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

Not Applicable

Completed

• Conditions: Pelvic Organ Prolapse
• Interventions: Procedure: Level III support procedure; Procedure: Minimally Invasive Sacrocolpopexy; Other: Transperineal ultrasound of the Pelvic Floor

• Registration Number: NCT04480671
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2020-07-16
• Study First Posted: 2020-07-21
• Study Start: 2020-08-26
• Primary Completion: 2023-02-02
• Study Completion: 2024-07-25
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-27
• Last Update Posted: 2024-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 94

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sacrocolpopexy and concomitant level III support procedure	Minimally Invasive Sacrocolpopexy	This randomized group will receive an additional vaginal repair for level III support at the conclusion of the sacrocolpopexy.
Sacrocolpopexy and concomitant level III support procedure	Transperineal ultrasound of the Pelvic Floor	This randomized group will receive an additional vaginal repair for level III support at the conclusion of the sacrocolpopexy.
Sacrocolpopexy	Minimally Invasive Sacrocolpopexy	This group will only receive the sacrocolpopexy for their pelvic organ prolapse repair.
Sacrocolpopexy	Transperineal ultrasound of the Pelvic Floor	This group will only receive the sacrocolpopexy for their pelvic organ prolapse repair.
Sacrocolpopexy and concomitant level III support procedure	Level III support procedure	This randomized group will receive an additional vaginal repair for level III support at the conclusion of the sacrocolpopexy.

Primary Outcome Measures

Name	Time	Method
Enlarged Genital Hiatus at 6 months postoperatively	6 months postoperatively	Proportion of subjects with enlarged genital hiatus on pelvic exam

Secondary Outcome Measures

Name	Time	Method
Composite prolapse recurrence	12 months	Any anatomic prolapse recurrence beyond the hymen, symptomatic on questionnaire, or retreatment for prolapse with surgery or pessary.
Subjective prolapse recurrence	24 months	Any symptomatic recurrence of prolapse on questionnaire
Sexual Function postoperatively	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.
Pelvic Floor Distress Inventory Change	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.
Levator Hiatal Area	baseline, 6 months postoperatively	Measurement of the levator hiatus on transperineal ultrasound
Dyspareunia postoperatively	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.

Trial Locations

Locations (1)

University of Pittsburgh Medical Center; 🇺🇸 Pittsburgh, Pennsylvania, United States