Trial Outcomes & Findings for Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence (NCT NCT01090739)
NCT ID: NCT01090739
Last Updated: 2016-08-26
Results Overview
The primary endpoint for efficacy is the 14 day bowel diary documenting liquid or solid fecal incontinence episodes. A 50% reduction in the number of FI episodes is considered a treatment responder.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
207 participants
Primary outcome timeframe
12 Months
Results posted on
2016-08-26
Participant Flow
Subject recruitment occurred from July 2010 - December 2012.
Following enrollment (i.e., signing informed consent form), subjects underwent two screening visits to evaluate and confirm eligibility for the TOPAS implant procedures.
Participant milestones
| Measure |
TOPAS
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
|
|---|---|
|
Enrollment
STARTED
|
207
|
|
Enrollment
COMPLETED
|
152
|
|
Enrollment
NOT COMPLETED
|
55
|
|
12 Month Follow-up
STARTED
|
152
|
|
12 Month Follow-up
COMPLETED
|
147
|
|
12 Month Follow-up
NOT COMPLETED
|
5
|
|
24 Month Follow-up
STARTED
|
147
|
|
24 Month Follow-up
COMPLETED
|
138
|
|
24 Month Follow-up
NOT COMPLETED
|
9
|
|
36 Month Follow-up
STARTED
|
138
|
|
36 Month Follow-up
COMPLETED
|
115
|
|
36 Month Follow-up
NOT COMPLETED
|
23
|
Reasons for withdrawal
| Measure |
TOPAS
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
|
|---|---|
|
Enrollment
Withdrawal by Subject
|
24
|
|
Enrollment
Protocol Violation
|
14
|
|
Enrollment
Lost to Follow-up
|
5
|
|
Enrollment
Physician Decision
|
5
|
|
Enrollment
Sponsor termination of site
|
4
|
|
Enrollment
Study implant limit reached
|
2
|
|
Enrollment
Adverse Event
|
1
|
|
12 Month Follow-up
Withdrawal by Subject
|
2
|
|
12 Month Follow-up
Lost to Follow-up
|
1
|
|
12 Month Follow-up
Physician Decision
|
1
|
|
12 Month Follow-up
Death
|
1
|
|
24 Month Follow-up
Withdrawal by Subject
|
7
|
|
24 Month Follow-up
Lost to Follow-up
|
1
|
|
24 Month Follow-up
Death
|
1
|
|
36 Month Follow-up
Withdrawal by Subject
|
6
|
|
36 Month Follow-up
Visit still pending
|
17
|
Baseline Characteristics
Clinical Study to Investigate the Effectiveness of the TOPAS System to Treat Fecal Incontinence
Baseline characteristics by cohort
| Measure |
TOPAS
n=152 Participants
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
|
|---|---|
|
Age, Continuous
|
59.6 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
|
Sex/Gender, Customized
Women
|
152 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
137 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
10 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latina
|
3 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
152 participants
n=5 Participants
|
|
Obstetric History - Gravidity
|
3.0 number
STANDARD_DEVIATION 1.8 • n=5 Participants
|
|
Obstetric History - Parity
|
2.6 number
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Obstetric History - # of Vaginal Deliveries
|
2.4 number
STANDARD_DEVIATION 1.5 • n=5 Participants
|
|
Obstetric History - # of Caesarean deliveries
|
0.1 number
STANDARD_DEVIATION 0.5 • n=5 Participants
|
|
Menopausal Status
Pre-menopausal
|
20 participants
n=5 Participants
|
|
Menopausal Status
Peri-menopausal
|
6 participants
n=5 Participants
|
|
Menopausal Status
Post-menopausal
|
126 participants
n=5 Participants
|
|
Concomitant Use
# Smoked within past 6 months
|
8 participants
n=5 Participants
|
|
Concomitant Use
# Caffeine use on a regular basis
|
102 participants
n=5 Participants
|
|
Concomitant Use
# Rgular laxative use within past 5 years
|
18 participants
n=5 Participants
|
|
Duration of Fecal Incontinence
|
110.0 months
STANDARD_DEVIATION 113.5 • n=5 Participants
|
|
Etiology of Fecal Incontinence
Anorectal trauma
|
6 participants
n=5 Participants
|
|
Etiology of Fecal Incontinence
Obstetric trauma
|
87 participants
n=5 Participants
|
|
Etiology of Fecal Incontinence
Idiopathic/unknown
|
62 participants
n=5 Participants
|
|
Etiology of Fecal Incontinence
Other
|
4 participants
n=5 Participants
|
|
Rectal soft tissue scarring
Present
|
26 participants
n=5 Participants
|
|
Rectal soft tissue scarring
Absent
|
126 participants
n=5 Participants
|
|
Baseline Medical History
Previous hysterectomy / oophorectomy
