Efficacy Study of Vaginal Mesh for Prolapse

Study Overview
=================
Brief 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.

Detailed Description
-----------------
Minimally invasive surgical procedures using mesh have rapidly developed in the field of pelvic floor reconstruction. Unfortunately, safety and efficacy data have lagged behind the technical advancements. No randomized controlled trials of different vaginal apical suspension procedures have been reported. The use of synthetic vaginal mesh has evolved due to the 20-30% recurrence rate for conventional pelvic reconstructive surgeries. This trial will examine synthetic monofilament polypropylene mesh use in vaginal reconstructive surgery for vaginal Stage II-IV prolapse.

Official Title
-----------------
A Randomized Clinical Trial of Vaginal Mesh for Prolapse

Conditions
-----------------
Pelvic Organ Prolapse, Uterine Prolapse, Vaginal Prolapse, Cystocele, Rectocele

Intervention / Treatment
-----------------
* Device: synthetic monofilament polypropylene mesh


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Prolift mesh<br>vaginal prolapse repair with mesh | Device: synthetic monofilament polypropylene mesh<br>* Vaginal prolapse repair with mesh<br>* Other names: Prolift;|
| Active Comparator: Prolapse repair without mesh<br>vaginal prolapse repair without mesh | Device: synthetic monofilament polypropylene mesh<br>* Vaginal prolapse repair with mesh<br>* Other names: Prolift;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Anatomic Cure at 3 Years | 3 different measures for Anatomic cure using POPQ measurements: POP-Q at Stage I or less* (POP-Q points Ba, Bp or C -1 or less); no prolapse beyond the hymen (Ba, Bp or C 0 or less); 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 | 3 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bothersome Dyspareunia | Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire question 5 response of usually or always and tracked resolution, persistence, de novo dyspareunia | 3 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prolapse, uterus, pelvic organ, vaginal prolpase