Composite Outcomes of Mesh vs Suture Techniques for Prolapse Repair: A Randomized Controlled Mult… (NCT02965313) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Composite Outcomes of Mesh vs Suture Techniques for Prolapse Repair: A Randomized Controlled Multicentre Trial
Canada358 participantsStarted 2016-11
Plain-language 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.
Who can participate
Age range19 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Women over 19 years of age
✓. Able to read and write in English
✓. Able to follow up with clinic visits for up to two years after surgery
✓. Diagnosed with bothersome pelvic organ prolapse including at the top of the vagina
Exclusion criteria
✕. Women who wish to conserve the uterus
✕. Prior pelvic radiation
✕. Prior vaginal mesh surgery for prolapse
✕. Prior vaginal mesh exposure
✕. Presence of vaginal pain from pelvic floor muscle spasm documented at baseline visit
✕. Plan for synthetic vaginal mesh insertion for prolapse, at the same time, at locations other than the top of the vagina (NOTE: concurrent need for synthetic anti-incontinence sling is NOT an exclusion)
What they're measuring
1
Composite outcome of 3 objective signs and 1 subjective symptom of POP (yes/no answers). The definition of surgical success, used in the OPTIMAL trial as described in the description below.