Trial Outcomes & Findings for Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms (NCT NCT00565136)
NCT ID: NCT00565136
Last Updated: 2016-05-23
Results Overview
Includes solid and liquid stools, as measured by the mean rate obtained using a subject-reported bowel diary. The 3 month post-treatment visit was the primary endpoint time period.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
29 participants
Primary outcome timeframe
Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatment
Results posted on
2016-05-23
Participant Flow
Subjects enrolled at 5 U.S. study centers (medical clinics) from September 2007 to August 2008. The maximum allowed enrollment number from one site is 12.
After signing informed consent and prior to implant, subjects completed a 3-week bowel diary to describe the FI episodes, Fecal Incontinence Quality of Life scale, Wexner Score, Symptom Severity Scale in Fecal Incontinence, pain intensity scale, and dynamic MRI or defecography.
Participant milestones
| Measure |
TOPAS
TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support
|
|---|---|
|
Overall Study
STARTED
|
29
|
|
Overall Study
COMPLETED
|
26
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
TOPAS
TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support
|
|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Protocol Violation
|
1
|
Baseline Characteristics
Evaluation of Outcomes of Restoring Pelvic Floor Support With TOPAS in Women With Moderate Fecal Incontinence Symptoms
Baseline characteristics by cohort
| Measure |
TOPAS
n=29 Participants
TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support
|
|---|---|
|
Age, Continuous
|
60.6 years
STANDARD_DEVIATION 13.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White / Caucasian
|
28 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 participants
n=5 Participants
|
|
Height
|
164.8 cm
STANDARD_DEVIATION 5.9 • n=5 Participants
|
|
Weight
|
76.3 kg
STANDARD_DEVIATION 19.6 • n=5 Participants
|
|
Body Mass Index
|
28.1 kg/[m]^2
STANDARD_DEVIATION 7.1 • n=5 Participants
|
|
Gravidity
|
3.6 pregnancies
STANDARD_DEVIATION 2.1 • n=5 Participants
|
|
Parity
|
2.9 births
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Number Cesarean Births
|
0.1 deliveries
STANDARD_DEVIATION 0.3 • n=5 Participants
|
|
Number of Vaginal Births
|
2.8 deliveries
STANDARD_DEVIATION 1.1 • n=5 Participants
|
|
Menopausal Status
Pre-menopausal
|
7 participants
n=5 Participants
|
|
Menopausal Status
Post-menopausal
|
22 participants
n=5 Participants
|
|
Fecal Incontinence Treatment History (failed modalities)
Diet modification
|
25 participants
n=5 Participants
|
|
Fecal Incontinence Treatment History (failed modalities)
FI medication
|
9 participants
n=5 Participants
|
|
Fecal Incontinence Treatment History (failed modalities)
Biofeedback
|
11 participants
n=5 Participants
|
|
Fecal Incontinence Treatment History (failed modalities)
Pelvic surgery
|
3 participants
n=5 Participants
|
|
Fecal Incontinence Treatment History (failed modalities)
Other
|
6 participants
n=5 Participants
|
|
Etiology of Fecal Incontinence
Neurological
|
2 participants
n=5 Participants
|
|
Etiology of Fecal Incontinence
Anorectal trauma
|
4 participants
n=5 Participants
|
|
Etiology of Fecal Incontinence
Obstetric trauma
|
10 participants
n=5 Participants
|
|
Etiology of Fecal Incontinence
Idiopathic/Unknown
|
15 participants
n=5 Participants
|
|
Etiology of Fecal Incontinence
Congenital abnormality
|
0 participants
n=5 Participants
|
|
Etiology of Fecal Incontinence
Other
|
0 participants
n=5 Participants
|
|
Colonoscopy within past 10 years
Yes
|
24 participants
n=5 Participants
|
|
Colonoscopy within past 10 years
No
|
5 participants
n=5 Participants
|
|
Colonoscopy Results
Normal
|
15 participants
n=5 Participants
|
|
Colonoscopy Results
Abnormal
|
8 participants
n=5 Participants
|
|
Colonoscopy Results
Unknown
|
6 participants
n=5 Participants
|
|
Colonoscopy Results
Other
|
0 participants
n=5 Participants
|
|
Digital Rectal Exam - Soft Tissue Scarring
Yes
|
5 participants
n=5 Participants
|
|
Digital Rectal Exam - Soft Tissue Scarring
No
|
24 participants
n=5 Participants
|
|
Digital Rectal Exam - Hemorrhoids
