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Procedure

Minimally Invasive Sacrocolpopexy for Pelvic Organ Prolapse (MERIT Trial)

N/A
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 below
Select...
I am planning a minimally invasive surgery for pelvic organ prolapse.

MERIT Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6, 12 months postoperatively
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6, 12 months postoperatively for reporting.

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 more

MERIT 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.

Find a Location

Who is running the clinical trial?

University of PittsburghLead Sponsor
1,719 Previous Clinical Trials
16,342,247 Total Patients Enrolled
3 Trials studying Pelvic Organ Prolapse
392 Patients Enrolled for Pelvic Organ Prolapse

Media Library

Minimally Invasive Sacrocolpopexy (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04480671 — N/A
Pelvic Organ Prolapse Research Study Groups: Sacrocolpopexy, Sacrocolpopexy and concomitant level III support procedure
Pelvic Organ Prolapse Clinical Trial 2023: Minimally Invasive Sacrocolpopexy Highlights & Side Effects. Trial Name: NCT04480671 — N/A
Minimally Invasive Sacrocolpopexy (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04480671 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available openings to participate in this scientific experiment?

"Per clinicaltrials.gov, the recruitment period for this trial has concluded as of October 24th 2022. The study was initially posted on August 26 2020 and is no longer seeking participants; however, 78 other trials are still enrolling patients at present."

Answered by AI
Recent research and studies
American Journal of Obstetrics and GynecologyJournal
Robotic-assisted Sacrocolpopexy: Early Postoperative Outcomes After Surgical Reduction of Enlarged Genital Hiatus
Bradley, Megan S., Amy L. Askew, Monique H. Vaughan, Amie Kawasaki, and Anthony G. Visco. 2018. “Robotic-assisted Sacrocolpopexy: Early Postoperative Outcomes After Surgical Reduction of Enlarged Genital Hiatus”. American Journal of Obstetrics and Gynecology. Elsevier BV. doi:10.1016/j.ajog.2018.01.046.
Female Pelvic Medicine & Reconstructive SurgeryJournal
Outcomes of Abdominal and Minimally Invasive Sacrocolpopexy
Nosti, Patrick A., Uduak Umoh Andy, Sarah Kane, Dena E. White, Heidi S. Harvie, Lior Lowenstein, and Robert E. Gutman. 2014. “Outcomes of Abdominal and Minimally Invasive Sacrocolpopexy”. Female Pelvic Medicine & Reconstructive Surgery. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/spv.0000000000000036.
Obstetrics & GynecologyJournal
Surgical Alteration of Genital Hiatus Size and Anatomic Failure After Vaginal Vault Suspension
Vaughan, Monique H., Nazema Y. Siddiqui, Laura K. Newcomb, Alison C. Weidner, Amie Kawasaki, Anthony G. Visco, and Megan S. Bradley. 2018. “Surgical Alteration of Genital Hiatus Size and Anatomic Failure After Vaginal Vault Suspension”. Obstetrics & Gynecology. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/aog.0000000000002593.
BJOG: An International Journal of Obstetrics and GynaecologyJournal
Posterior Colporrhaphy: Its Effects on Bowel and Sexual Function
Kahn, Margie A., and Stuart L. Stanton. 1997. “Posterior Colporrhaphy: Its Effects on Bowel and Sexual Function”. BJOG: An International Journal of Obstetrics and Gynaecology. Wiley. doi:10.1111/j.1471-0528.1997.tb10654.x.
~21 spots leftby Apr 2025
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