Trial Outcomes & Findings for Permanent Versus Absorbable Colpopexy Trial (NCT NCT02277925)
NCT ID: NCT02277925
Last Updated: 2019-11-19
Results Overview
Total number of participants with vaginal mesh and/or suture exposure thru 1 year
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
204 participants
Primary outcome timeframe
1 year
Results posted on
2019-11-19
Participant Flow
Participant milestones
| Measure |
Gore-Tex Permanent Suture
Participants in this arm will receive Gore-Tex permanent suture
|
PDS Delayed Absorbable Suture
Participants in this arm will receive 2-0 PDS delayed absorbable suture
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
102
|
|
Overall Study
Surgery
|
99
|
101
|
|
Overall Study
COMPLETED
|
95
|
87
|
|
Overall Study
NOT COMPLETED
|
7
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Permanent Versus Absorbable Colpopexy Trial
Baseline characteristics by cohort
| Measure |
Gore-Tex Permanent Suture
n=99 Participants
Participants in this arm will receive Gore-Tex permanent suture
|
PDS Delayed Absorbable Suture
n=101 Participants
Participants in this arm will receive 2-0 PDS delayed absorbable suture
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.7 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
59.0 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
59.3 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
99 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
200 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
|
14 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
85 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
175 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
7 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
90 Participants
n=5 Participants
|
89 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
99 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
200 Participants
n=5 Participants
|
|
Current smoker
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Body mass index (kg/m^2)
|
27.5 kg/m^2
STANDARD_DEVIATION 5.0 • n=5 Participants
|
57.5 kg/m^2
STANDARD_DEVIATION 4.7 • n=7 Participants
|
27.5 kg/m^2
STANDARD_DEVIATION 4.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Participants who underwent sacral colpopexy surgery with 1-year follow up data
Total number of participants with vaginal mesh and/or suture exposure thru 1 year
Outcome measures
| Measure |
Gore-Tex Permanent Suture
n=95 Participants
Participants in this arm will receive Gore-Tex permanent suture
|
PDS Delayed Absorbable Suture
n=87 Participants
Participants in this arm will receive 2-0 PDS delayed absorbable suture
|
|---|---|---|
|
Number of Participants With Vaginal Mesh or Suture Exposure
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Participants who underwent sacral colpopexy surgery with 1-year follow-up
Total number of participants with treatment success, which was a composite measure of 1) leading edge of prolapse not beyond hymen and apex not descended \> 1/3 of vaginal length, 2) no subjective feeling of bulge on validated questionnaire, and 3) no prolapse re-treatment with pessary or surgery
Outcome measures
| Measure |
Gore-Tex Permanent Suture
n=95 Participants
Participants in this arm will receive Gore-Tex permanent suture
|
PDS Delayed Absorbable Suture
n=87 Participants
Participants in this arm will receive 2-0 PDS delayed absorbable suture
|
|---|---|---|
|
Number of Participants With Treatment Success
|
88 Participants
|
83 Participants
|
SECONDARY outcome
Timeframe: 1 yearCondition-specific questionnaire, pelvic floor distress inventory-20 (PFDI-20) is used. Minimum value is 0. Maximum is 300. Higher scores mean more bothersome symptoms.
Outcome measures
| Measure |
Gore-Tex Permanent Suture
n=95 Participants
Participants in this arm will receive Gore-Tex permanent suture
|
PDS Delayed Absorbable Suture
n=87 Participants
Participants in this arm will receive 2-0 PDS delayed absorbable suture
|
|---|---|---|
|
Pelvic Floor Distress Inventory-20 (PFDI-20) Mean Score
|
42.4 score on a scale
Standard Deviation 35.9
|
37.9 score on a scale
Standard Deviation 33.9
|
Adverse Events
Gore-Tex Permanent Suture
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
PDS Delayed Absorbable Suture
Serious events: 5 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Gore-Tex Permanent Suture
n=99 participants at risk
Participants in this arm will receive Gore-Tex permanent suture
|
PDS Delayed Absorbable Suture
n=101 participants at risk
Participants in this arm will receive 2-0 PDS delayed absorbable suture
|
|---|---|---|
|
Surgical and medical procedures
Ureteral injury
|
0.00%
0/99 • Adverse events were collected from surgery to 1 year follow-up visit, approximate total of 14 months
Systematic assessment was performed with medical records review and detailed adverse event case report forms that were completed at study visits.
