Efficacy Study of Vaginal Mesh for Prolapse

Pelvic Organ Prolapse Clinical Trial

— VAMP  

Official title:

A Randomized Clinical Trial of Vaginal Mesh for Prolapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475540
• Other study ID #: 2006-232
• Status: Completed
• Phase: N/A
• Start date: January 2007
• Est. completion date: August 2013

Study information

• Verified date: July 2022
• Source: Medstar Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: August 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cystocele
• Pelvic Organ Prolapse
• Prolapse
• Rectocele
• Uterine Prolapse
• Vaginal Prolapse

Intervention

Device:
• synthetic monofilament polypropylene mesh
Vaginal prolapse repair with mesh

Locations

Country	Name	City	State
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Medstar Health Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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