Yes
|
2 participants
n=5 Participants
|
|
Digital Rectal Exam - Hemorrhoids
No
|
27 participants
n=5 Participants
|
|
Digital Rectal Exam - Anal Resting Tone
Yes
|
27 participants
n=5 Participants
|
|
Digital Rectal Exam - Anal Resting Tone
No
|
2 participants
n=5 Participants
|
|
Endoanal Ultrasound or Magnetic Resonance Imaging Completed
Endoanal Ultrasound
|
23 participants
n=5 Participants
|
|
Endoanal Ultrasound or Magnetic Resonance Imaging Completed
MRI
|
6 participants
n=5 Participants
|
|
Endoanal Ultrasound/Magnetic Resonance Imaging - Sphincter Defect
Yes
|
10 participants
n=5 Participants
|
|
Endoanal Ultrasound/Magnetic Resonance Imaging - Sphincter Defect
No
|
19 participants
n=5 Participants
|
|
Endoanal Ultrasound/Magnetic Resonance Imaging - Extent of Sphincter Defect
|
95.0 degrees
STANDARD_DEVIATION 50.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatmentPopulation: The FI Bowel Diary was completed by the number of subjects at each visit as follows: Baseline: N=29, 6 Week: N=26, 3 Month: N=27, 6 Month: N=24, 12 Month: N=23, 24 Month: N=26
Includes solid and liquid stools, as measured by the mean rate obtained using a subject-reported bowel diary. The 3 month post-treatment visit was the primary endpoint time period.
Outcome measures
| Measure |
TOPAS
n=29 Participants
TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support
|
|---|---|
|
Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment
Baseline (n = 29)
|
6.9 Number of FI episodes/14 day period
Standard Deviation 5.1
|
|
Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment
6 Week (n = 26)
|
3.0 Number of FI episodes/14 day period
Standard Deviation 3.2
|
|
Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment
3 Month (primary endpoint time period, n = 27)
|
3.7 Number of FI episodes/14 day period
Standard Deviation 4.4
|
|
Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment
6 Month (n = 24)
|
3.7 Number of FI episodes/14 day period
Standard Deviation 5.0
|
|
Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment
12 Month (n = 23)
|
3.1 Number of FI episodes/14 day period
Standard Deviation 4.1
|
|
Fecal Incontinence Incidence From Baseline (Pre-treatment) Through 24 Months Post-treatment
24 Month (n = 26)
|
3.5 Number of FI episodes/14 day period
Standard Deviation 3.4
|
SECONDARY outcome
Timeframe: Through 24 month post-treatmentPopulation: Includes all subjects implanted with the TOPAS device
Complications are defined as all adverse events reported during the 24 month follow-up period including serious/non-serious events and events related/not related to the device and/or procedure. Incidence rate is calculated as: (total number of adverse events reported in the 24 month follow-up period) / (total number of subjects implanted = 29)
Outcome measures
| Measure |
TOPAS
n=29 Participants
TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support
|
|---|---|
|
Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period
All Adverse Events
|
2.34 events per 24 months/participant
|
|
Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period
Device and/or Procedure-Related Adverse Events
|
0.66 events per 24 months/participant
|
|
Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period
All Serious Adverse Events
|
0.17 events per 24 months/participant
|
|
Incidence Rate of Complications During the 24 Month Post-Treatment Follow-up Period
Device and/or Procedure Related Serious Events
|
0.03 events per 24 months/participant
|
SECONDARY outcome
Timeframe: Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatmentPopulation: The Wexner Score was completed by the number of subjects at each visit as follows: Baseline: N=29, 6 Week: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23
The Wexner Score (also known as the Cleveland Clinic Florida Incontinence Score) is a subject-completed questionnaire that asks about the frequency of incontinence to gas, liquid, solid, of the need to wear pads, and of lifestyle changes (scored on a frequency scale from 0 (=absent) to 4 (daily). An overall Wexner Score is computed from these five components and a score of 0 means perfect control and 20 means complete incontinence.
