Impact of Level III Support Procedure on Enlarged Genital Hiatus After Minimally Invasive Sacrocolpopexy (MERIT)

July 31, 2023 updated by: Stephanie Glass Clark, University of Pittsburgh

Impact of Level III Support Procedure on Normalization of Enlarged Genital Hiatus After Minimally Invasive Sacrocolpopexy: a Randomized Controlled Trial

This is a randomized controlled surgical trial evaluating the use of a concomitant posterior colporrhaphy and/or perineorrhaphy at the conclusion of minimally invasive sacrocolpopexy to narrow enlarged genital hiatuses in a population of women with pelvic organ prolapse. The study's primary outcome is the proportion of women at 6 months postoperatively who still have an enlarged genital hiatus.

An exploratory sub-aim (as of October 2021) of the study is to evaluate the levator hiatal area as compared with the genital hiatus by using preoperative and postoperative transperineal ultrasounds. Subjects will be invited to participate, but is not required for study participation.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Female subjects with pelvic organ prolapse (POP)
  • Planning a surgical repair of POP with minimally invasive sacrocolpopexy
  • Preoperative resting genital hiatus measure between 4.0 and 7.5cm

Exclusion Criteria: subjects who are unable to complete questionnaires or repeat office exams or if they do not otherwise meet inclusion criteria above

*Note: we will NOT exclude patients based on prior surgical history (including prior posterior colporrhaphy)*

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Sacrocolpopexy
This group will only receive the sacrocolpopexy for their pelvic organ prolapse repair.
Procedure: Minimally Invasive Sacrocolpopexy
All study participants are planning with their surgeon a minimally invasive sacrocolpopexy (robotic or laparoscopic) to repair pelvic organ prolapse.
Other: Transperineal ultrasound of the Pelvic Floor
Subjects from either arm will be invited to participate in this exploratory arm of the study. If they choose to participate, they will have a preoperative ultrasound performed and an ultrasound performed at the time of their 6 month visit.
Active Comparator: Sacrocolpopexy and concomitant level III support procedure
This randomized group will receive an additional vaginal repair for level III support at the conclusion of the sacrocolpopexy.
Procedure: Minimally Invasive Sacrocolpopexy
All study participants are planning with their surgeon a minimally invasive sacrocolpopexy (robotic or laparoscopic) to repair pelvic organ prolapse.
Other: Transperineal ultrasound of the Pelvic Floor
Subjects from either arm will be invited to participate in this exploratory arm of the study. If they choose to participate, they will have a preoperative ultrasound performed and an ultrasound performed at the time of their 6 month visit.
Procedure: Level III support procedure
A level III support procedure is aimed at repairing the distal support of the vagina with either a posterior colporrhaphy and/or a perineorrhaphy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enlarged Genital Hiatus at 6 months postoperatively
Time Frame: 6 months postoperatively
Proportion of subjects with enlarged genital hiatus on pelvic exam
6 months postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite prolapse recurrence
Time Frame: 12 months
Any anatomic prolapse recurrence beyond the hymen, symptomatic on questionnaire, or retreatment for prolapse with surgery or pessary.
12 months
Subjective prolapse recurrence
Time Frame: 24 months
Any symptomatic recurrence of prolapse on questionnaire
24 months
Dyspareunia postoperatively
Time Frame: 6, 12 months postoperatively
Incidence of pain with sex (dyspareunia), ascertained with the use of a validated questionnaire for sexual function [the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)].This questionnaire indicates worse pain with sex with higher score.
6, 12 months postoperatively
Sexual Function postoperatively
Time Frame: 6, 12 months postoperatively
Assessment of sexual function, ascertained with the use of a validated questionnaire for sexual function [the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR)]. This questionnaire helps us determine what impact pelvic organ prolapse has on sexual activity.
6, 12 months postoperatively
Pelvic Floor Distress Inventory Change
Time Frame: baseline, 6, 12 months postoperatively
Measurement of pelvic floor distress change, using the Pelvic Floor Distress Inventory questionnaire (PFDI-20) which is a validated questionnaire used for pelvic floor disorders and their impact on patient quality of life.
baseline, 6, 12 months postoperatively
Levator Hiatal Area
Time Frame: baseline, 6 months postoperatively
Measurement of the levator hiatus on transperineal ultrasound
baseline, 6 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Pittsburgh

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 26, 2020

Primary Completion (Actual)

February 2, 2023

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

December 17, 2019

First Submitted That Met QC Criteria

July 16, 2020

First Posted (Actual)

July 21, 2020

Study Record Updates

Last Update Posted (Actual)

August 1, 2023

Last Update Submitted That Met QC Criteria

July 31, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY19110286

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

There is no plan to make IPD available to other researchers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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