|
74 participants
n=5 Participants
|
|
Baseline Medical History
Previous prolapse / UI repair
|
70 participants
n=5 Participants
|
|
Baseline Medical History
Gastrointestional reflux disease
|
65 participants
n=5 Participants
|
|
Baseline Medical History
Hypertension
|
60 participants
n=5 Participants
|
|
Baseline Medical History
Depressive disorder
|
56 participants
n=5 Participants
|
|
Baseline Medical History
Systemic pain
|
55 participants
n=5 Participants
|
|
Baseline Medical History
Hyperlipidemia
|
53 participants
n=5 Participants
|
|
Baseline Medical History
Pelvic area pain
|
52 participants
n=5 Participants
|
|
Baseline Medical History
Diverticulitis
|
41 participants
n=5 Participants
|
|
Baseline Medical History
Urinary incontinence
|
39 participants
n=5 Participants
|
|
Baseline Medical History
Hypothroid
|
38 participants
n=5 Participants
|
|
Baseline Medical History
Previous cholecystectomy
|
38 participants
n=5 Participants
|
|
Baseline Medical History
Hemorrhoids
|
36 participants
n=5 Participants
|
|
Baseline Medical History
Irritable bowel syndrome
|
31 participants
n=5 Participants
|
|
Baseline Medical History
Previous anal sphincter repair
|
31 participants
n=5 Participants
|
|
Baseline Medical History
Headaches
|
29 participants
n=5 Participants
|
|
Baseline Medical History
Vaginal atrophy
|
23 participants
n=5 Participants
|
|
Baseline Medical History
Diabetes
|
19 participants
n=5 Participants
|
|
Baseline Medical History
Vaginal prolapse
|
8 participants
n=5 Participants
|
|
Baseline Medical History
Rectal prolapse
|
6 participants
n=5 Participants
|
|
Baseline Medical History
Gallstones
|
2 participants
n=5 Participants
|
|
Baseline Fecal Incontinence Medication
Opioid-receptor agents
|
30 participants
n=5 Participants
|
|
Baseline Fecal Incontinence Medication
Bulking agents
|
22 participants
n=5 Participants
|
|
Baseline Fecal Incontinence Medication
Osmotic laxatives
|
8 participants
n=5 Participants
|
|
Baseline Fecal Incontinence Medication
Anti-cholinergic agents
|
6 participants
n=5 Participants
|
|
Baseline Fecal Incontinence Medication
Other meds
|
5 participants
n=5 Participants
|
|
Baseline Fecal Incontinence Medication
Bile acid sequestrants
|
3 participants
n=5 Participants
|
|
Failed Fecal Incontinence Conservative Therapy
Diet modification and medication
|
22 participants
n=5 Participants
|
|
Failed Fecal Incontinence Conservative Therapy
Diet modification and pelvic floor muscle training
|
49 participants
n=5 Participants
|
|
Failed Fecal Incontinence Conservative Therapy
Medication and pelvic floor muscle training
|
20 participants
n=5 Participants
|
|
Failed Fecal Incontinence Conservative Therapy
Diet, medication and pelvic floor training
|
61 participants
n=5 Participants
|
|
Hemorrhoids
Present
|
34 participants
n=5 Participants
|
|
Hemorrhoids
Absent
|
118 participants
n=5 Participants
|
|
Anal Resting Tone
Present
|
141 participants
n=5 Participants
|
|
Anal Resting Tone
Absent
|
11 participants
n=5 Participants
|
|
Anorectal Manometry - Pressures
Mean Maximum Resting Pressure
|
31.5 mmHg
STANDARD_DEVIATION 21.9 • n=5 Participants
|
|
Anorectal Manometry - Pressures
Mean Maximum Squeeze Pressure
|
60.1 mmHg
STANDARD_DEVIATION 42.6 • n=5 Participants
|
|
Anorectal Manometry - Volumes
First sensation volume
|
43.1 cc
STANDARD_DEVIATION 30.9 • n=5 Participants
|
|
Anorectal Manometry - Volumes
Maximum tolerated volume
|
124.8 cc
STANDARD_DEVIATION 61.9 • n=5 Participants
|
|
External Anal Sphincter Defects
Present
|
79 participants
n=5 Participants
|
|
External Anal Sphincter Defects
Absent
|
73 participants
n=5 Participants
|
|
Internal Anal Sphincter Defects
Present
|
42 participants
n=5 Participants
|
|
Internal Anal Sphincter Defects
Absent
|
110 participants
n=5 Participants
|
|
External Anal Sphincter Defect Extent
|
95.3 degrees
STANDARD_DEVIATION 45.0 • n=5 Participants
|
|
Internal Anal Sphincter Defect Extent
|
110.0 degrees
STANDARD_DEVIATION 53.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: All subjects implanted
The primary endpoint for efficacy is the 14 day bowel diary documenting liquid or solid fecal incontinence episodes. A 50% reduction in the number of FI episodes is considered a treatment responder.
