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RECRUITING
NCT06754046
NA

BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)

Sponsor: University Hospitals Cleveland Medical Center

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to learn if retropubic midurethral sling (RP-MUS) or bulkamide injection (PAHG) at the time of pelvic organ prolapse repair is better from the patient's perspective. The main questions it aims to answer are: What is the average difference in the urogenital distress inventory (UDI) long form score 24 months after surgery for each procedure? Which procedure has the fewest complications and lowest short- and long-term morbidity profile? Participants will: Be blinded and randomized to one of two procedures for the duration of the study, 24 months. Complete 6 total visits for the clinical trial including validated questionnaires. Few participants will be selected to complete a qualitative interview at 3 timepoints over 24 month duration of the study.

Official title: BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

476

Start Date

2025-05-01

Completion Date

2029-04

Last Updated

2025-05-06

Healthy Volunteers

No

Interventions

DEVICE

RP-MUS

a standard urethral sling placement for treatment of stress urinary incontinence

PROCEDURE

PAHG

A standard 2 mL dose injection of bulkamid (order and number will be at the discretion of the surgeon) will be given. Patients undergoing PAHG will be given sham incisions consisting of superficial suprapubic epidermal scratches with a needle and fibrin glue at expected sling exit sites.

Locations (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States