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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-26

Study Completion Date

2024-07-25

Brief Summary

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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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Detailed Description

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Conditions

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Pelvic Organ Prolapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Postoperative pelvic exams measuring anatomic recurrence of pelvic organ prolapse will be performed by a qualified examiner masked to the original surgery randomization.

Study Groups

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Sacrocolpopexy

This group will only receive the sacrocolpopexy for their pelvic organ prolapse repair.

Group Type OTHER

Minimally Invasive Sacrocolpopexy

Intervention Type 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

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Level III support procedure

Intervention Type 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

Intervention Type 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

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Minimally Invasive Sacrocolpopexy

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

Intervention Type PROCEDURE

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.

Intervention Type OTHER

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No