Efficacy Study of Vaginal Mesh for Prolapse (VAMP)

MedStar Health

Status: Completed

Conditions: Uterine Prolapse; Cystocele; Vaginal Prolapse; Pelvic Organ Prolapse; Rectocele

Treatments: Device: synthetic monofilament polypropylene mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT00475540

2006-232

Details and patient eligibility

About

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.

Full 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.

Enrollment: 65 patients

Sex: Female

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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65 participants in 2 patient groups

Prolift mesh

Active Comparator group

Description:

vaginal prolapse repair with mesh

Treatment:

Device: synthetic monofilament polypropylene mesh

Prolapse repair without mesh

Active Comparator group

Description:

vaginal prolapse repair without mesh

Treatment:

Device: synthetic monofilament polypropylene mesh