Outcome measures
| Measure |
TOPAS
n=152 Participants
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
|
|---|---|
|
Percentage of Responders
|
69.1 percentage of treatment responders
Interval 61.1 to 76.3
|
SECONDARY outcome
Timeframe: 36 Month Follow-up VisitPopulation: All subjects implanted
Number of fecal incontinence episodes in a 14 day period
Outcome measures
| Measure |
TOPAS
n=152 Participants
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
|
|---|---|
|
Change in Fecal Incontinence Episodes
Baseline
|
18 fecal incontinent episodes/14 days
Interval 4.0 to 81.0
|
|
Change in Fecal Incontinence Episodes
3 Months
|
5 fecal incontinent episodes/14 days
Interval 0.0 to 94.0
|
|
Change in Fecal Incontinence Episodes
6 Months
|
5 fecal incontinent episodes/14 days
Interval 0.0 to 67.0
|
|
Change in Fecal Incontinence Episodes
12 Months
|
5 fecal incontinent episodes/14 days
Interval 0.0 to 80.0
|
|
Change in Fecal Incontinence Episodes
24 Months
|
5 fecal incontinent episodes/14 days
Interval 0.0 to 73.0
|
|
Change in Fecal Incontinence Episodes
36 Months
|
5 fecal incontinent episodes/14 days
Interval 0.0 to 52.0
|
SECONDARY outcome
Timeframe: 36 Month Follow-up VisitPopulation: All subjects implanted
Number of fecal incontinence days in a 14 day period
Outcome measures
| Measure |
TOPAS
n=152 Participants
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
|
|---|---|
|
Change in Fecal Incontinence Days
Baseline
|
10 fecal incontinent days/14 days
Interval 3.0 to 14.0
|
|
Change in Fecal Incontinence Days
3 Months
|
4 fecal incontinent days/14 days
Interval 0.0 to 14.0
|
|
Change in Fecal Incontinence Days
6 Months
|
4 fecal incontinent days/14 days
Interval 0.0 to 14.0
|
|
Change in Fecal Incontinence Days
12 Months
|
4 fecal incontinent days/14 days
Interval 0.0 to 14.0
|
|
Change in Fecal Incontinence Days
24 Months
|
4 fecal incontinent days/14 days
Interval 0.0 to 14.0
|
|
Change in Fecal Incontinence Days
36 Months
|
4 fecal incontinent days/14 days
Interval 0.0 to 14.0
|
SECONDARY outcome
Timeframe: 36 Month Follow-up VisitPopulation: All subjects implanted
Number of urge fecal incontinence episodes in a 14 day period
Outcome measures
| Measure |
TOPAS
n=152 Participants
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
|
|---|---|
|
Change in Urge Fecal Incontinence Episodes
36 Months
|
0 urge fecal incontinent episodes/14 days
Interval 0.0 to 34.0
|
|
Change in Urge Fecal Incontinence Episodes
Baseline
|
4 urge fecal incontinent episodes/14 days
Interval 0.0 to 52.0
|
|
Change in Urge Fecal Incontinence Episodes
3 Months
|
0 urge fecal incontinent episodes/14 days
Interval 0.0 to 16.0
|
|
Change in Urge Fecal Incontinence Episodes
6 Months
|
0 urge fecal incontinent episodes/14 days
Interval 0.0 to 18.0
|
|
Change in Urge Fecal Incontinence Episodes
12 Months
|
0 urge fecal incontinent episodes/14 days
Interval 0.0 to 29.0
|
|
Change in Urge Fecal Incontinence Episodes
24 Months
|
0 urge fecal incontinent episodes/14 days
Interval 0.0 to 39.0
|
SECONDARY outcome
Timeframe: 36 Month Follow-up VisitPopulation: All subjects implanted
Wexner Symptom Severity Score for fecal incontinence (also known as the Cleveland Clinic Incontinence Score) as described by Jorge and Wexner, 1993 (Jorge JM, Wexner SD. Etiology and management of fecal incontinence. Dis Colon Rectum. 1993 Jan;36(1):77-97). Measured on a 0-20 scale with lower scores equal to less fecal incontinence.
Outcome measures
| Measure |
TOPAS
n=152 Participants
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
|
|---|---|
|
Change in Wexner Symptom Severity Score
Baseline
|
13.9 units on a scale
Standard Deviation 2.7
|
|
Change in Wexner Symptom Severity Score
3 Months
|
9.4 units on a scale
Standard Deviation 4.3
|
|
Change in Wexner Symptom Severity Score
6 Months
|
9.8 units on a scale
Standard Deviation 4.4
|
|
Change in Wexner Symptom Severity Score
12 Months
|
9.6 units on a scale
Standard Deviation 3.9
|
|
Change in Wexner Symptom Severity Score
24 Months
|
9.5 units on a scale
Standard Deviation 4.2
|
|
Change in Wexner Symptom Severity Score
36 Months
|
9.4 units on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: 36 Month Follow-up VisitPopulation: All subjects implanted
Fecal Incontinence Quality of Life Score as described by Rockwood et al., 2000 (Rockwood TH, Church JM, Fleshman JW, Kane RL, Mavrantonis C, Thorson AG, Wexner SD, Bliss D, Lowry AC. Fecal Incontinence Quality of Life Scale: quality of life instrument for patients with fecal incontinence. Dis Colon Rectum. 2000 Jan;43(1):9-16; discussion 16-7). Four domains of lifestyle, coping, depression, and embarrassment. Measured on a 0-4 scale with higher scores equal to better quality of life.
