---|---|---|---|
|
Secondary Endpoint - PFIQ-7 Change From Baseline in Intent-to-Treat Subjects
6 Months
|
-51.2 score on a scale
Standard Deviation 59.2
|
-41.0 score on a scale
Standard Deviation 56.1
|
—
|
—
|
|
Secondary Endpoint - PFIQ-7 Change From Baseline in Intent-to-Treat Subjects
12 Months
|
-47.7 score on a scale
Standard Deviation 66.6
|
-41.9 score on a scale
Standard Deviation 55.8
|
—
|
—
|
|
Secondary Endpoint - PFIQ-7 Change From Baseline in Intent-to-Treat Subjects
18 Months
|
-48.8 score on a scale
Standard Deviation 66.4
|
-42.9 score on a scale
Standard Deviation 58.8
|
—
|
—
|
|
Secondary Endpoint - PFIQ-7 Change From Baseline in Intent-to-Treat Subjects
24 Months
|
-50.3 score on a scale
Standard Deviation 62.9
|
-41.5 score on a scale
Standard Deviation 57.6
|
—
|
—
|
|
Secondary Endpoint - PFIQ-7 Change From Baseline in Intent-to-Treat Subjects
36 Months
|
-48.1 score on a scale
Standard Deviation 62.9
|
-41.9 score on a scale
Standard Deviation 55.0
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 Month, 12 Months, 18 Months, 24 Months, 36 MonthsPopulation: 90 Uphold LITE arm subjects and 234 Native Tissue Repair arm subjects had available questionnaire data at Baseline. The number of participants at each follow up time point represents those who had available questionnaire data at Baseline and the time point indicated.
The Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) is a validated short form that can be used to ascertain improvement in sexual function and desire in women undergoing therapy for pelvic organ prolapse. The PISQ-12 consists of 12 questions graded on a five-point Likert scale ranging from 0 (always) to 4 (never). Values range from 0-48 and a higher score indicates better sexual function. Reported outcomes are the change from Baseline for the time periods indicated.
Outcome measures
| Measure |
Uphold Lightweight Vaginal Support System
n=90 Participants
Transvaginal repair with mesh (Uphold LITE)
Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
|
Traditional Native Tissue Repair
n=234 Participants
Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
|
Moderate
Measure of Severity
|
Severe
Measure of Severity
|
|---|---|---|---|---|
|
Secondary Endpoint - PISQ-12 Change From Baseline in Intent-to-Treat Subjects
6 Month
|
4.4 score on a scale
Standard Deviation 6.2
|
4.4 score on a scale
Standard Deviation 6.3
|
—
|
—
|
|
Secondary Endpoint - PISQ-12 Change From Baseline in Intent-to-Treat Subjects
12 Month
|
3.9 score on a scale
Standard Deviation 6.4
|
4.4 score on a scale
Standard Deviation 6.3
|
—
|
—
|
|
Secondary Endpoint - PISQ-12 Change From Baseline in Intent-to-Treat Subjects
18 Month
|
4.1 score on a scale
Standard Deviation 5.7
|
4.0 score on a scale
Standard Deviation 6.2
|
—
|
—
|
|
Secondary Endpoint - PISQ-12 Change From Baseline in Intent-to-Treat Subjects
24 Month
|
4.0 score on a scale
Standard Deviation 6.2
|
4.6 score on a scale
Standard Deviation 6.5
|
—
|
—
|
|
Secondary Endpoint - PISQ-12 Change From Baseline in Intent-to-Treat Subjects
36 Month
|
4.2 score on a scale
Standard Deviation 5.8
|
4.3 score on a scale
Standard Deviation 5.8
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 Month, 12 Months, 18 Months, 24 Months, 36 MonthsPopulation: 225 Uphold LITE arm subjects and 485 Native Tissue Repair arm subjects had available questionnaire data at Baseline. The number of participants at each follow up time point represents subjects who had available questionnaire data at Baseline and the time point indicated.
