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Minimally Invasive Sacrocolpopexy for Pelvic Organ Prolapse (MERIT Trial)
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Waitlist Available
Research Sponsored by University of Pittsburgh
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Planning a surgical repair of POP with minimally invasive sacrocolpopexy
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6, 12 months postoperatively
Awards & highlights
MERIT Trial Summary
This trial is looking at whether narrowing the enlarged genital hiatuses (holes) during minimally invasive sacrocolpopexy surgery can help reduce pelvic organ prolapse in women. The study will follow women for 6 months to see if their condition has improved.
Who is the study for?
This trial is for women with pelvic organ prolapse who have a genital hiatus size between 4.0 and 7.5cm and are planning to undergo minimally invasive sacrocolpopexy surgery.Check my eligibility
What is being tested?
The study compares the effect of adding a Level III support procedure at the end of a sacrocolpopexy surgery on reducing enlarged genital hiatuses, using transperineal ultrasound to measure outcomes.See study design
What are the potential side effects?
Potential side effects may include discomfort or complications from surgical procedures such as posterior colporrhaphy or perineorrhaphy, and risks associated with minimally invasive surgeries.
MERIT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am planning a minimally invasive surgery for pelvic organ prolapse.
MERIT Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6, 12 months postoperatively
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 12 months postoperatively
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Enlarged Genital Hiatus at 6 months postoperatively
Secondary outcome measures
Composite prolapse recurrence
Dyspareunia postoperatively
Levator Hiatal Area
+3 moreMERIT Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: SacrocolpopexyExperimental Treatment2 Interventions
This group will only receive the sacrocolpopexy for their pelvic organ prolapse repair.
Group II: Sacrocolpopexy and concomitant level III support procedureActive Control3 Interventions
This randomized group will receive an additional vaginal repair for level III support at the conclusion of the sacrocolpopexy.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Pelvic Organ Prolapse (POP) treatments, such as Posterior Colporrhaphy and Perineorrhaphy, work by surgically narrowing the genital hiatus to restore normal pelvic anatomy. These procedures involve suturing the posterior vaginal wall and perineal body to provide better support to the pelvic organs.
This is important for POP patients as it can alleviate symptoms like vaginal bulging, discomfort, and urinary incontinence, thereby improving their overall quality of life.
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Who is running the clinical trial?
University of PittsburghLead Sponsor
1,731 Previous Clinical Trials
16,307,342 Total Patients Enrolled
3 Trials studying Pelvic Organ Prolapse
392 Patients Enrolled for Pelvic Organ Prolapse
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Your genital hiatus measurement before surgery needs to be between 4.0 and 7.5cm.I am planning a minimally invasive surgery for pelvic organ prolapse.I am a woman with pelvic organ prolapse.
Research Study Groups:
This trial has the following groups:- Group 1: Sacrocolpopexy
- Group 2: Sacrocolpopexy and concomitant level III support 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.
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