Outcome measures
| Measure |
TOPAS
n=152 Participants
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
|
|---|---|
|
Change in Fecal Incontinence Quality of Life Score
Lifestyle - Baseline
|
2.6 units on a scale
Standard Deviation 0.8
|
|
Change in Fecal Incontinence Quality of Life Score
Lifestyle - 3 Months
|
3.3 units on a scale
Standard Deviation 0.7
|
|
Change in Fecal Incontinence Quality of Life Score
Lifestyle - 6 Months
|
3.3 units on a scale
Standard Deviation 0.7
|
|
Change in Fecal Incontinence Quality of Life Score
Lifestyle - 12 Months
|
3.4 units on a scale
Standard Deviation 0.7
|
|
Change in Fecal Incontinence Quality of Life Score
Lifestyle - 24 Months
|
3.4 units on a scale
Standard Deviation 0.7
|
|
Change in Fecal Incontinence Quality of Life Score
Lifestyle - 36 Months
|
3.4 units on a scale
Standard Deviation 0.7
|
|
Change in Fecal Incontinence Quality of Life Score
Coping - Baseline
|
1.7 units on a scale
Standard Deviation 0.6
|
|
Change in Fecal Incontinence Quality of Life Score
Coping - 3 Months
|
2.6 units on a scale
Standard Deviation 0.8
|
|
Change in Fecal Incontinence Quality of Life Score
Coping - 6 Months
|
2.6 units on a scale
Standard Deviation 0.9
|
|
Change in Fecal Incontinence Quality of Life Score
Coping - 12 Months
|
2.7 units on a scale
Standard Deviation 0.9
|
|
Change in Fecal Incontinence Quality of Life Score
Coping - 24 Months
|
2.7 units on a scale
Standard Deviation 0.9
|
|
Change in Fecal Incontinence Quality of Life Score
Coping - 36 Months
|
2.7 units on a scale
Standard Deviation 0.9
|
|
Change in Fecal Incontinence Quality of Life Score
Depression - Baseline
|
2.4 units on a scale
Standard Deviation 0.6
|
|
Change in Fecal Incontinence Quality of Life Score
Depression - 3 Months
|
3.0 units on a scale
Standard Deviation 0.7
|
|
Change in Fecal Incontinence Quality of Life Score
Depression - 6 Months
|
3.1 units on a scale
Standard Deviation 0.7
|
|
Change in Fecal Incontinence Quality of Life Score
Depression - 12 Months
|
3.1 units on a scale
Standard Deviation 0.7
|
|
Change in Fecal Incontinence Quality of Life Score
Depression - 24 Months
|
3.1 units on a scale
Standard Deviation 0.7
|
|
Change in Fecal Incontinence Quality of Life Score
Depression - 36 Months
|
3.2 units on a scale
Standard Deviation 0.7
|
|
Change in Fecal Incontinence Quality of Life Score
Embarrassment - Baseline
|
1.6 units on a scale
Standard Deviation 0.6
|
|
Change in Fecal Incontinence Quality of Life Score
Embarrassment - 3 Months
|
2.5 units on a scale
Standard Deviation 0.9
|
|
Change in Fecal Incontinence Quality of Life Score
Embarrassment - 6 Months
|
2.6 units on a scale
Standard Deviation 1.0
|
|
Change in Fecal Incontinence Quality of Life Score
Embarrassment - 12 Months
|
2.7 units on a scale
Standard Deviation 0.9
|
|
Change in Fecal Incontinence Quality of Life Score
Embarrassment - 24 Months
|
2.7 units on a scale
Standard Deviation 0.9
|
|
Change in Fecal Incontinence Quality of Life Score
Embarrassment - 36 Months
|
2.7 units on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: 36 Month Follow-up VisitPopulation: All subjects implanted
Short-form version of the Pelvic Floor Distress Inventory (PFDI-20) as described by Barber et al., 2005 (Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7. Am J Obstet Gynecol. 2005 Jul;193(1):103-13). The short-form version of the Pelvic Floor Distress Inventory has a total of 20 questions and 3 scales (Urinary Distress Inventory, Pelvic Organ Prolapse Distress Inventory, and Colorectal-Anal Distress Inventory). Total PFDI score measured on a 0-300 scale with higher scores equal to greater pelvic floor distress. As with the Total PFDI Score, higher subscale scores equal greater pelvic floor distress, on a 0-100 scale.
Outcome measures
| Measure |
TOPAS
n=152 Participants
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
|
|---|---|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
POP Subscale - 24 Months
|
12.1 units on a scale
Standard Deviation 13.8
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
POP Subscale - 36 Months
|
13.8 units on a scale
Standard Deviation 16.9
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Total PFDI Score - Baseline
|
104.1 units on a scale
Standard Deviation 47.4
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Total PFDI Score - 3 Months
|
69.7 units on a scale
Standard Deviation 43.1
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Total PFDI Score - 6 Months
|
68.8 units on a scale
Standard Deviation 45.9
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Total PFDI Score - 12 Months
|
66.7 units on a scale
Standard Deviation 43.4
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Total PFDI Score - 24 Months
|
65.7 units on a scale
Standard Deviation 43.9
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Total PFDI Score - 36 Months
|
70.3 units on a scale
Standard Deviation 51.2
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Colorectal-Anal Subscale - Baseline
|
54.8 units on a scale
Standard Deviation 16.2
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Colorectal-Anal Subscale - 3 Months
|
33.3 units on a scale
Standard Deviation 17.7
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Colorectal-Anal Subscale - 6 Months
|
33.0 units on a scale
Standard Deviation 19.8
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Colorectal-Anal Subscale - 12 Months
|
32.1 units on a scale
Standard Deviation 19.2
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Colorectal-Anal Subscale - 24 Months
|
31.5 units on a scale
Standard Deviation 19.7
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Colorectal-Anal Subscale - 36 Months
|
33.5 units on a scale
Standard Deviation 21.0