The TOMUS Pain Score, a visual analog instrument with a scale of 0 (no pain sensation) to 10 (most intense pain sensation imaginable), was used to assess pain associated with surgery for pelvic organ prolapse. There are seven (7) questions each with a maximum score of 10 and a possible score range of 0-70. Reported outcomes are the change from Baseline for the time periods indicated.
Outcome measures
| Measure |
Uphold Lightweight Vaginal Support System
n=225 Participants
Transvaginal repair with mesh (Uphold LITE)
Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
|
Traditional Native Tissue Repair
n=485 Participants
Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
|
Moderate
Measure of Severity
|
Severe
Measure of Severity
|
|---|---|---|---|---|
|
Secondary Endpoint - TOMUS Pain Score Change From Baseline in Intent-to-Treat Subjects
6 Months
|
-3.8 score on a scale
Standard Deviation 8.1
|
-3.3 score on a scale
Standard Deviation 8.3
|
—
|
—
|
|
Secondary Endpoint - TOMUS Pain Score Change From Baseline in Intent-to-Treat Subjects
12 Months
|
-3.4 score on a scale
Standard Deviation 8.3
|
-3.8 score on a scale
Standard Deviation 8.7
|
—
|
—
|
|
Secondary Endpoint - TOMUS Pain Score Change From Baseline in Intent-to-Treat Subjects
18 Months
|
-3.5 score on a scale
Standard Deviation 10.6
|
-4.2 score on a scale
Standard Deviation 9.0
|
—
|
—
|
|
Secondary Endpoint - TOMUS Pain Score Change From Baseline in Intent-to-Treat Subjects
24 Months
|
-3.6 score on a scale
Standard Deviation 8.8
|
-3.9 score on a scale
Standard Deviation 9.1
|
—
|
—
|
|
Secondary Endpoint - TOMUS Pain Score Change From Baseline in Intent-to-Treat Subjects
36 Months
|
-4.3 score on a scale
Standard Deviation 8.7
|
-4.0 score on a scale
Standard Deviation 8.3
|
—
|
—
|
SECONDARY outcome
Timeframe: 6 Month, 12 Months, 18 Months, 24 Months, 36 MonthsPopulation: 289 subjects were enrolled in the Uphold LITE study--225 in the Uphold LITE arm and 64 in the NTR arm. 421 subjects from AUGS PFD Registry (146 subjects from Xenform™ 522 study, 69 subjects from MatriStem® 522 study, and 206 from Restorelle® 522 study) were pulled into the NTR arm for a total of 485 subjects in the NTR cohort and a total of 710 subjects overall. The number of participants for each follow up time point represents subjects who had available questionnaire data at that time point.
The Patient Global Impression of Improvement (PGI-I) for prolapse symptoms is a validated QOL instrument that assesses patient perception of overall improvement after surgical interventions for pelvic organ prolapse. The scale is as follows: 1- Very much better; 2- Much better; 3- A little better; 4- No change; 5- A little worse; 6- Much worse; 7- Very much worse.
