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

University of Pittsburgh

Status: Completed

Conditions: Pelvic Organ Prolapse

Treatments: Other: Transperineal ultrasound of the Pelvic Floor; Procedure: Minimally Invasive Sacrocolpopexy; Procedure: Level III support procedure

Study type: Interventional

Funder types: Other

Identifiers

NCT04480671

STUDY19110286

Details and patient eligibility

About

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.

Enrollment: 94 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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)*

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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94 participants in 2 patient groups

Sacrocolpopexy

Other group

Description:

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

Treatment:

Procedure: Minimally Invasive Sacrocolpopexy

Other: Transperineal ultrasound of the Pelvic Floor

Sacrocolpopexy and concomitant level III support procedure

Active Comparator group

Description:

This randomized group will receive an additional vaginal repair for level III support at the conclusion of the sacrocolpopexy.

Treatment:

Procedure: Level III support procedure

Procedure: Minimally Invasive Sacrocolpopexy

Other: Transperineal ultrasound of the Pelvic Floor