Efficacy Study of Vaginal Mesh for Prolapse

Not Applicable

Completed

Conditions: Rectocele
Uterine Prolapse
Vaginal Prolapse
Cystocele
Pelvic Organ Prolapse

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.

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Prolift mesh	synthetic monofilament polypropylene mesh	vaginal prolapse repair with mesh
Prolapse repair without mesh	synthetic monofilament polypropylene mesh	vaginal prolapse repair without mesh

Primary Outcome Measures

Name	Time	Method
Number of Participants With Anatomic Cure at 3 Years	3 year	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

Secondary Outcome Measures

Name	Time	Method
Bothersome Dyspareunia	3 year	Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire question 5 response of usually or always and tracked resolution, persistence, de novo dyspareunia