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Urinary Subscale - Baseline
|
27.2 units on a scale
Standard Deviation 25.1
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Urinary Subscale - 3 Months
|
21.4 units on a scale
Standard Deviation 21.5
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Urinary Subscale - 6 Months
|
21.4 units on a scale
Standard Deviation 22.7
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Urinary Subscale - 12 Months
|
21.5 units on a scale
Standard Deviation 21.9
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Urinary Subscale - 24 Months
|
22.2 units on a scale
Standard Deviation 22.1
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
Urinary Subscale - 36 Months
|
22.6 units on a scale
Standard Deviation 23.0
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
POP Subscale - Baseline
|
21.9 units on a scale
Standard Deviation 19.5
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
POP Subscale - 3 Months
|
14.9 units on a scale
Standard Deviation 15.6
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
POP Subscale - 6 Months
|
14.2 units on a scale
Standard Deviation 14.9
|
|
Change in Pelvic Floor Distress Inventory (PFDI-20) Scores
POP Subscale - 12 Months
|
12.8 units on a scale
Standard Deviation 13.9
|
SECONDARY outcome
Timeframe: 36 Month Follow-up VisitPopulation: All subjects implanted
Short-form version of the Pelvic Floor Impact Questionnaire (PFIQ-7) as described by Barber et al., 2005 (Barber MD, Walters MD, Bump RC. Short forms of two condition-specific quality-of-life questionnaires for women with pelvic floor disorders (PFDI-20 and PFIQ-7. Am J Obstet Gynecol. 2005 Jul;193(1):103-13). The short-form version of the Pelvic Floor Impact Questionnaire has a total of 7 questions and 3 scales (Urinary Impact, Pelvic Organ Prolapse Impact, and Colorectal-Anal Impact). Total PFIQ score measured on a 0-300 scale with higher scores equal to greater pelvic floor impact. Subscales scored on 0-100 scale and the higher the score the greater pelvic floor impact, exactly like the Total PFIQ score.
Outcome measures
| Measure |
TOPAS
n=152 Participants
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
|
|---|---|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Total PDFI Score - Baseline
|
79.6 units on a scale
Standard Deviation 52.3
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Total PDFI Score - 3 Months
|
41.0 units on a scale
Standard Deviation 43.5
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Total PDFI Score - 6 Months
|
39.6 units on a scale
Standard Deviation 48.4
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Total PDFI Score - 12 Months
|
37.9 units on a scale
Standard Deviation 43.5
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Total PDFI Score - 24 Months
|
35.2 units on a scale
Standard Deviation 45.5
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Total PDFI Score - 36 Months
|
38.5 units on a scale
Standard Deviation 48.5
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Colorectal-Anal Subscale - Baseline
|
51.7 units on a scale
Standard Deviation 25.5
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Colorectal-Anal Subscale - 3 Months
|
23.1 units on a scale
Standard Deviation 22.7
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Colorectal-Anal Subscale - 6 Months
|
23.3 units on a scale
Standard Deviation 24.1
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Colorectal-Anal Subscale - 12 Months
|
21.7 units on a scale
Standard Deviation 22.6
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Colorectal-Anal Subscale - 24 Months
|
20.4 units on a scale
Standard Deviation 22.9
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Colorectal-Anal Subscale - 36 Months
|
20.9 units on a scale
Standard Deviation 22.1
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Urinary Subscale - Baseline
|
18.5 units on a scale
Standard Deviation 23.6
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Urinary Subscale - 3 Months
|
12.7 units on a scale
Standard Deviation 19.8
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Urinary Subscale - 6 Months
|
10.8 units on a scale
Standard Deviation 18.3
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Urinary Subscale - 12 Months
|
11.3 units on a scale
Standard Deviation 18.1
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Urinary Subscale - 24 Months
|
10.4 units on a scale
Standard Deviation 17.7
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
Urinary Subscale - 36 Months
|
11.8 units on a scale
Standard Deviation 19.6
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
POP Subscale - Baseline
|
9.8 units on a scale
Standard Deviation 19.5
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
POP Subscale - 3 Months
|
5.2 units on a scale
Standard Deviation 11.8
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
POP Subscale - 6 Months
|
5.8 units on a scale
Standard Deviation 16.3
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
POP Subscale - 12 Months
|
4.8 units on a scale
Standard Deviation 12.7
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
POP Subscale - 24 Months
|
4.5 units on a scale
Standard Deviation 13.9
|
|
Change in Pelvic Floor Impact Questionnaire (PFIQ-7) Scores
POP Subscale - 36 Months
|
5.8 units on a scale
Standard Deviation 14.5
|
SECONDARY outcome
Timeframe: 36 Month Follow-up VisitPopulation: All subjects implanted
Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12) as described by Rogers RG, Coates KW, Kammerer-Doak D, Khalsa S, Qualls C. A short form of the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). Int Urogynecol J Pelvic Floor Dysfunct. 2003 Aug;14(3):164-8; discussion 168. Measured on a 0-48 scale with higher scores equal to better sexual function.
