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ACTIVE NOT RECRUITING
NCT02965313
NA

Composite Outcomes of Mesh vs Suture Techniques for Prolapse Repair: A Randomized Controlled Multicentre Trial

Sponsor: University of British Columbia

View on ClinicalTrials.gov

Summary

This is a Canadian, multi-centre, double-blind randomized controlled trial of an innovative vaginal surgery technique for correction of pelvic organ prolapse (POP) in women. Vaginal surgery is preferred as minimally invasive, however the investigators do not know if materials such as synthetic polypropylene mesh improve success, durability and cost-effectiveness long-term. The investigators principal goal is to compare the experimental bilateral sacrospinous vaginal vault fixation with synthetic mesh arms (BSSVF-M) to the current standard of sacrospinous ligament suspension with synthetic sutures (SSLS) over a timeline of 2 years. Patients and evaluators will be blind to technique.

Official title: Vaginal Surgery for the Pelvic Floor: A Randomized Trial of Synthetic Mesh Versus Synthetic Sutures

Key Details

Gender

FEMALE

Age Range

19 Years - Any

Study Type

INTERVENTIONAL

Enrollment

358

Start Date

2016-11

Completion Date

2026-11

Last Updated

2024-10-15

Healthy Volunteers

No

Interventions

PROCEDURE

SSLS Procedure

Synthetic suture repair

PROCEDURE

BSSVF-M Procedure

Bilateral sacrospinous vaginal vault fixation with synthetic mesh arms

Locations (1)

St. Paul's Hospital

Vancouver, British Columbia, Canada