Trial Outcomes & Findings for Randomized Trial of Y Mesh vs Dual Mesh (NCT NCT02156687)
NCT ID: NCT02156687
Last Updated: 2020-11-24
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
59 participants
Primary outcome timeframe
one day intraoperative
Results posted on
2020-11-24
Participant Flow
Participant milestones
| Measure |
Coloplast, Inc. Restorelle Y Mesh
Subjects implanted with Coloplast, Inc. Restorelle Y mesh at the time of minimally invasive sacrocolpopexy.
|
Coloplast, Inc. Restorelle Dual Flat Mesh
Subjects implanted with Coloplast, Inc. Restorelle Dual flat mesh at the time of minimally invasive sacrocolpopexy.
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
29
|
|
Overall Study
COMPLETED
|
20
|
24
|
|
Overall Study
NOT COMPLETED
|
10
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Trial of Y Mesh vs Dual Mesh
Baseline characteristics by cohort
| Measure |
Cololast, Inc. Restorell Y Mesh
n=30 Participants
Y mesh
Y mesh: Y mesh
|
Coloplast, Inc. Restorelle Dual Flat Mesh
n=29 Participants
Dual flat mesh
Dual flat mesh: Dual flat mesh
|
Total
n=59 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
60.3 years
STANDARD_DEVIATION 7.3 • n=5 Participants
|
62.4 years
STANDARD_DEVIATION 8.1 • n=7 Participants
|
61 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
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
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
28 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
55 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
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Body Mass Index (BMI)
|
28.9 kg/m^2
STANDARD_DEVIATION 3.5 • n=5 Participants
|
28.2 kg/m^2
STANDARD_DEVIATION 4.2 • n=7 Participants
|
28.5 kg/m^2
STANDARD_DEVIATION 3.9 • n=5 Participants
|
|
Tobacco use
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Parity
|
3 pregnancies
n=5 Participants
|
2 pregnancies
n=7 Participants
|
3 pregnancies
n=5 Participants
|
|
Prior prolapse surgery
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Prolapse Stage 1
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Prolapse Stage 2
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Prolapse Stage 3
|
20 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
|
Prolapse Stage 4
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: one day intraoperativeOutcome measures
| Measure |
Coloplast, Inc. Restorelle Y Mesh
n=30 Participants
Y mesh
Y mesh: Y mesh
|
Coloplast, Inc. Restorelle Dual Flat Mesh
n=29 Participants
Dual flat mesh
Dual flat mesh: Dual flat mesh
|
|---|---|---|
|
Total Suturing Time for Mesh Placement = Time From Insertion of Y Mesh or First Flat Mesh Arm Into Pelvis to Last Sacral Suture Placed
|
46 minutes
Standard Deviation 14.7
|
46.3 minutes
Standard Deviation 12.3
|
PRIMARY outcome
Timeframe: one day intraoperativeOutcome measures
| Measure |
Coloplast, Inc. Restorelle Y Mesh
n=30 Participants
Y mesh
Y mesh: Y mesh
|
Coloplast, Inc. Restorelle Dual Flat Mesh
n=29 Participants
Dual flat mesh
Dual flat mesh: Dual flat mesh
|
|---|---|---|
|
Total OR Time = Operating Room Time of Entry and Exit
|
204.2 minutes
Standard Deviation 52.8
|
204.5 minutes
Standard Deviation 43.7
|
SECONDARY outcome
Timeframe: 24 monthsMean difference between baseline (pre-procedure) and 24-months post-procedure. The POPDI is a six-item measure from the PFDI-20 which measures 6 different pelvic organ prolapse symptoms and degree of bother. The scale exists from 0-100 (0=no symptoms, 100=worse symptoms).
Outcome measures
| Measure |
Coloplast, Inc. Restorelle Y Mesh
n=20 Participants
Y mesh
Y mesh: Y mesh
|
Coloplast, Inc. Restorelle Dual Flat Mesh
n=24 Participants
Dual flat mesh
Dual flat mesh: Dual flat mesh
|
|---|---|---|
|
Post-operative Mean Difference POPDI at 24 Months
|
-32.5 score on a scale
Standard Deviation 24.1
|
-40.7 score on a scale
Standard Deviation 26.9
|
SECONDARY outcome
Timeframe: 24 monthsMean difference between baseline (pre-procedure) and 24-months post-procedure. The CRADI is a eight-item measure from the PFDI-20 which measures 8 different pelvic organ prolapse symptoms and degree of bother. The scale exists from 0-100 (0=no symptoms, 100=worse symptoms).
Outcome measures
| Measure |
Coloplast, Inc. Restorelle Y Mesh
n=20 Participants
Y mesh
Y mesh: Y mesh
|
Coloplast, Inc. Restorelle Dual Flat Mesh
n=24 Participants
Dual flat mesh
Dual flat mesh: Dual flat mesh
|
|---|---|---|
|
Postoperative Mean Difference CRADI at 24 Months
|
-24.2 score on a scale
Standard Deviation 20.6
|
-20.2 score on a scale
Standard Deviation 16.1
|
SECONDARY outcome
Timeframe: 24 monthsMean difference between baseline (pre-procedure) and 24-months post-procedure. The UDI is a six-item measure from the PFDI-20 which measures 6 different pelvic organ prolapse symptoms and degree of bother. The scale exists from 0-100 (0=no symptoms, 100=worse symptoms).
Outcome measures
| Measure |
Coloplast, Inc. Restorelle Y Mesh
n=20 Participants
Y mesh
Y mesh: Y mesh
|
Coloplast, Inc. Restorelle Dual Flat Mesh
n=24 Participants
Dual flat mesh
Dual flat mesh: Dual flat mesh
|
|---|---|---|
|
Postoperative Mean Difference UDI at 24 Months
|
-39.0 score on a scale
Standard Deviation 27.0
|
-33.2 score on a scale
Standard Deviation 18.9
|
SECONDARY outcome
Timeframe: 24 monthsSubjective Recurrence was defined as patients who complained of vaginal bulge symptoms (Question #3 on the PFDI-20).
Outcome measures
| Measure |
Coloplast, Inc. Restorelle Y Mesh
n=20 Participants
Y mesh
Y mesh: Y mesh
|
Coloplast, Inc. Restorelle Dual Flat Mesh
n=24 Participants
Dual flat mesh
Dual flat mesh: Dual flat mesh
|
|---|---|---|
|
Postoperative Subjective Recurrence at 24 Months
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 24 monthsObjective Recurrence
Outcome measures
| Measure |
Coloplast, Inc. Restorelle Y Mesh
n=20 Participants
Y mesh
Y mesh: Y mesh
|
Coloplast, Inc. Restorelle Dual Flat Mesh
n=24 Participants
Dual flat mesh
Dual flat mesh: Dual flat mesh
|
|---|---|---|
|
Postoperative Objective Recurrence at 24 Months
|
5 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 24 monthsMesh Erosion was defined as presence of eroded mesh in the vagina on examination postoperatively up to 24-months after surgery.
Outcome measures
| Measure |
Coloplast, Inc. Restorelle Y Mesh
n=20 Participants
Y mesh
Y mesh: Y mesh
|
Coloplast, Inc. Restorelle Dual Flat Mesh
n=24 Participants
Dual flat mesh
Dual flat mesh: Dual flat mesh
|
|---|---|---|
|
Reported Mesh Erosion at 24 Months
|
0 Participants
|
0 Participants
|
Adverse Events
Coloplast, Inc. Restorelle Y Mesh
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Coloplast, Inc. Restorelle Dual Flat Mesh
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place