Outcome measures
| Measure |
TOPAS
n=29 Participants
TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support
|
|---|---|
|
Fecal Incontinence Symptoms as Measured by the Wexner Score
Baseline (n = 29)
|
13.2 units on a scale
Standard Deviation 2.6
|
|
Fecal Incontinence Symptoms as Measured by the Wexner Score
6 Week (n = 29)
|
7.6 units on a scale
Standard Deviation 4.0
|
|
Fecal Incontinence Symptoms as Measured by the Wexner Score
3 Month (n = 26)
|
7.5 units on a scale
Standard Deviation 4.1
|
|
Fecal Incontinence Symptoms as Measured by the Wexner Score
6 Month (n = 25)
|
8.5 units on a scale
Standard Deviation 4.4
|
|
Fecal Incontinence Symptoms as Measured by the Wexner Score
12 Month (n = 25)
|
8.7 units on a scale
Standard Deviation 4.0
|
|
Fecal Incontinence Symptoms as Measured by the Wexner Score
24 Month (n = 23)
|
9.9 units on a scale
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Baseline (pre-treatment), 6 Week, 3 Month, 6 Month, 12 Month and 24 Month post-treatmentPopulation: The Symptom Severity Scale in Fecal Incontinence was completed by the number of subjects at each visit as follows: Baseline: N=29, 6 Week: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23
The Symptom Severity Scale in Fecal Incontinence is a subject-completed questionnaire that asks about the symptoms of fecal incontinence in the following areas: frequency, stool composition, stool amount, and degree of urgency. The total score is measured on a 0 (best) to 13 (worst) scale. Scores of 1-6, 7-10, and 11-13 were categorized as mild, moderate, and severe fecal incontinence, respectively.
Outcome measures
| Measure |
TOPAS
n=29 Participants
TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support
|
|---|---|
|
Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence
Baseline (n = 29)
|
10.1 units on a scale
Standard Deviation 1.4
|
|
Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence
6 Week (n = 29)
|
7.4 units on a scale
Standard Deviation 2.4
|
|
Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence
3 Month (n = 26)
|
7.2 units on a scale
Standard Deviation 2.7
|
|
Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence
6 Month (n = 25)
|
7.5 units on a scale
Standard Deviation 2.8
|
|
Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence
12 Month (n = 25)
|
8.0 units on a scale
Standard Deviation 2.7
|
|
Fecal Incontinence Symptoms as Measured by Symptom Severity Scale in Fecal Incontinence
24 Month (n = 23)
|
8.1 units on a scale
Standard Deviation 2.4
|
SECONDARY outcome
Timeframe: Baseline (pre-treatment), 3 Month, 6 Month, 12 Month and 24 Month post-treatmentPopulation: The Fecal Incontinence Quality of Life Assessment was completed by the number of subjects at each visit as follows: Baseline: N=29, 3 Month: N=26, 6 Month: N=25, 12 Month: N=25, 24 Month: N=23
The Fecal Incontinence Quality of Life Assessment is a subject-completed questionnaire. It is measured in each of four areas of depression (7 items), lifestyle (10 items), coping (9 items), and embarrassment (3 items). Area scores are measured on a 1 (worse) to 4 (best) scale and are each the average of their component individual item scores measured on the same scale.
