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Mesh
SSLS Procedure for Pelvic Organ Prolapse (COMET Trial)
N/A
Recruiting
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years postoperatively
Awards & highlights
COMET Trial Summary
This trial is to compare two different types of vaginal surgery for correcting pelvic organ prolapse in women. One type uses mesh and the other doesn't, and they want to see which is better.
Eligible Conditions
- Pelvic Organ Prolapse
COMET Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years postoperatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years postoperatively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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.
Secondary outcome measures
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.
Change in questionnaire scores between the 2 groups from baseline to 12 and 24 months: Pelvic organ prolapse/ Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)
Change in questionnaire scores between the 2 groups from baseline to 6 weeks, 12 and 24 months postoperatively: Pelvic Floor Distress Inventory (PFDI-20)
+9 moreOther outcome measures
Health economic evaluation
COMET Trial Design
2Treatment groups
Active Control
Group I: SSLS ProcedureActive Control1 Intervention
Group II: BSSVF-M ProcedureActive Control1 Intervention
Find a Location
Logistics
Travel, including flights, are covered
Your expenses for travel tickets for this trial will be reimbursed.
Who is running the clinical trial?
University of British ColumbiaLead Sponsor
1,413 Previous Clinical Trials
2,466,603 Total Patients Enrolled
1 Trials studying Pelvic Organ Prolapse
100 Patients Enrolled for Pelvic Organ Prolapse
Centre for Health Evaluation and Outcome SciencesUNKNOWN
1 Previous Clinical Trials
576 Total Patients Enrolled
University of AlbertaOTHER
886 Previous Clinical Trials
384,420 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had surgery with vaginal mesh for prolapse in the past.You have a weakened immune system or take steroids regularly.You have a condition called pelvic organ prolapse that is causing discomfort and affects the top of your vagina.You have conditions like fibromyalgia or painful bladder syndrome that may make pelvic pain worse.Women who want to keep their uterus intact.You have received radiation treatment in your pelvic area before.You currently smoke cigarettes.You have had a vaginal mesh implanted before.You have documented pain in your vagina caused by tight pelvic floor muscles.You are planning to have a synthetic vaginal mesh inserted to treat prolapse, but not at the top of the vagina. (Note: If you also need a synthetic sling to treat incontinence, it is not an exclusion.)
Research Study Groups:
This trial has the following groups:- Group 1: SSLS Procedure
- Group 2: BSSVF-M Procedure
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is enrollment for this clinical research study still open to participants?
"According to the clinicaltrials.gov listing, this clinical study is actively seeking participants; it was initially posted on November 1st 2016 and last revised on May 17th 2022."
Answered by AI
How many participants is the upper limit to join this research experiment?
"Affirmative. Clinicaltrials.gov's records suggest that this experiment is still recruiting patients, having been first posted on November 1st 2016 and most recently revised on May 17th 2022. A total of 358 participants are required from a single site for the trial to be completed successfully."
Answered by AI
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