Trial Outcomes & Findings for Efficacy Study of Vaginal Mesh for Prolapse (NCT NCT00475540)
NCT ID: NCT00475540
Last Updated: 2022-10-12
Results Overview
3 different measures for Anatomic cure using POPQ measurements: 1. POP-Q at Stage I or less\* (POP-Q points Ba, Bp or C -1 or less); 2. no prolapse beyond the hymen (Ba, Bp or C 0 or less); 3. no prolapse beyond the hymen (Ba, Bp 0 or less) with adequate apical support above the midvagina (C to TVL/2 or less) No bulge symptoms using Pelvic Floor Distress Inventory, PFDI question 3; do you see or feel a bulge in the vaginal area with response of no. Patient Satisfaction using Patient Global Impression of Improvement with response of very much better or much better
COMPLETED
NA
65 participants
3 year
2022-10-12
Participant Flow
From January 3, 2007 to August 1, 2009, 238 women were identified as eligible and 65 randomized (32 to experimental group (mesh) and 33 to control group (non-mesh)). All patients completed 3 month followup. Study recruitment halted at median followup of 9.7 months due to pre-determined criteria of vaginal mesh exposure in 5/32 patients (15.6%) in the mesh arm.
Participant milestones
| Measure |
Prolift Mesh
vaginal prolapse repair with anterior or total mesh
synthetic monofilament polypropylene mesh: Vaginal prolapse repair with mesh
|
Prolapse Repair Without Mesh
vaginal prolapse repair without mesh (native tissue repair)
|
|---|---|---|
|
3 Months
STARTED
|
32
|
33
|
|
3 Months
COMPLETED
|
32
|
33
|
|
3 Months
NOT COMPLETED
|
0
|
0
|
|
12 Months
STARTED
|
32
|
33
|
|
12 Months
COMPLETED
|
32
|
33
|
|
12 Months
NOT COMPLETED
|
0
|
0
|
|
36 Months
STARTED
|
33
|
32
|
|
36 Months
COMPLETED
|
25
|
26
|
|
36 Months
NOT COMPLETED
|
8
|
6
|
Reasons for withdrawal
| Measure |
Prolift Mesh
vaginal prolapse repair with anterior or total mesh
synthetic monofilament polypropylene mesh: Vaginal prolapse repair with mesh
|
Prolapse Repair Without Mesh
vaginal prolapse repair without mesh (native tissue repair)
|
|---|---|---|
|
36 Months
Lost to Follow-up
|
4
|
4
|
|
36 Months
Death
|
1
|
2
|
|
36 Months
Censored due to reoperation
|
3
|
0
|
Baseline Characteristics
Efficacy Study of Vaginal Mesh for Prolapse
Baseline characteristics by cohort
| Measure |
Prolift Mesh
n=25 Participants
vaginal prolapse repair with anterior or total mesh
synthetic monofilament polypropylene mesh: Vaginal prolapse repair with mesh
|
Prolapse Repair Without Mesh
n=26 Participants
vaginal prolapse repair without mesh (native tissue repair)
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.6 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
63.1 years
STANDARD_DEVIATION 9 • n=7 Participants
|
62.8 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
16 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
6 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Postmenopausal
|
23 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Parity
|
2 number deliveries
n=5 Participants
|
2 number deliveries
n=7 Participants
|
2 number deliveries
n=5 Participants
|
|
BMI
|
27.6 kg/m^2
STANDARD_DEVIATION 5.5 • n=5 Participants
|
28.2 kg/m^2
STANDARD_DEVIATION 6.4 • n=7 Participants
|
27.9 kg/m^2
STANDARD_DEVIATION 6.0 • n=5 Participants
|
|
POP-Q stage
stage 2
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
POP-Q stage
stage 3
|
16 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
34 Participants
n=5 Participants
|
|
POP-Q stage
stage 4
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
married
|
16 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
education
High school or less
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
education
completed high school
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
education
college or graduate
|
21 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
insurance
Private