Outcome measures
| Measure |
TOPAS
n=29 Participants
TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support
|
|---|---|
|
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
Depression - Baseline (n = 29)
|
2.7 units on a scale
Standard Deviation 0.8
|
|
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
Depression - 3 Month (n = 26)
|
3.3 units on a scale
Standard Deviation 0.7
|
|
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
Depression - 6 Month (n = 25)
|
3.2 units on a scale
Standard Deviation 0.8
|
|
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
Depression - 12 Month (n = 25)
|
3.3 units on a scale
Standard Deviation 0.8
|
|
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
Depression - 24 Month (n = 23)
|
3.3 units on a scale
Standard Deviation 0.7
|
|
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
Lifestyle - Baseline (n = 29)
|
2.7 units on a scale
Standard Deviation 0.8
|
|
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
Lifestyle - 3 Month (n = 26)
|
3.4 units on a scale
Standard Deviation 0.7
|
|
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
Lifestyle - 6 Month (n = 25)
|
3.4 units on a scale
Standard Deviation 0.7
|
|
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
Lifestyle - 12 Month (n = 25)
|
3.3 units on a scale
Standard Deviation 0.8
|
|
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
Lifestyle - 24 Month (n = 23)
|
3.5 units on a scale
Standard Deviation 0.7
|
|
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
Coping - Baseline (n = 29)
|
1.9 units on a scale
Standard Deviation 0.5
|
|
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
Coping - 3 Month (n = 26)
|
2.9 units on a scale
Standard Deviation 0.8
|
|
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
Coping - 6 Month (n = 25)
|
2.8 units on a scale
Standard Deviation 0.8
|
|
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
Coping - 12 Month (n = 25)
|
2.8 units on a scale
Standard Deviation 0.9
|
|
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
Coping - 24 Month (n = 23)
|
2.8 units on a scale
Standard Deviation 0.9
|
|
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
Embarrassment - Baseline (n = 29)
|
1.8 units on a scale
Standard Deviation 0.6
|
|
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
Embarrassment - 3 Month (n = 26)
|
2.9 units on a scale
Standard Deviation 0.9
|
|
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
Embarrassment - 6 Month (n = 25)
|
2.9 units on a scale
Standard Deviation 1.0
|
|
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
Embarrassment - 12 Month (n = 25)
|
3.0 units on a scale
Standard Deviation 0.9
|
|
Quality of Life Assessment as Measured by Fecal Incontinence Quality of Life
Embarrassment - 24 Month (n = 23)
|
2.9 units on a scale
Standard Deviation 1.0
|
SECONDARY outcome
Timeframe: Baseline (pre-treatment), 6 Week post-treatmentPopulation: The Pain Intensity Scale was completed by the number of subjects at each visit as follows: Baseline: N=29, 6 Week: N=29
The Pain Intensity Scale is a subject completed questionnaire. Scores are measured on 0 (no pain) to 10 (worst possible pain) scale.
Outcome measures
| Measure |
TOPAS
n=29 Participants
TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support
|
|---|---|
|
Pain Intensity as Measured by the Pain Intensity Scale
Baseline (n = 29)
|
1.0 units on a scale
Standard Deviation 1.5
|
|
Pain Intensity as Measured by the Pain Intensity Scale
6 Week (n = 29)
|
0.4 units on a scale
Standard Deviation 0.8
|
SECONDARY outcome
Timeframe: Duration of the device implant procedurePopulation: All enrolled/implanted subjects were included in this analysis
Outcome measures
| Measure |
TOPAS
n=29 Participants
TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support
|
|---|---|
|
Intra- and Peri-Surgical Parameters: Length of Procedure
|
23 minutes
Standard Deviation 8
|
SECONDARY outcome
Timeframe: Length of the hospital stay for the device implant procedurePopulation: All enrolled/implanted subjects were included in this analysis
Outcome measures
| Measure |
TOPAS
n=29 Participants
TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support