Outcome measures
| Measure |
TOPAS
n=152 Participants
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
|
|---|---|
|
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
Baseline
|
32.2 units on a scale
Standard Deviation 6.7
|
|
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
3 Months
|
35.1 units on a scale
Standard Deviation 6.1
|
|
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
6 Months
|
35.0 units on a scale
Standard Deviation 6.9
|
|
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
12 Months
|
34.6 units on a scale
Standard Deviation 7.1
|
|
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
24 Months
|
33.9 units on a scale
Standard Deviation 7.9
|
|
Change in Pelvic Organ Prolapse/Urinary Incontinence Sexual Function Questionnaire (PISQ-12)
36 Months
|
35.1 units on a scale
Standard Deviation 7.8
|
SECONDARY outcome
Timeframe: 12 Month Follow-up VisitPopulation: All subjects implanted at the time the NPPS was implemented in the study
Numeric Pelvic Pain Scale (NPPS) adapted from McCafferty M, Pasero C. Pain: Clinical Manual. 2nd ed. Philadelphia: Mosby Inc.; 1999. Chapter 3, Assessment Tools; p. 58-75. The NPPS is scored on a 0-10 scale with higher scores indicating more severe pain. Since the NPPS was introduced later in the study, earlier implanted subjects did not have the baseline NPPS score and a change from baseline could not be calculated.
Outcome measures
| Measure |
TOPAS
n=103 Participants
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
|
|---|---|
|
Change in Numeric Pelvic Pain Scale (NPPS)
Baseline
|
0.8 units on a scale
Standard Deviation 1.7
|
|
Change in Numeric Pelvic Pain Scale (NPPS)
Procedure
|
3.2 units on a scale
Standard Deviation 2.5
|
|
Change in Numeric Pelvic Pain Scale (NPPS)
Acute Follow-up
|
1.0 units on a scale
Standard Deviation 1.9
|
|
Change in Numeric Pelvic Pain Scale (NPPS)
3 Months
|
0.4 units on a scale
Standard Deviation 1.1
|
|
Change in Numeric Pelvic Pain Scale (NPPS)
6 Months
|
0.7 units on a scale
Standard Deviation 1.8
|
|
Change in Numeric Pelvic Pain Scale (NPPS)
12 Months
|
0.6 units on a scale
Standard Deviation 1.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 Month Follow-up VisitPopulation: All implanted subjects
The SSQ-8 is an 8 item questionnaire to assess subject surgical satisfaction as described by Murphy M, Sternschuss G, Haff R, van Raalte H, Saltz S, Lucente V. Quality of life and surgical satisfaction after vaginal reconstructive vs. obliterative surgery for the treatment of advanced pelvic organ prolapse. Am J Obstet Gynecol. 2008 May;198(5):573.e1-7. The SSQ-8 was collected as an optional one-time assessment from implanted subjects between the 3 and 36 month visits. Scale is scored on 0-100 with higher scores are better
Outcome measures
| Measure |
TOPAS
n=86 Participants
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
|
|---|---|
|
Change in the Haff Surgical Satisfaction Questionnaire (SSQ-8)
|
79.4 units on a scale
Standard Deviation 22.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 Month Follow-up VisitPopulation: All implanted subjects
Change in health resource usage using sponsor-created questionnaire: # days in hospital due to FI
Outcome measures
| Measure |
TOPAS
n=152 Participants
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
|
|---|---|
|
Change in Health Resource Usage: # Pads Per Day Subject Took for FI
# pads per day subject took for FI - Baseline
|
2.4 pads per day
Standard Deviation 2.1
|
|
Change in Health Resource Usage: # Pads Per Day Subject Took for FI
# per day subject took for FI - 12 Months
|
1.4 pads per day
Standard Deviation 1.8
|
|
Change in Health Resource Usage: # Pads Per Day Subject Took for FI
# pads per day subject took for FI - 24 Months
|
1.1 pads per day
Standard Deviation 1.5
|
|
Change in Health Resource Usage: # Pads Per Day Subject Took for FI
# pads per day subject took for FI - 36 Months
|
1.2 pads per day
Standard Deviation 1.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 Month Follow-up VisitPopulation: All implanted subjects
Change in health resource usage using sponsor-created questionnaire
Outcome measures
| Measure |
TOPAS
n=152 Participants
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
|
|---|---|
|
Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI
# days in hospital due to FI - Baseline
|
0.1 days
Standard Deviation 0.6
|
|
Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI
# days in hospital due to FI - 12 Months
|
0.1 days
Standard Deviation 0.5
|
|
Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI
# days in hospital due to FI - 24 Months
|
0.0 days
Standard Deviation 0.1
|
|
Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI
# days in hospital due to FI - 36 Months
|
0.0 days
Standard Deviation 0.0
|
|
Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI
# days took off work due to FI - Baseline
|
6.4 days
Standard Deviation 34.0
|
|
Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI
# days took off work due to FI - 12 Months
|
1.3 days
Standard Deviation 9.9
|
|
Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI
# days took off work due to FI - 24 Months
|
4.5 days
Standard Deviation 35.4
|
|
Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI
# days took off work due to FI - 36 Months
|
0.9 days
Standard Deviation 9.5
|
|
Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI
# days others took off work - Baseline
|
0.2 days
Standard Deviation 1.3
|
|
Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI
# days others took off work - 12 Months
|
0.0 days
Standard Deviation 0.0
|
|
Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI
# days others took off work - 24 Months
|
0.0 days
Standard Deviation 0.3
|
|
Change in Health Resource Usage: # Days in Hospital, Took Off Work, or Others Took Off Work Due to FI
# days others took off work - 36 Months
|
0.0 days
Standard Deviation 0.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 36 Month Follow-up VisitPopulation: All implanted subjects
Change in health resource usage using sponsor-created questionnaire
Outcome measures
| Measure |
TOPAS
n=152 Participants
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
|
|---|---|
|
Change in Health Resource Usage: # Physician Visits Due to FI
# physician visits due to FI - Baseline
|
5.0 physician visits
Standard Deviation 7.6
|
|
Change in Health Resource Usage: # Physician Visits Due to FI
# physician visits due to FI - 12 Months
|
0.4 physician visits
Standard Deviation 1.4
|
|
Change in Health Resource Usage: # Physician Visits Due to FI
# physician visits due to FI - 24 Months
|
0.5 physician visits
Standard Deviation 1.8
|
|
Change in Health Resource Usage: # Physician Visits Due to FI
# physician visits due to FI - 36 Months
|
0.3 physician visits
Standard Deviation 1.1
|
Adverse Events
TOPAS
Serious events: 8 serious events
Other events: 72 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TOPAS
n=152 participants at risk
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
|
|---|---|
|
Musculoskeletal and connective tissue disorders
Pain/discomfort - buttock
|
0.66%
1/152 • Number of events 1 • AEs collected for each subject from the time of enrollment (signing informed consent form) through duration of follow-up visits (up to 60 months). The mean follow-up period for all subjects was 40.2 months (509 subject years).