Outcome measures
| Measure |
Uphold Lightweight Vaginal Support System
n=225 Participants
Transvaginal repair with mesh (Uphold LITE)
Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
|
Traditional Native Tissue Repair
n=485 Participants
Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
|
Moderate
Measure of Severity
|
Severe
Measure of Severity
|
|---|---|---|---|---|
|
Secondary Endpoint: PGI-I for Prolapse Symptoms in Intent-to-Treat Subjects
6 Month
|
1.4 score on a scale
Standard Deviation 0.7
|
1.3 score on a scale
Standard Deviation 0.7
|
—
|
—
|
|
Secondary Endpoint: PGI-I for Prolapse Symptoms in Intent-to-Treat Subjects
12 Month
|
1.5 score on a scale
Standard Deviation 0.9
|
1.4 score on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Secondary Endpoint: PGI-I for Prolapse Symptoms in Intent-to-Treat Subjects
18 Month
|
1.4 score on a scale
Standard Deviation 0.8
|
1.4 score on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Secondary Endpoint: PGI-I for Prolapse Symptoms in Intent-to-Treat Subjects
24 Month
|
1.4 score on a scale
Standard Deviation 0.9
|
1.4 score on a scale
Standard Deviation 0.9
|
—
|
—
|
|
Secondary Endpoint: PGI-I for Prolapse Symptoms in Intent-to-Treat Subjects
36 Month
|
1.6 score on a scale
Standard Deviation 1.0
|
1.4 score on a scale
Standard Deviation 0.9
|
—
|
—
|
SECONDARY outcome
Timeframe: 36 MonthsPopulation: 337 subjects were screened and 289 subjects were enrolled in the Uphold LITE Postmarket Surveillance Study. 225 subjects were enrolled in the Uphold LITE arm and 64 subjects in the NTR arm. 421 subjects from the AUGS PFD Registry (146 subjects from BSC's Xenform™ 522 study \[NCT01945580\], 69 subjects from Acell's MatriStem® 522 study, and 206 from Coloplast's 522 Restorelle® study) were pulled into the NTR arm for a total of 485 subjects in the NTR cohort and a total of 710 subjects overall.
Compares the office-based and surgical intervention for recurrent prolapse and complications between the Uphold LITE arm and the NTR arm 36 months from the index procedure in the Intent-to-Treat (ITT) and As Treated populations. The ITT population includes all enrolled subjects who had a surgery initiated; the As Treated population includes all subjects who successfully completed the surgical procedure. Both ITT and As Treated populations are identical to the Overall Number of Participants Analyzed.
Outcome measures
| Measure |
Uphold Lightweight Vaginal Support System
n=225 Participants
Transvaginal repair with mesh (Uphold LITE)
Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
|
Traditional Native Tissue Repair
n=485 Participants
Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
|
Moderate
Measure of Severity
|
Severe
Measure of Severity
|
|---|---|---|---|---|
|
Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure
Office-based Intervention for Recurrence : Intent-to-Treat
|
1 participants
|
2 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure
Office-based Intervention for Recurrence : As Treated
|
1 participants
|
2 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure
Surgical Intervention for Recurrence : Intent-to-Treat
|
5 participants
|
15 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure
Surgical Intervention for Recurrence : As Treated
|
5 participants
|
15 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure
Office-based Intervention for Complications : Intent-to-Treat
|
13 participants
|
40 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure
Office-based Intervention for Complications : As Treated
|
13 participants
|
40 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure
Surgical Intervention for Complications : Intent-to-Treat
|
20 participants
|
34 participants
|
—
|
—
|
|
Secondary Endpoint - Number of Participants With Intervention for Recurrent Prolapse and Complications at 36 Months Post Index Procedure
Surgical Intervention for Complications : As Treated
|
20 participants
|
34 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: 36 MonthsPopulation: 337 subjects were screened and 289 subjects were enrolled in the Uphold LITE Postmarket Surveillance Study. 225 subjects were enrolled in the Uphold LITE arm and 64 subjects in the NTR arm. 421 subjects from the AUGS PFD Registry (146 subjects from BSC's Xenform™ 522 study \[NCT01945580\], 69 subjects from Acell's MatriStem® 522 study, and 206 from Coloplast's 522 Restorelle® study) were pulled into the NTR arm for a total of 485 subjects in the NTR cohort and a total of 710 subjects overall.
Secondary efficacy endpoint defined similarly to the primary efficacy endpoint except for the definition of objective success. Objective success for this endpoint is defined as: * Anatomic success in the operated compartment was achieved by: * Anterior segment: No anterior prolapse at or beyond the hymen or POP-Q point Ba \< 0. * Apical segment: The vaginal apex did not descend more than one-half into the vaginal canal (i.e., POP-Q point C \< -1/2 TVL) for multi-compartment prolapse or POP-Q point C \< 0 for single compartment apical prolapse. * Subjective success was achieved if the patient denied symptoms of vaginal bulging per PFDI-20 question 3, answering "no" or "yes" but "Not at all" bothersome (\< 2). * No retreatment for POP: No additional surgical treatment for POP in segment(s) of the vagina treated at the index surgery or no pessary use since index surgery ('treated segment' refers to the target compartments in this study, which are the anterior and apical compartments).
