Mesh vs Suture Techniques for Pelvic Organ Prolapse

(COMET Trial)

Overseen By Nicole Koenig

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Chronic steroids

Disqualifiers: Prior pelvic radiation, Immune compromise, Current smoker, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 7

Duration: 6 weeks

358 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment BSSVF-M Procedure, SSLS Procedure for pelvic organ prolapse?

Research shows that using anterior vaginal mesh combined with sacrospinous ligament fixation (SSF) has better long-term success rates for treating advanced pelvic organ prolapse compared to other methods, with low complication rates. Additionally, both unilateral and bilateral sacrospinous ligament fixation techniques are considered safe and effective for treating pelvic organ prolapse. ^{1 2 3 4 5}

Is the Mesh vs Suture Technique for Pelvic Organ Prolapse safe?

The sacrospinous ligament fixation (SSLF) procedure, whether using mesh or native tissue, is generally considered safe with low rates of serious complications and recurrence. Studies show that both unilateral and bilateral SSLF techniques have similar safety profiles, and the use of mesh may reduce the risk of needing another surgery for recurrence. ^{1 5 6 7 8}

How does the BSSVF-M and SSLS treatment for pelvic organ prolapse differ from other treatments?

The BSSVF-M and SSLS treatment for pelvic organ prolapse is unique because it combines mesh and suture techniques, potentially offering better long-term success rates compared to traditional suture-only methods, with a low rate of complications. This approach may provide improved anatomical support and durability for patients with advanced pelvic organ prolapse. ^{1 3 5 9 10}

Eligibility Criteria

This trial is for women over 19 with bothersome pelvic organ prolapse, who can read and write in English, and commit to follow-up visits for two years. It excludes pregnant or breastfeeding women, those with prior vaginal mesh surgery or pelvic radiation, immune-compromised individuals, current smokers, and those with certain pain syndromes.

Inclusion Criteria

You have a condition called pelvic organ prolapse that is causing discomfort and affects the top of your vagina.

Women over 19 years of age

Able to read and write in English

Exclusion Criteria

Currently pregnant or breastfeeding

You have had surgery with vaginal mesh for prolapse in the past.

You have a weakened immune system or take steroids regularly.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo either BSSVF-M or SSLS surgery for pelvic organ prolapse

6 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Visits at 6 weeks, 6 months, 12 months, and 24 months (in-person and phone)

Long-term Follow-up

Participants' health benefits and costs of surgery are estimated using a Markov model

10 years

Treatment Details

Interventions

• BSSVF-M Procedure
• SSLS Procedure

Trial Overview The study compares two surgical techniques for pelvic organ prolapse repair: BSSVF-M using synthetic mesh vs. SSLS using sutures. The goal is to assess which method offers better success and cost-effectiveness over a period of two years while keeping patients unaware of the technique used.

Participant Groups

Group I: SSLS Procedure Active Control 1 Intervention

Group II: BSSVF-M Procedure Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Centre for Health Evaluation and Outcome Sciences

Collaborator

Trials

2

Recruited

930+

University of Alberta

Collaborator

Trials

957

Recruited

437,000+

McGill University

Collaborator

Trials

421

Recruited

1,017,000+

McMaster University

Collaborator

Trials

936

Recruited

2,630,000+

References

1. England pubmed.ncbi.nlm.nih.gov

Long-term outcomes of synthetic transobturator nonabsorbable anterior mesh versus anterior colporrhaphy in symptomatic, advanced pelvic organ prolapse surgery. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

A multicenter, randomized, prospective, controlled study comparing sacrospinous fixation and transvaginal mesh in the treatment of posthysterectomy vaginal vault prolapse. [2022]

3. France pubmed.ncbi.nlm.nih.gov

Comparison of two natural tissue repair-based surgical techniques; sacrospinous fixation and uterosacral ligament suspension for pelvic organ prolapse treatment. [2021]

4. United States pubmed.ncbi.nlm.nih.gov

Posterior Intravaginal Slingplasty versus Unilateral Sacrospinous Ligament Fixation in Treatment of Vaginal Vault Prolapse. [2021]

5. Germany pubmed.ncbi.nlm.nih.gov

Comparison of Unilateral and Bilateral Sacrospinous Ligament Fixation Using Minimally Invasive Anchorage. [2020]

6. England pubmed.ncbi.nlm.nih.gov

Anterior bilateral sacrospinous ligament fixation with concomitant anterior native tissue repair: a pilot study. [2023]

7. China pubmed.ncbi.nlm.nih.gov

Unilateral sacrospinous ligament fixation for treatment of genital prolapse. [2010]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Serious Complications and Recurrence following Sacrospinous Ligament Fixation for the Correction of Apical Prolapse. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Factors that affect outcomes of prolapse repair using single-incision vaginal mesh procedures. [2019]

10. China pubmed.ncbi.nlm.nih.gov

Function, quality-of-life and complications after sacrospinous ligament fixation using an antegrade reusable suturing device (ARSD-Ney) at 6 and 12 months: a retrospective cohort study. [2022]