An independent Adverse Event Adjudication Committee (three physicians: Colorectal, Gastroenterology, Urogynecology) reviewed all AEs and death data and assigned or verified correct assignment of codes, event seriousness, relatedness to the study device and/or procedure. All AEs listed here are device- and/or procedure-related only.
|
|
Reproductive system and breast disorders
Worsening Pelvic Organ Prolapse
|
0.66%
1/152 • Number of events 1 • AEs collected for each subject from the time of enrollment (signing informed consent form) through duration of follow-up visits (up to 60 months). The mean follow-up period for all subjects was 40.2 months (509 subject years).
An independent Adverse Event Adjudication Committee (three physicians: Colorectal, Gastroenterology, Urogynecology) reviewed all AEs and death data and assigned or verified correct assignment of codes, event seriousness, relatedness to the study device and/or procedure. All AEs listed here are device- and/or procedure-related only.
|
|
Reproductive system and breast disorders
De novo pelvic organ prolapse
|
0.66%
1/152 • Number of events 1 • AEs collected for each subject from the time of enrollment (signing informed consent form) through duration of follow-up visits (up to 60 months). The mean follow-up period for all subjects was 40.2 months (509 subject years).
An independent Adverse Event Adjudication Committee (three physicians: Colorectal, Gastroenterology, Urogynecology) reviewed all AEs and death data and assigned or verified correct assignment of codes, event seriousness, relatedness to the study device and/or procedure. All AEs listed here are device- and/or procedure-related only.
|
|
Psychiatric disorders
Exacerbated post traumatic stress disorder
|
0.66%
1/152 • Number of events 1 • AEs collected for each subject from the time of enrollment (signing informed consent form) through duration of follow-up visits (up to 60 months). The mean follow-up period for all subjects was 40.2 months (509 subject years).
An independent Adverse Event Adjudication Committee (three physicians: Colorectal, Gastroenterology, Urogynecology) reviewed all AEs and death data and assigned or verified correct assignment of codes, event seriousness, relatedness to the study device and/or procedure. All AEs listed here are device- and/or procedure-related only.
|
|
Vascular disorders
Deep vein thrombosis
|
0.66%
1/152 • Number of events 1 • AEs collected for each subject from the time of enrollment (signing informed consent form) through duration of follow-up visits (up to 60 months). The mean follow-up period for all subjects was 40.2 months (509 subject years).
An independent Adverse Event Adjudication Committee (three physicians: Colorectal, Gastroenterology, Urogynecology) reviewed all AEs and death data and assigned or verified correct assignment of codes, event seriousness, relatedness to the study device and/or procedure. All AEs listed here are device- and/or procedure-related only.
|
|
Respiratory, thoracic and mediastinal disorders
Worsening chronic obstructive pulmonary disease
|
0.66%
1/152 • Number of events 1 • AEs collected for each subject from the time of enrollment (signing informed consent form) through duration of follow-up visits (up to 60 months). The mean follow-up period for all subjects was 40.2 months (509 subject years).
An independent Adverse Event Adjudication Committee (three physicians: Colorectal, Gastroenterology, Urogynecology) reviewed all AEs and death data and assigned or verified correct assignment of codes, event seriousness, relatedness to the study device and/or procedure. All AEs listed here are device- and/or procedure-related only.
|
|
Reproductive system and breast disorders
De novo rectal prolapse
|
0.66%
1/152 • Number of events 1 • AEs collected for each subject from the time of enrollment (signing informed consent form) through duration of follow-up visits (up to 60 months). The mean follow-up period for all subjects was 40.2 months (509 subject years).
An independent Adverse Event Adjudication Committee (three physicians: Colorectal, Gastroenterology, Urogynecology) reviewed all AEs and death data and assigned or verified correct assignment of codes, event seriousness, relatedness to the study device and/or procedure. All AEs listed here are device- and/or procedure-related only.
|
|
Infections and infestations
Methicillin-resistant staphylococcus aureus infection
|
0.66%
1/152 • Number of events 1 • AEs collected for each subject from the time of enrollment (signing informed consent form) through duration of follow-up visits (up to 60 months). The mean follow-up period for all subjects was 40.2 months (509 subject years).
