N/A
N=65
Efficacy Study of Vaginal Mesh for Prolapse
Pelvic Organ Prolapse · Uterine Prolapse · Vaginal Prolapse · Cystocele · Rectocele
Bottom Line
View on ClinicalTrials.gov: NCT00475540 ↗Enrolled (actual)
65
Serious AEs
7.7%
Results posted
Oct 2022
Primary outcome: Primary: Number of Participants With Anatomic Cure at 3 Years — 20; 21; 8; 8 Participants — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- synthetic monofilament polypropylene mesh (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- Female
- Sponsor
- Medstar Health Research Institute
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Anatomic Cure at 3 Years |
20; 21; 8; 8; 15; 12 | <0.05 sig |
| SECONDARY Bothersome Dyspareunia |
5; 5; 2; 1; 2; 1 | — |
Summary
The primary aim of this double-blind, randomized clinical trial (RCT) is to test the hypothesis that the addition of a standardized technique of interpositional synthetic polypropylene mesh placement improves the one-year outcome of vaginal reconstructive surgery for pelvic organ prolapse compared to traditional vaginal reconstructive surgery without mesh.
Eligibility Criteria
Inclusion Criteria
- Woman > 21 yrs
- Stage II-IV vaginal prolapse
- Desires vaginal reconstructive surgery
- Able to complete study questionnaires and assessments
- Uterus < 12 weeks size
- Available for 12 months follow-up
Exclusion Criteria
- Medical contraindications, e.g. current urinary tract, vaginal or pelvic infection, history of pelvic irradiation, history of lower urinary tract malignancy, chronic steroid use or a compromised immune system.
- Current intermittent catheterization.
- Pregnancy or desire for future fertility.
- Presence of an adnexal mass.
- Shortened vagina or other known Mullerian anomaly (e.g. uterine didelphys).
- Other laparoscopic or abdominal/pelvic surgery in the past 3 months.
- Known neurologic or medical condition affecting bladder function, e.g. Multiple Sclerosis, spinal cord injury.
- Need for concomitant surgery requiring an abdominal incision.
- < 12 months post-partum.
- Non-english speaking
Data sourced from ClinicalTrials.gov (NCT00475540). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.