Outcome measures
| Measure |
Uphold Lightweight Vaginal Support System
n=225 Participants
Transvaginal repair with mesh (Uphold LITE)
Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
|
Traditional Native Tissue Repair
n=485 Participants
Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
|
Moderate
Measure of Severity
|
Severe
Measure of Severity
|
|---|---|---|---|---|
|
Secondary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months
Intent to treat
|
188 Participants
|
353 Participants
|
—
|
—
|
|
Secondary Efficacy Endpoint - Number of Participants With Composite Anatomic and Symptomatic Success at 36 Months
Per protocol
|
185 Participants
|
346 Participants
|
—
|
—
|
Adverse Events
Uphold Lightweight Vaginal Support System
Traditional Native Tissue Repair
Serious adverse events
| Measure |
Uphold Lightweight Vaginal Support System
n=225 participants at risk
Transvaginal repair with mesh (Uphold LITE)
Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
|
Traditional Native Tissue Repair
n=485 participants at risk
Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
|
|---|---|---|
|
Cardiac disorders
Cardiac Event- New
|
0.00%
0/225 • 36 Months
|
1.2%
6/485 • Number of events 6 • 36 Months
|
|
Cardiac disorders
Cardiac Event- Worsening
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Constipation - Worsening
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Ileus / Bowel Obstruction
|
0.00%
0/225 • 36 Months
|
0.82%
4/485 • Number of events 4 • 36 Months
|
|
Gastrointestinal disorders
Other, Specify
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
General disorders
Death
|
0.89%
2/225 • Number of events 2 • 36 Months
|
0.00%
0/485 • 36 Months
|
|
General disorders
Fever
|
0.44%
1/225 • Number of events 1 • 36 Months
|
0.00%
0/485 • 36 Months
|
|
General disorders
Infection- Other, Specify Type
|
0.44%
1/225 • Number of events 1 • 36 Months
|
0.00%
0/485 • 36 Months
|
|
Infections and infestations
Infection - Other, specify type
|
0.00%
0/225 • 36 Months
|
0.82%
4/485 • Number of events 6 • 36 Months
|
|
Infections and infestations
Pelvic Infection / Abscess
|
0.00%
0/225 • 36 Months
|
0.41%
2/485 • Number of events 2 • 36 Months
|
|
Infections and infestations
Pulmonary Event, Specify - NEW
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Infections and infestations
Urinary Tract Infection (UTI), Lower
|
0.00%
0/225 • 36 Months
|
0.41%
2/485 • Number of events 2 • 36 Months
|
|
Injury, poisoning and procedural complications
Ureteral Kink / Injury
|
0.44%
1/225 • Number of events 1 • 36 Months
|
0.41%
2/485 • Number of events 2 • 36 Months
|
|
Injury, poisoning and procedural complications
Visceral Organ Injury
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Other, Specify
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Product Issues
Mesh Exposure in Vagina
|
0.44%
1/225 • Number of events 1 • 36 Months
|
0.00%
0/485 • 36 Months
|
|
Renal and urinary disorders
Hematoma - Retropubic
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Mixed Incontinence
|
0.44%
1/225 • Number of events 1 • 36 Months
|
0.00%
0/485 • 36 Months
|
|
Reproductive system and breast disorders
Pelvic Pain - NEW
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Reproductive system and breast disorders
Prolapse
|
0.89%
2/225 • Number of events 2 • 36 Months
|
0.00%
0/485 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Event, Specify - Worsening
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 2 • 36 Months
|
|
Surgical and medical procedures
Other, Specify
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Vascular disorders
Bleeding