An independent Adverse Event Adjudication Committee (three physicians: Colorectal, Gastroenterology, Urogynecology) reviewed all AEs and death data and assigned or verified correct assignment of codes, event seriousness, relatedness to the study device and/or procedure. All AEs listed here are device- and/or procedure-related only.
|
Other adverse events
| Measure |
TOPAS
n=152 participants at risk
TOPAS Treatment for Fecal Incontinence: The TOPAS Treatment for Fecal Incontinence is implanted using a minimally invasive trans-obturator approach; two needle passers deliver the sling assembly. Two small posterior incisions facilitate the post-anal placement of the mesh.
|
|---|---|
|
Reproductive system and breast disorders
Pelvic area pain
|
28.3%
43/152 • Number of events 50 • AEs collected for each subject from the time of enrollment (signing informed consent form) through duration of follow-up visits (up to 60 months). The mean follow-up period for all subjects was 40.2 months (509 subject years).
An independent Adverse Event Adjudication Committee (three physicians: Colorectal, Gastroenterology, Urogynecology) reviewed all AEs and death data and assigned or verified correct assignment of codes, event seriousness, relatedness to the study device and/or procedure. All AEs listed here are device- and/or procedure-related only.
|
|
Infections and infestations
Infection
|
14.5%
22/152 • Number of events 25 • AEs collected for each subject from the time of enrollment (signing informed consent form) through duration of follow-up visits (up to 60 months). The mean follow-up period for all subjects was 40.2 months (509 subject years).
An independent Adverse Event Adjudication Committee (three physicians: Colorectal, Gastroenterology, Urogynecology) reviewed all AEs and death data and assigned or verified correct assignment of codes, event seriousness, relatedness to the study device and/or procedure. All AEs listed here are device- and/or procedure-related only.
|
|
Renal and urinary disorders
Urinary problems
|
5.3%
8/152 • Number of events 8 • AEs collected for each subject from the time of enrollment (signing informed consent form) through duration of follow-up visits (up to 60 months). The mean follow-up period for all subjects was 40.2 months (509 subject years).
An independent Adverse Event Adjudication Committee (three physicians: Colorectal, Gastroenterology, Urogynecology) reviewed all AEs and death data and assigned or verified correct assignment of codes, event seriousness, relatedness to the study device and/or procedure. All AEs listed here are device- and/or procedure-related only.
|
|
Reproductive system and breast disorders
Pelvic organ prolapse
|
5.9%
9/152 • Number of events 13 • AEs collected for each subject from the time of enrollment (signing informed consent form) through duration of follow-up visits (up to 60 months). The mean follow-up period for all subjects was 40.2 months (509 subject years).
An independent Adverse Event Adjudication Committee (three physicians: Colorectal, Gastroenterology, Urogynecology) reviewed all AEs and death data and assigned or verified correct assignment of codes, event seriousness, relatedness to the study device and/or procedure. All AEs listed here are device- and/or procedure-related only.
|
|
Injury, poisoning and procedural complications
Bleeding
|
0.66%
1/152 • Number of events 1 • AEs collected for each subject from the time of enrollment (signing informed consent form) through duration of follow-up visits (up to 60 months). The mean follow-up period for all subjects was 40.2 months (509 subject years).
An independent Adverse Event Adjudication Committee (three physicians: Colorectal, Gastroenterology, Urogynecology) reviewed all AEs and death data and assigned or verified correct assignment of codes, event seriousness, relatedness to the study device and/or procedure. All AEs listed here are device- and/or procedure-related only.
|
|
Gastrointestinal disorders
Defecatory problems
|
2.6%
4/152 • Number of events 4 • AEs collected for each subject from the time of enrollment (signing informed consent form) through duration of follow-up visits (up to 60 months). The mean follow-up period for all subjects was 40.2 months (509 subject years).
An independent Adverse Event Adjudication Committee (three physicians: Colorectal, Gastroenterology, Urogynecology) reviewed all AEs and death data and assigned or verified correct assignment of codes, event seriousness, relatedness to the study device and/or procedure. All AEs listed here are device- and/or procedure-related only.
|
|
Injury, poisoning and procedural complications
Other
|
9.2%
14/152 • Number of events 14 • AEs collected for each subject from the time of enrollment (signing informed consent form) through duration of follow-up visits (up to 60 months). The mean follow-up period for all subjects was 40.2 months (509 subject years).
An independent Adverse Event Adjudication Committee (three physicians: Colorectal, Gastroenterology, Urogynecology) reviewed all AEs and death data and assigned or verified correct assignment of codes, event seriousness, relatedness to the study device and/or procedure. All AEs listed here are device- and/or procedure-related only.
|
Additional Information
Dee Fenner, MD, Study Coordinating Investigator
University of Michigan, Professor of Obstetrics and Gynecology
Phone: 734-647-5866
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After the primary or the combined data article has been published, an Investigator may publish the study experience from his/her site. However, the Sponsor reserves the right to review the manuscript prior to submission in order to verify accuracy of the data. All publications will be reviewed by the sponsor in order to assure that no confidential information is disclosed. Such confidential information is not allowed for publishing.
- Publication restrictions are in place
Restriction type: OTHER