|
|---|---|
|
Intra- and Peri-Surgical Parameters: Length of Hospital Stay
|
22.6 hours
Standard Deviation 11.6
|
SECONDARY outcome
Timeframe: Duration of the device implant procedure (an average of 23 minutes)Population: All enrolled/implanted subjects were included in this analysis
Outcome measures
| Measure |
TOPAS
n=29 Participants
TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support
|
|---|---|
|
Intra- and Peri-Surgical Parameters: Estimated Blood Loss During Implant Procedure
|
15 ml
Standard Deviation 13
|
POST_HOC outcome
Timeframe: 6 Weeks, 3 Month, 6 Month, 12 Month and 24 Month post-treatmentPopulation: Two subjects were enrolled who recorded no FI episodes at baseline and were excluded from this analysis. Missing data was not imputed and was considered a treatment failure. The Bowel Diary was completed by the number of subjects at each visit as follows: 6 Week: N=24, 3 Month: N=25, 6 Month: N=22, 12 Month: N=21, 24 Month: N=24
Includes solid and liquid stools, as measured by a subject-reported bowel diary
Outcome measures
| Measure |
TOPAS
n=27 Participants
TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support
|
|---|---|
|
Percentage of Subjects With Greater Than or Equal to a 50 Percent Reduction in FI Episodes From Baseline
6 Week (n = 24)
|
59.3 percentage participants
Interval 41.7 to 75.2
|
|
Percentage of Subjects With Greater Than or Equal to a 50 Percent Reduction in FI Episodes From Baseline
3 Month (n = 25)
|
63.0 percentage participants
Interval 45.3 to 78.3
|
|
Percentage of Subjects With Greater Than or Equal to a 50 Percent Reduction in FI Episodes From Baseline
6 Month (n = 22)
|
51.9 percentage participants
Interval 34.7 to 68.7
|
|
Percentage of Subjects With Greater Than or Equal to a 50 Percent Reduction in FI Episodes From Baseline
12 Month (n = 21)
|
40.7 percentage participants
Interval 24.8 to 58.3
|
|
Percentage of Subjects With Greater Than or Equal to a 50 Percent Reduction in FI Episodes From Baseline
24 Month (n = 24)
|
55.6 percentage participants
Interval 38.2 to 72.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (pre-treatment), 6 Month post-treatmentOutcome measures
| Measure |
TOPAS
n=29 Participants
TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support
|
|---|---|
|
Anal Manometry: Maximum Resting Pressure
Baseline (n = 28)
|
29.2 mmHg
Standard Deviation 23.2
|
|
Anal Manometry: Maximum Resting Pressure
6 Month (n = 20)
|
37.7 mmHg
Standard Deviation 25.8
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (pre-treatment), 6 Month post-treatmentOutcome measures
| Measure |
TOPAS
n=29 Participants
TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support
|
|---|---|
|
Anal Manometry: Maximum Squeeze Pressure
Baseline (n = 28)
|
53.2 mmHg
Standard Deviation 38.7
|
|
Anal Manometry: Maximum Squeeze Pressure
6 Month (n = 20)
|
51.8 mmHg
Standard Deviation 32.9
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (pre-treatment), 6 Month post-treatmentOutcome measures
| Measure |
TOPAS
n=29 Participants
TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support
|
|---|---|
|
Anal Manometry: Rectal First Sensation
Baseline (n = 29)
|
37.6 cc
Standard Deviation 22.3
|
|
Anal Manometry: Rectal First Sensation
6 Month (n = 23)
|
41.7 cc
Standard Deviation 30.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (pre-treatment), 6 Month post-treatmentOutcome measures
| Measure |
TOPAS
n=29 Participants
TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support
|
|---|---|
|
Anal Manometry: Maximum Tolerable Volume
Baseline (n = 26)
|
115.3 cc
Standard Deviation 52.4
|
|
Anal Manometry: Maximum Tolerable Volume
6 Month (n = 20)
|
126.3 cc
Standard Deviation 49.6
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline (pre-treatment), 6 Month post-treatmentPudendal Nerve Terminal Motor Latency is a measure of the time it takes for stimulation of the pudendal nerve to elicit contraction of the pelvic floor muscles and anal sphincter. It is a surrogate marker of pudendal nerve injuries and a means of ascertaining whether anal sphincter weakness is attributable to pudendal nerve injury, sphincter defect, or both.
