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Composite Outcomes of Mesh vs Suture Techniques for Prolapse Repair: A Randomized Controlled Multicentre Trial
Sponsor: University of British Columbia
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
Conditions
Interventions
SSLS Procedure
Synthetic suture repair
BSSVF-M Procedure
Bilateral sacrospinous vaginal vault fixation with synthetic mesh arms
Locations (1)
St. Paul's Hospital
Vancouver, British Columbia, Canada