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

NCT02965313 | Active Not Recruiting DMC

• 1 other identifier: H16-02085
• Study Type: interventional
• Target: 358
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (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.

  The Optimal Trial Outcome is the absence of all the following: (1) objectively recorded, via POP quantification (POP-Q)15, recurrent POP of the top of the vagina beyond the upper third of the vaginal canal; (2) objectively recorded, via POPQ, recurrent POP of the anterior or posterior vaginal walls beyond the hymenal ring (vaginal entrance); (3) vaginal bulge symptoms reported by the patient, as indicated by an affirmative response to either: "Do you usually have a bulge or something falling out that you can see or feel in the vaginal area?" and any response other than "not at all" to the question "How much does that bother you?" (4) re-treatment for prolapse by either surgery or pessary (conservative treatment with insertion of a silicone ring in the vagina for support). The POPQ is a validated quantification system with adequate interrater reliability which measures, in centimeters, the extent of vaginal wall descent with respect to a reference point at the hymenal ring.

  2 years postoperatively

Secondary Outcomes (12)

• Change in maximal POP of vaginal compartments via POPQ, obtained by research personnel (nurse or clinical fellow) trained in POPQ and blinded to group allocation. POP will be quantified and compared to baseline.

  Baseline to 6 weeks,12 and 24 months

• Change in questionnaire scores between the 2 groups from baseline to 6 weeks, 12 and 24 months postoperatively: Pelvic Floor Distress Inventory (PFDI-20)

  Baseline to 6 weeks,12 and 24 months

• Change in questionnaire scores between the 2 groups from baseline to 6 weeks, 12 and 24 months postoperatively: Pelvic Floor Impact Questionnaire (PFIQ-7)

  Baseline to 6 weeks, 12 and 24 months

• Change in questionnaire scores between the 2 groups from baseline to 6 weeks, 12 and 24 months postoperatively: the short form McGill pain questionnaire

  Baseline to 6 weeks, 12 and 24 months

• Change in questionnaire scores between the 2 groups from baseline to 6 weeks, 12 and 24 months postoperatively: the a validated gender-specific body image scale specifically for POP (BIPOP) Questionnaire

  Baseline to 6 weeks, 12 and 24 months

Other Outcomes (1)

• Health economic evaluation

  6 weeks, 6, 12 and 24 months postoperatively

Study Arms (2)

SSLS Procedure

ACTIVE COMPARATOR

Procedure: BSSVF-M Procedure

BSSVF-M Procedure

ACTIVE COMPARATOR

Procedure: SSLS Procedure

Interventions

SSLS Procedure PROCEDURE

Synthetic suture repair

BSSVF-M Procedure

BSSVF-M Procedure PROCEDURE

Bilateral sacrospinous vaginal vault fixation with synthetic mesh arms

SSLS Procedure

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Immune compromise; chronic steroid use
• Current smoker
• Currently pregnant or breastfeeding
• Presence of pain syndromes likely to cause a heightened sensitivity to pelvic pain (IE fibromyalgia or painful bladder syndrome)

Sponsors & Collaborators

• Centre for Advancing Health Outcomes: collaborator
• University of British Columbia: lead
• University of Alberta: collaborator
• McGill University: collaborator
• McMaster University: collaborator

Study Sites (1)

St. Paul's Hospital

Vancouver, British Columbia, V6Z 2K5, Canada

Location

Related Publications (1)

• Roa L, Larouche M, Hyakutake M, Brennand EA, Malabarey O, Koenig N, Lee T, Singer J, Zhang W, Brotto LA, Geoffrion R. COMET (Composite Outcomes of Mesh vs suture Techniques for prolapse repair)- Protocol for a single blind randomized controlled multicenter trial testing surgical innovation in female pelvic surgery. PLoS One. 2024 Oct 24;19(10):e0308926. doi: 10.1371/journal.pone.0308926. eCollection 2024.

  PMID: 39446736 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Roxana Geoffrion

Study Record Dates

• First Submitted: November 8, 2016
• First Posted: November 16, 2016
• Study Start: November 1, 2016
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Locations

CA (1)