|
0.99%
1/101 • Number of events 1 • Adverse events were collected from surgery to 1 year follow-up visit, approximate total of 14 months
Systematic assessment was performed with medical records review and detailed adverse event case report forms that were completed at study visits.
|
|
Infections and infestations
Sepsis
|
0.00%
0/99 • Adverse events were collected from surgery to 1 year follow-up visit, approximate total of 14 months
Systematic assessment was performed with medical records review and detailed adverse event case report forms that were completed at study visits.
|
0.99%
1/101 • Number of events 1 • Adverse events were collected from surgery to 1 year follow-up visit, approximate total of 14 months
Systematic assessment was performed with medical records review and detailed adverse event case report forms that were completed at study visits.
|
|
Blood and lymphatic system disorders
Pulmonary embolism
|
0.00%
0/99 • Adverse events were collected from surgery to 1 year follow-up visit, approximate total of 14 months
Systematic assessment was performed with medical records review and detailed adverse event case report forms that were completed at study visits.
|
0.99%
1/101 • Number of events 1 • Adverse events were collected from surgery to 1 year follow-up visit, approximate total of 14 months
Systematic assessment was performed with medical records review and detailed adverse event case report forms that were completed at study visits.
|
|
Surgical and medical procedures
Port site hernia
|
0.00%
0/99 • Adverse events were collected from surgery to 1 year follow-up visit, approximate total of 14 months
Systematic assessment was performed with medical records review and detailed adverse event case report forms that were completed at study visits.
|
0.99%
1/101 • Number of events 1 • Adverse events were collected from surgery to 1 year follow-up visit, approximate total of 14 months
Systematic assessment was performed with medical records review and detailed adverse event case report forms that were completed at study visits.
|
|
Gastrointestinal disorders
Bowel obstruction
|
1.0%
1/99 • Number of events 1 • Adverse events were collected from surgery to 1 year follow-up visit, approximate total of 14 months
Systematic assessment was performed with medical records review and detailed adverse event case report forms that were completed at study visits.
|
0.00%
0/101 • Adverse events were collected from surgery to 1 year follow-up visit, approximate total of 14 months
Systematic assessment was performed with medical records review and detailed adverse event case report forms that were completed at study visits.
|
|
Infections and infestations
Infected hematoma
|
0.00%
0/99 • Adverse events were collected from surgery to 1 year follow-up visit, approximate total of 14 months
Systematic assessment was performed with medical records review and detailed adverse event case report forms that were completed at study visits.
|
0.99%
1/101 • Number of events 1 • Adverse events were collected from surgery to 1 year follow-up visit, approximate total of 14 months
Systematic assessment was performed with medical records review and detailed adverse event case report forms that were completed at study visits.
|
Other adverse events
| Measure |
Gore-Tex Permanent Suture
n=99 participants at risk
Participants in this arm will receive Gore-Tex permanent suture
|
PDS Delayed Absorbable Suture
n=101 participants at risk
Participants in this arm will receive 2-0 PDS delayed absorbable suture
|
|---|---|---|
|
Surgical and medical procedures
Intraoperative complications
|
10.1%
10/99 • Number of events 10 • Adverse events were collected from surgery to 1 year follow-up visit, approximate total of 14 months
Systematic assessment was performed with medical records review and detailed adverse event case report forms that were completed at study visits.
|
5.0%
5/101 • Number of events 5 • Adverse events were collected from surgery to 1 year follow-up visit, approximate total of 14 months
Systematic assessment was performed with medical records review and detailed adverse event case report forms that were completed at study visits.
|
Additional Information
Jennifer Wu, MD, MPH
University of North Carolina at Chapel Hill
Phone: 919-966-0014
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place