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

Pelvic Organ Prolapse Clinical Trial

— MERIT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04480671
• Other study ID #: STUDY19110286
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 26, 2020
• Est. completion date: August 1, 2024

Study information

• Verified date: July 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 94
• Est. completion date: August 1, 2024
• Est. primary completion date: February 2, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)*

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Procedure:
• Level III support 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.
• Minimally Invasive Sacrocolpopexy
All study participants are planning with their surgeon a minimally invasive sacrocolpopexy (robotic or laparoscopic) to repair pelvic organ prolapse.

Other:
• Transperineal ultrasound of the Pelvic Floor
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.

Locations

Country	Name	City	State
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

Kahn MA, Stanton SL. Posterior colporrhaphy: its effects on bowel and sexual function. Br J Obstet Gynaecol. 1997 Jan;104(1):82-6. doi: 10.1111/j.1471-0528.1997.tb10654.x. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enlarged Genital Hiatus at 6 months postoperatively	Proportion of subjects with enlarged genital hiatus on pelvic exam	6 months postoperatively
Secondary	Composite prolapse recurrence	Any anatomic prolapse recurrence beyond the hymen, symptomatic on questionnaire, or retreatment for prolapse with surgery or pessary.	12 months
Secondary	Subjective prolapse recurrence	Any symptomatic recurrence of prolapse on questionnaire	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Levator Hiatal Area	Measurement of the levator hiatus on transperineal ultrasound	baseline, 6 months postoperatively