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

NCT04480671 | Completed

• 1 other identifier: STUDY19110286
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

Pelvic Organ Prolapse

Outcome Measures

Primary Outcomes (1)

• Enlarged Genital Hiatus at 6 months postoperatively

  Proportion of subjects with enlarged genital hiatus on pelvic exam

  6 months postoperatively

Secondary Outcomes (6)

• Composite prolapse recurrence

  12 months

• Subjective prolapse recurrence

  24 months

• Dyspareunia postoperatively

  6, 12 months postoperatively

• Sexual Function postoperatively

  6, 12 months postoperatively

• Pelvic Floor Distress Inventory Change

  baseline, 6, 12 months postoperatively

Study Arms (2)

Sacrocolpopexy

OTHER

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

Procedure: Minimally Invasive Sacrocolpopexy; Other: Transperineal ultrasound of the Pelvic Floor

Sacrocolpopexy and concomitant level III support procedure

ACTIVE COMPARATOR

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

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

Interventions

Level III support procedure 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.

Sacrocolpopexy and concomitant level III support procedure

Minimally Invasive Sacrocolpopexy PROCEDURE

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

Sacrocolpopexy; Sacrocolpopexy and concomitant level III support procedure

Transperineal ultrasound of the Pelvic Floor 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; Sacrocolpopexy and concomitant level III support procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (6)

• Bradley MS, Askew AL, Vaughan MH, Kawasaki A, Visco AG. Robotic-assisted sacrocolpopexy: early postoperative outcomes after surgical reduction of enlarged genital hiatus. Am J Obstet Gynecol. 2018 May;218(5):514.e1-514.e8. doi: 10.1016/j.ajog.2018.01.046. Epub 2018 Feb 6.

  PMID: 29425837 BACKGROUND

• Nosti PA, Umoh Andy U, Kane S, White DE, Harvie HS, Lowenstein L, Gutman RE. Outcomes of abdominal and minimally invasive sacrocolpopexy: a retrospective cohort study. Female Pelvic Med Reconstr Surg. 2014 Jan-Feb;20(1):33-7. doi: 10.1097/SPV.0000000000000036.

  PMID: 24368486 BACKGROUND

• Siddiqui NY, Geller EJ, Visco AG. Symptomatic and anatomic 1-year outcomes after robotic and abdominal sacrocolpopexy. Am J Obstet Gynecol. 2012 May;206(5):435.e1-5. doi: 10.1016/j.ajog.2012.01.035. Epub 2012 Feb 1.

  PMID: 22397900 BACKGROUND

• Vaughan MH, Siddiqui NY, Newcomb LK, Weidner AC, Kawasaki A, Visco AG, Bradley MS. Surgical Alteration of Genital Hiatus Size and Anatomic Failure After Vaginal Vault Suspension. Obstet Gynecol. 2018 Jun;131(6):1137-1144. doi: 10.1097/AOG.0000000000002593.

  PMID: 29742664 BACKGROUND

• Carter-Brooks CM, Lowder JL, Du AL, Lavelle ES, Giugale LE, Shepherd JP. Restoring Genital Hiatus to Normative Values After Apical Suspension Alone Versus With Level 3 Support Procedures. Female Pelvic Med Reconstr Surg. 2019 May/Jun;25(3):226-230. doi: 10.1097/SPV.0000000000000528.

  PMID: 29210807 BACKGROUND

• Sutkin G, Zyczynski HM, Sridhar A, Jelovsek JE, Rardin CR, Mazloomdoost D, Rahn DD, Nguyen JN, Andy UU, Meyer I, Gantz MG; NICHD Pelvic Floor Disorders Network. Association between adjuvant posterior repair and success of native tissue apical suspension. Am J Obstet Gynecol. 2020 Feb;222(2):161.e1-161.e8. doi: 10.1016/j.ajog.2019.08.024. Epub 2019 Aug 23.

  PMID: 31449806 BACKGROUND

MeSH Terms

Conditions

Pelvic Organ Prolapse

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Postoperative pelvic exams measuring anatomic recurrence of pelvic organ prolapse will be performed by a qualified examiner masked to the original surgery randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Urogynecology and Reconstructive Pelvic Surgery, Department of Obstetrics, Gynecology and Reproductive Sciences

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: July 21, 2020
• Study Start: August 26, 2020
• Primary Completion: February 2, 2023
• Study Completion: July 25, 2024
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)