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NCT Number: NCT04480671

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

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.

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Key information

Conditions

Pelvic Organ Prolapse Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Prolapse

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)*

Treatment and study plan

Level III support procedure

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.

Minimally Invasive Sacrocolpopexy

Procedure

All study participants are planning with their surgeon a minimally invasive sacrocolpopexy (robotic or laparoscopic) to repair pelvic organ prolapse.

Transperineal ultrasound of the Pelvic Floor

Other

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.

Primary outcomes

  1. Enlarged Genital Hiatus at 6 months postoperatively

    Time frame: 6 months postoperatively

    Proportion of subjects with enlarged genital hiatus on pelvic exam

Secondary outcomes

  1. 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.

  2. Subjective prolapse recurrence

    Time frame: 24 months

    Any symptomatic recurrence of prolapse on questionnaire

  3. 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.

  4. 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.

  5. 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.

  6. Levator Hiatal Area

    Time frame: baseline, 6 months postoperatively

    Measurement of the levator hiatus on transperineal ultrasound

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

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

Acronym: MERIT

Important dates

Study start
2020
Primary completion
2023
Study completion
2024
First posted
Jul 21, 2020
Registry last updated
Oct 1, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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