|
0.44%
1/225 • Number of events 1 • 36 Months
|
0.00%
0/485 • 36 Months
|
|
Vascular disorders
Bleeding Requiring Blood Transfusion
|
0.44%
1/225 • Number of events 1 • 36 Months
|
0.00%
0/485 • 36 Months
|
|
Vascular disorders
Malignant Hypertension
|
0.44%
1/225 • Number of events 1 • 36 Months
|
0.00%
0/485 • 36 Months
|
|
Vascular disorders
Thrombotic Event
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
Other adverse events
| Measure |
Uphold Lightweight Vaginal Support System
n=225 participants at risk
Transvaginal repair with mesh (Uphold LITE)
Uphold Lightweight Vaginal Support System: Pelvic organ prolapse repair via transvaginal mesh (Uphold LITE)
|
Traditional Native Tissue Repair
n=485 participants at risk
Sacrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
Traditional native tissue repair: Sarcrospinous ligament fixation or uterosacral ligament suspension and/or colporrhaphy
|
|---|---|---|
|
Cardiac disorders
Cardiac Event - NEW
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Cardiac disorders
Cardiac Worsening
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Constipation - NEW
|
1.8%
4/225 • Number of events 4 • 36 Months
|
2.5%
12/485 • Number of events 12 • 36 Months
|
|
Gastrointestinal disorders
Constipation - Worsening
|
0.89%
2/225 • Number of events 2 • 36 Months
|
1.0%
5/485 • Number of events 5 • 36 Months
|
|
Gastrointestinal disorders
Fecal Incontinence - NEW
|
0.00%
0/225 • 36 Months
|
3.7%
18/485 • Number of events 18 • 36 Months
|
|
Gastrointestinal disorders
Fecal Incontinence - Worsening
|
0.00%
0/225 • 36 Months
|
1.2%
6/485 • Number of events 6 • 36 Months
|
|
Gastrointestinal disorders
Hematoma - Retroperitoneal
|
0.89%
2/225 • Number of events 2 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Hemorrhoids
|
0.00%
0/225 • 36 Months
|
0.62%
3/485 • Number of events 3 • 36 Months
|
|
Gastrointestinal disorders
Ileus / Bowel Obstruction
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Gastrointestinal disorders
Nausea
|
0.89%
2/225 • Number of events 2 • 36 Months
|
0.00%
0/485 • 36 Months
|
|
Gastrointestinal disorders
Neuromuscular Disorder, specify type
|
0.00%
0/225 • 36 Months
|
1.6%
8/485 • Number of events 8 • 36 Months
|
|
Gastrointestinal disorders
Other, Specify
|
0.44%
1/225 • Number of events 1 • 36 Months
|
1.4%
7/485 • Number of events 7 • 36 Months
|
|
General disorders
Inflammation
|
0.44%
1/225 • Number of events 1 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
General disorders
Neuromuscular Disorder, specify type
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
General disorders
Other, Specify
|
0.44%
1/225 • Number of events 1 • 36 Months
|
0.41%
2/485 • Number of events 2 • 36 Months
|
|
General disorders
Pain, Other
|
2.2%
5/225 • Number of events 5 • 36 Months
|
0.62%
3/485 • Number of events 3 • 36 Months
|
|
Infections and infestations
Infection - Other, specify type
|
1.8%
4/225 • Number of events 4 • 36 Months
|
1.9%
9/485 • Number of events 10 • 36 Months
|
|
Infections and infestations
Other, Specify
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Infections and infestations
Pelvic Infection / Abscess
|
0.89%
2/225 • Number of events 2 • 36 Months
|
0.62%
3/485 • Number of events 3 • 36 Months
|
|
Infections and infestations
Pulmonary Event, Specify - NEW
|
0.00%
0/225 • 36 Months
|
0.41%
2/485 • Number of events 2 • 36 Months
|
|
Infections and infestations
Upper Respiratory Infection
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Infections and infestations
Urinary Tract Infection (UTI), Lower
|
13.8%
31/225 • Number of events 43 • 36 Months
|
24.3%
