Composite Outcomes of Mesh vs Suture Techniques for Prolapse Repair: A Randomized Controlled Multicentre Trial (NCT02965313)
Vaginal Surgery for the Pelvic Floor: A Randomized Trial of Synthetic Mesh Versus Synthetic Sutures
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: St. Paul's Hospital — Vancouver, British Columbia
Age range: 19 Years
🧪 Interventions in This Study
- SSLS Procedure (PROCEDURE)
- BSSVF-M Procedure (PROCEDURE)
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (1 Sites)
- St. Paul's Hospital — Vancouver, British Columbia
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Pelvic Organ Prolapse
- POMEGRANATE Trial: Comparing Reia Pessary Versus Standard of Care Pessary for Pelvic Organ Prolapse Treatment — Birmingham, Alabama
- Intraoperative Costs and Patient Perceptions in Sacrocolpopexy for Prolapse — Rochester, Minnesota
- Vaginal Orthosis Use After Vaginal Reconstructive Surgery — Birmingham, Alabama
- Platelet Rich Plasma as an Adjunct Therapy at the Time of Transvaginal Native Tissue Prolapse Surgery — Birmingham, Alabama
- Pessary Experience Study — Charlottesville, Virginia
Explore by condition: All Pelvic Organ Prolapse clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.