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

University of Pittsburgh94 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Pelvic Organ Prolapse

Interventions

Transperineal ultrasound of the Pelvic FloorOTHER

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)\*

Outcomes

Primary Outcomes

Enlarged Genital Hiatus at 6 months postoperatively

Proportion of subjects with enlarged genital hiatus on pelvic exam

Time frame: 6 months postoperatively

Secondary Outcomes

Composite prolapse recurrence

Any anatomic prolapse recurrence beyond the hymen, symptomatic on questionnaire, or retreatment for prolapse with surgery or pessary.

Time frame: 12 months

Subjective prolapse recurrence

Any symptomatic recurrence of prolapse on questionnaire

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: baseline, 6, 12 months postoperatively

Levator Hiatal Area

Measurement of the levator hiatus on transperineal ultrasound

Time frame: baseline, 6 months postoperatively