118/485 • Number of events 164 • 36 Months
|
|
Infections and infestations
Vaginal Infection
|
1.8%
4/225 • Number of events 4 • 36 Months
|
3.3%
16/485 • Number of events 18 • 36 Months
|
|
Injury, poisoning and procedural complications
Fracture
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 2 • 36 Months
|
|
Injury, poisoning and procedural complications
Other, Specify
|
0.00%
0/225 • 36 Months
|
0.62%
3/485 • Number of events 3 • 36 Months
|
|
Injury, poisoning and procedural complications
Visceral Organ Injury
|
0.00%
0/225 • 36 Months
|
0.41%
2/485 • Number of events 2 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Buttock Pain
|
1.8%
4/225 • Number of events 4 • 36 Months
|
0.41%
2/485 • Number of events 2 • 36 Months
|
|
Musculoskeletal and connective tissue disorders
Neuromuscular Disorder, specify type
|
0.89%
2/225 • Number of events 2 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasia, Non-Pelvic
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Nervous system disorders
Neuromuscular Disorder, specify type
|
4.0%
9/225 • Number of events 9 • 36 Months
|
1.2%
6/485 • Number of events 6 • 36 Months
|
|
Nervous system disorders
Neurovascular Event
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Product Issues
Mesh Exposure in Vagina
|
4.4%
10/225 • Number of events 12 • 36 Months
|
0.00%
0/485 • 36 Months
|
|
Product Issues
Suture Exposure in Vagina
|
0.00%
0/225 • 36 Months
|
3.9%
19/485 • Number of events 20 • 36 Months
|
|
Renal and urinary disorders
Difficulty Emptying Bladder - NEW
|
5.8%
13/225 • Number of events 13 • 36 Months
|
4.9%
24/485 • Number of events 25 • 36 Months
|
|
Renal and urinary disorders
Difficulty Emptying Bladder - Worsening
|
0.44%
1/225 • Number of events 1 • 36 Months
|
0.82%
4/485 • Number of events 4 • 36 Months
|
|
Renal and urinary disorders
Dysuria
|
0.44%
1/225 • Number of events 1 • 36 Months
|
0.82%
4/485 • Number of events 7 • 36 Months
|
|
Renal and urinary disorders
Mixed Incontinence- Worsening
|
0.44%
1/225 • Number of events 1 • 36 Months
|
0.00%
0/485 • 36 Months
|
|
Renal and urinary disorders
Mixed Urinary Incontinence
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Renal and urinary disorders
Other, Specify
|
0.44%
1/225 • Number of events 1 • 36 Months
|
1.0%
5/485 • Number of events 5 • 36 Months
|
|
Renal and urinary disorders
Overactive Bladder
|
2.2%
5/225 • Number of events 5 • 36 Months
|
1.2%
6/485 • Number of events 6 • 36 Months
|
|
Renal and urinary disorders
Stress Incontinence - NEW
|
3.1%
7/225 • Number of events 7 • 36 Months
|
1.2%
6/485 • Number of events 6 • 36 Months
|
|
Renal and urinary disorders
Stress Incontinence - Worsening
|
1.3%
3/225 • Number of events 3 • 36 Months
|
4.3%
21/485 • Number of events 21 • 36 Months
|
|
Renal and urinary disorders
Urge Incontinence - NEW
|
3.6%
8/225 • Number of events 8 • 36 Months
|
1.6%
8/485 • Number of events 8 • 36 Months
|
|
Renal and urinary disorders
Urge Incontinence - Worsening
|
0.44%
1/225 • Number of events 1 • 36 Months
|
5.2%
25/485 • Number of events 26 • 36 Months
|
|
Renal and urinary disorders
Urinary Frequency
|
0.44%
1/225 • Number of events 1 • 36 Months
|
1.2%
6/485 • Number of events 6 • 36 Months
|
|
Renal and urinary disorders
Urinary Urgency
|
0.89%
2/225 • Number of events 2 • 36 Months
|
1.0%
5/485 • Number of events 5 • 36 Months
|
|
Renal and urinary disorders
Weak Urinary Stream
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Reproductive system and breast disorders
Dyspareunia - NEW (De Novo)
|
1.3%
3/225 • Number of events 3 • 36 Months
|
2.3%
11/485 • Number of events 11 • 36 Months
