Mesh vs Suture Techniques for Pelvic Organ Prolapse
(COMET Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests two surgical techniques for treating pelvic organ prolapse (POP), a condition where organs like the bladder or uterus drop from their normal position. Researchers compare a procedure using synthetic mesh (BSSVF-M Procedure) to one using traditional sutures (SSLS Procedure) to determine which is more effective and durable over two years. Women with bothersome prolapse symptoms at the top of the vagina who can attend follow-up visits for up to two years might be suitable candidates. As an unphased trial, this study allows patients to contribute to important research that could enhance future treatment options for POP.
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 prior data suggests that these surgical techniques are safe for pelvic organ prolapse correction?
Research has shown that the BSSVF-M procedure, which uses a special synthetic mesh, succeeded in 77% of women after one year, based on an initial study. The procedure is considered safe and can be easily taught to other surgeons. Another study found that using a small amount of mesh improved results for patients with severe prolapse without major safety concerns.
For the SSLS procedure, which uses synthetic stitches, studies indicate it is a safe and effective way to repair pelvic organ prolapse. Short-term results have been positive, and long-term data suggest it effectively reduces prolapse symptoms over time.
Both treatments appear well-tolerated, with no major safety issues reported in these studies.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it compares two different techniques for addressing pelvic organ prolapse: the BSSVF-M Procedure and the SSLS Procedure. Unlike traditional methods that focus on either stitching (suture) or using synthetic mesh, this trial aims to identify which approach provides better outcomes in terms of effectiveness and safety. The BSSVF-M Procedure involves using a mesh, which might offer longer-lasting support and potentially reduce recurrence rates. On the other hand, the SSLS Procedure uses sutures, which could minimize complications sometimes associated with mesh use. By directly comparing these two approaches, researchers hope to pinpoint the best technique to improve quality of life for patients with pelvic organ prolapse.
What evidence suggests that this trial's techniques could be effective for pelvic organ prolapse?
In this trial, participants will be assigned to one of two procedures for pelvic organ prolapse. Research has shown that the BSSVF-M procedure, which uses synthetic mesh, succeeded in 77% of women after one year. It is considered safe and easy for surgeons to perform. Women who underwent this procedure experienced fewer complications after surgery, required less pain medication, and had shorter hospital stays.
In contrast, the SSLS procedure, also tested in this trial, uses synthetic stitches and effectively repairs pelvic organ prolapse (POP). Long-term results have shown improvements in various POP-related issues, and it has proven safe and effective for severe prolapse cases. Both procedures aim to fix prolapse but use different materials and techniques.16789Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo either BSSVF-M or SSLS surgery for pelvic organ prolapse
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term Follow-up
Participants' health benefits and costs of surgery are estimated using a Markov model
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Active Control
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of British Columbia
Lead Sponsor
Centre for Health Evaluation and Outcome Sciences
Collaborator
University of Alberta
Collaborator
McGill University
Collaborator
McMaster University
Collaborator
Citations
COMET (Composite Outcomes of Mesh vs suture ...
The results of this multi-center randomized controlled trial will provide data on short-term, composite medium-term outcomes, and economic impact of BSSVF-M ...
Composite Outcomes of Mesh vs Suture Techniques for ...
An exploratory prospective cohort study followed, showing BSSVF-M to be safe, easily taught to other surgeons and successful in 77% of women at one year, with ...
COMET (Composite Outcomes of Mesh vs suture ...
This is a multi-center randomized controlled trial in Canada comparing the surgical techniques of BSSVF-M vs. SSLS to address apical prolapse.
Bilateral Sacrospinous Vault Fixation With Tailored ...
Women who underwent bSSVF had more anterior recurrences but fewer postoperative complications, shorter hospital stay, and less use of narcotics than controls.
5.
researchgate.net
researchgate.net/publication/273463914_Bilateral_Sacrospinous_Vault_Fixation_With_Tailored_Synthetic_Mesh_Arms_Clinical_Outcomes_at_One_YearBilateral Sacrospinous Vault Fixation With Tailored ...
Global satisfaction was recorded. The primary outcome measure was the difference in cure rate (vault stage ≤ 1) between groups. Results: Fifty ...
Short-term outcomes of the transvaginal minimal mesh ...
In this retrospective study, we found that our minimal mesh TVM procedure significantly improved anatomical outcomes in patients with severe prolapse at one ...
7.
researchgate.net
researchgate.net/publication/283323371_Vaginal_Mesh_in_Pelvic_Reconstructive_Surgery_Controversies_Current_Use_and_ComplicationsVaginal Mesh in Pelvic Reconstructive Surgery
Prospective long-term results, complications and risk factors in pelvic organ prolapse treatment with vaginal mesh. Article. Feb 2017.
Long-term outcomes of pelvic organ prolapse repair using a ...
The aim of this study was to compare long-term effects of high-volume surgery at a single-center to multicenter use when using a mesh-capturing device for ...
Vaginal reconstruction effectiveness and safety
Excellent anatomical and quality of life outcomes were seen in patients treated with the seratom PA MR MN® mini-mesh system for POP, according to this current ...
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