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
insurance
medicare
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
hysterectomy
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
prior prolapse surgery
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
prior incontinence surgery
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 3 year3 different measures for Anatomic cure using POPQ measurements: 1. POP-Q at Stage I or less\* (POP-Q points Ba, Bp or C -1 or less); 2. no prolapse beyond the hymen (Ba, Bp or C 0 or less); 3. no prolapse beyond the hymen (Ba, Bp 0 or less) with adequate apical support above the midvagina (C to TVL/2 or less) No bulge symptoms using Pelvic Floor Distress Inventory, PFDI question 3; do you see or feel a bulge in the vaginal area with response of no. Patient Satisfaction using Patient Global Impression of Improvement with response of very much better or much better
Outcome measures
| Measure |
Prolift Mesh
n=25 Participants
vaginal prolapse repair with mesh
synthetic monofilament polypropylene mesh: Vaginal prolapse repair with mesh
|
Prolapse Repair Without Mesh
n=26 Participants
vaginal prolapse repair without mesh
synthetic monofilament polypropylene mesh: Vaginal prolapse repair with mesh
|
|---|---|---|
|
Number of Participants With Anatomic Cure at 3 Years
no reoperation/retreatment
|
20 Participants
|
21 Participants
|
|
Number of Participants With Anatomic Cure at 3 Years
composite stage less than/equal 1, no bulge symptoms, satisfaction very much better or much better
|
8 Participants
|
8 Participants
|
|
Number of Participants With Anatomic Cure at 3 Years
composite no prolapse beyond hymen, no bulge symptoms, satisfaction very much better or much better
|
15 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: 3 yearPelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire question 5 response of usually or always and tracked resolution, persistence, de novo dyspareunia
Outcome measures
| Measure |
Prolift Mesh
n=14 Participants
vaginal prolapse repair with mesh
synthetic monofilament polypropylene mesh: Vaginal prolapse repair with mesh
|
Prolapse Repair Without Mesh
n=11 Participants
vaginal prolapse repair without mesh
synthetic monofilament polypropylene mesh: Vaginal prolapse repair with mesh
|
|---|---|---|
|
Bothersome Dyspareunia
Persistent dyspareunia
|
5 Participants
|
5 Participants
|
|
Bothersome Dyspareunia
resolution dyspareunia
|
2 Participants
|
1 Participants
|
|
Bothersome Dyspareunia
de novo dyspareunia
|
2 Participants
|
1 Participants
|
Adverse Events
Prolift Mesh
Prolapse Repair Without Mesh
Serious adverse events
| Measure |
Prolift Mesh
n=32 participants at risk
vaginal prolapse repair with mesh
synthetic monofilament polypropylene mesh: Vaginal prolapse repair with mesh
|
Prolapse Repair Without Mesh
n=33 participants at risk
vaginal prolapse repair without mesh
synthetic monofilament polypropylene mesh: Vaginal prolapse repair with mesh
|
|---|---|---|
|
Surgical and medical procedures
Surgery/reoperation for mesh exposure
|
15.6%
5/32 • Number of events 5 • 3 months, 1 year, 3 years
|
0.00%
0/33 • 3 months, 1 year, 3 years
|
Other adverse events
| Measure |
Prolift Mesh
n=32 participants at risk
vaginal prolapse repair with mesh
synthetic monofilament polypropylene mesh: Vaginal prolapse repair with mesh
|
Prolapse Repair Without Mesh
n=33 participants at risk
vaginal prolapse repair without mesh
synthetic monofilament polypropylene mesh: Vaginal prolapse repair with mesh
|
|---|---|---|
|
Surgical and medical procedures
suture exposure
|
0.00%
0/32 • 3 months, 1 year, 3 years
|
15.2%
5/33 • Number of events 5 • 3 months, 1 year, 3 years
|
Additional Information
Allie Moses, Manager, Clinical Research Systems and Recruitment Center
MedStar Health Research Institute
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place