Outcome measures
| Measure |
TOPAS
n=29 Participants
TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support
|
|---|---|
|
Pudendal Nerve Terminal Motor Latency
Baseline - Right Pudendal Nerve Latency (n = 16)
|
3.3 msec
Standard Deviation 2.6
|
|
Pudendal Nerve Terminal Motor Latency
6 Month - Right Pudendal Nerve Latency (n = 10)
|
3.8 msec
Standard Deviation 2.8
|
|
Pudendal Nerve Terminal Motor Latency
Baseline - Left Pudendal Nerve Latency (n = 17)
|
2.9 msec
Standard Deviation 2.4
|
|
Pudendal Nerve Terminal Motor Latency
6 Month - Left Pudendal Nerve Latency (n = 12)
|
3.1 msec
Standard Deviation 2.3
|
Adverse Events
TOPAS
Serious events: 5 serious events
Other events: 22 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TOPAS
n=29 participants at risk
TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support
|
|---|---|
|
Nervous system disorders
Low Back Pain/Disk Herniation
|
3.4%
1/29 • Number of events 1 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Respiratory, thoracic and mediastinal disorders
Blood Clot in Lungs
|
3.4%
1/29 • Number of events 1 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Infections and infestations
Right Leg Cellulitis
|
3.4%
1/29 • Number of events 1 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Musculoskeletal and connective tissue disorders
Costochondoritis
|
3.4%
1/29 • Number of events 1 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Musculoskeletal and connective tissue disorders
Carpel Tunnel
|
3.4%
1/29 • Number of events 1 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
Other adverse events
| Measure |
TOPAS
n=29 participants at risk
TOPAS AMS Pelvic Floor Repair System
TOPAS : A mesh sling permanently implanted to increase pelvic floor support
|
|---|---|
|
Renal and urinary disorders
Urinary Incontinence (De Novo)
|
17.2%
5/29 • Number of events 5 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Renal and urinary disorders
Urinary Tract Infection
|
13.8%
4/29 • Number of events 4 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Reproductive system and breast disorders
Dyspareunia (De Novo)
|
10.3%
3/29 • Number of events 3 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Gastrointestinal disorders
Worsening Fecal Incontinence
|
10.3%
3/29 • Number of events 3 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Infections and infestations
Infection (other than urinary tract infection)
|
10.3%
3/29 • Number of events 3 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Reproductive system and breast disorders
Abnormal Uterine Bleeding (De Novo)
|
3.4%
1/29 • Number of events 2 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Reproductive system and breast disorders
Worsening Vaginal Prolapse
|
6.9%
2/29 • Number of events 2 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Renal and urinary disorders
Worsening Urinary Incontinence
|
6.9%
2/29 • Number of events 2 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Musculoskeletal and connective tissue disorders
Leg Pain
|
6.9%
2/29 • Number of events 2 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Gastrointestinal disorders
Constipation
|
3.4%
1/29 • Number of events 2 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Psychiatric disorders
Worsening Depression
|
6.9%
2/29 • Number of events 2 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Reproductive system and breast disorders
Erosion (non-TOPAS Mesh Device)
|
3.4%
1/29 • Number of events 1 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Reproductive system and breast disorders
Vaginal Prolapse (De Novo)
|
3.4%
1/29 • Number of events 1 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Reproductive system and breast disorders
Persistent Vaginal Discharge
|
3.4%
1/29 • Number of events 1 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Musculoskeletal and connective tissue disorders
Buttock Pain
|
3.4%
1/29 • Number of events 1 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Reproductive system and breast disorders
Pelvic Pain
|
3.4%
1/29 • Number of events 1 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Reproductive system and breast disorders
Excessive Internal Fibrosis
|
3.4%
1/29 • Number of events 1 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Renal and urinary disorders
Urinary Retention
|
3.4%
1/29 • Number of events 1 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Gastrointestinal disorders
Diarrhea
|
3.4%
1/29 • Number of events 1 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
3.4%
1/29 • Number of events 1 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Respiratory, thoracic and mediastinal disorders
Influenza
|
3.4%
1/29 • Number of events 1 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
|
Investigations
Other (unclassified)
|
44.8%
13/29 • Number of events 28 • From implant to 24 months post-treatment
The relationship of all AEs to the procedure and/or device was assessed by the investigator. Events were classified as "definitely not", "remotely", "possibly", "probably" or "definitely" related to the procedure/device. All AEs underwent blinded adjudication for coding and serious determination by the Coordinating Investigator
|
Additional Information
Peter Rosenblatt, MD; Director of Urogynecology
Boston Urogynecology Associates
Phone: (617) 354-5452
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60