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

NCT02965313 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 358

Last updated 2026-05-01

No results posted yet for this study

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.

Conditions

  • Pelvic Organ Prolapse

Interventions

PROCEDURE

SSLS Procedure

Synthetic suture repair

PROCEDURE

BSSVF-M Procedure

Bilateral sacrospinous vaginal vault fixation with synthetic mesh arms

Sponsors & Collaborators

  • University of Alberta

    collaborator OTHER

  • McGill University

    collaborator OTHER

  • McMaster University

    collaborator OTHER

  • Centre for Advancing Health Outcomes

    collaborator UNKNOWN

  • University of British Columbia

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2026-11-30
Completion
2026-11-30

Countries

  • Canada

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02965313 on ClinicalTrials.gov