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

Study Overview
=================
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.

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

Conditions
-----------------
Pelvic Organ Prolapse

Intervention / Treatment
-----------------
* Procedure: Level III support procedure
* Procedure: Minimally Invasive Sacrocolpopexy
* Other: Transperineal ultrasound of the Pelvic Floor


Participation Criteria
=================
Eligibility Criteria
-----------------
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)*

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sacrocolpopexy<br>This group will only receive the sacrocolpopexy for their pelvic organ prolapse repair. | Procedure: Minimally Invasive Sacrocolpopexy<br>* All study participants are planning with their surgeon a minimally invasive sacrocolpopexy (robotic or laparoscopic) to repair pelvic organ prolapse.<br>Other: Transperineal ultrasound of the Pelvic Floor<br>* 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.<br>|
| Active Comparator: Sacrocolpopexy and concomitant level III support procedure<br>This randomized group will receive an additional vaginal repair for level III support at the conclusion of the sacrocolpopexy. | Procedure: Level III support procedure<br>* A level III support procedure is aimed at repairing the distal support of the vagina with either a posterior colporrhaphy and/or a perineorrhaphy.<br>Procedure: Minimally Invasive Sacrocolpopexy<br>* All study participants are planning with their surgeon a minimally invasive sacrocolpopexy (robotic or laparoscopic) to repair pelvic organ prolapse.<br>Other: Transperineal ultrasound of the Pelvic Floor<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Enlarged Genital Hiatus at 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 | Any anatomic prolapse recurrence beyond the hymen, symptomatic on questionnaire, or retreatment for prolapse with surgery or pessary. | 12 months | 
| Subjective prolapse recurrence | Any symptomatic recurrence of prolapse on questionnaire | 24 months | 
| Dyspareunia 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 | 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 | 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 | Measurement of the levator hiatus on transperineal ultrasound | baseline, 6 months postoperatively |