|
|
Reproductive system and breast disorders
Dyspareunia - Worsening
|
0.00%
0/225 • 36 Months
|
0.62%
3/485 • Number of events 3 • 36 Months
|
|
Reproductive system and breast disorders
Hematoma - Vaginal
|
0.44%
1/225 • Number of events 1 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Reproductive system and breast disorders
Other, Specify
|
0.89%
2/225 • Number of events 2 • 36 Months
|
0.82%
4/485 • Number of events 4 • 36 Months
|
|
Reproductive system and breast disorders
Pelvic Pain - New
|
6.2%
14/225 • Number of events 14 • 36 Months
|
8.0%
39/485 • Number of events 41 • 36 Months
|
|
Reproductive system and breast disorders
Pelvic Pain - Worsening
|
0.44%
1/225 • Number of events 1 • 36 Months
|
0.41%
2/485 • Number of events 2 • 36 Months
|
|
Reproductive system and breast disorders
Prolapse
|
8.9%
20/225 • Number of events 20 • 36 Months
|
18.1%
88/485 • Number of events 93 • 36 Months
|
|
Reproductive system and breast disorders
Sensation Of Bulge
|
11.6%
26/225 • Number of events 27 • 36 Months
|
10.9%
53/485 • Number of events 55 • 36 Months
|
|
Reproductive system and breast disorders
Sensation Of Pressure
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Reproductive system and breast disorders
Vaginal Atrophy
|
0.00%
0/225 • 36 Months
|
0.62%
3/485 • Number of events 3 • 36 Months
|
|
Reproductive system and breast disorders
Vaginal Bleeding, De Novo
|
0.00%
0/225 • 36 Months
|
1.9%
9/485 • Number of events 10 • 36 Months
|
|
Reproductive system and breast disorders
Vaginal Discharge, Atypical
|
0.89%
2/225 • Number of events 2 • 36 Months
|
0.62%
3/485 • Number of events 3 • 36 Months
|
|
Reproductive system and breast disorders
Vaginal Scarring
|
0.00%
0/225 • 36 Months
|
0.41%
2/485 • Number of events 2 • 36 Months
|
|
Reproductive system and breast disorders
Vaginal Shortening
|
0.44%
1/225 • Number of events 1 • 36 Months
|
0.00%
0/485 • 36 Months
|
|
Reproductive system and breast disorders
Vaginal Wall Dehiscence
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Reproductive system and breast disorders
Vulvar Itching
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Reproductive system and breast disorders
Vulvar Lesion
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Respiratory, thoracic and mediastinal disorders
Other, Specify
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Skin and subcutaneous tissue disorders
Lichen Sclerosus
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Skin and subcutaneous tissue disorders
Skin Condition
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Skin and subcutaneous tissue disorders
Tissue Granulation
|
0.89%
2/225 • Number of events 2 • 36 Months
|
6.8%
33/485 • Number of events 33 • 36 Months
|
|
Vascular disorders
Bleeding
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Vascular disorders
Hematoma - Other
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
|
Vascular disorders
Other, Specify
|
0.00%
0/225 • 36 Months
|
0.21%
1/485 • Number of events 1 • 36 Months
|
Additional Information
Director, Clinical Operations
Boston Scientific Corporation
Results disclosure agreements
- Principal investigator is a sponsor employee Before publishing, Institution and Investigator shall submit copies of any proposed publication or presentation to Sponsor for review at least sixty (60) days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any Confidential Information or other proprietary information of Sponsor (including trade secrets but not including Results) from the proposed publication or presentation.
- Publication restrictions are in place
Restriction type: OTHER