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

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.

Conditions

• Stress Urinary Incontinence
• Vaginal Prolapse

Interventions

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.

DEVICE

RP-MUS

a standard urethral sling placement for treatment of stress urinary incontinence

Sponsors & Collaborators

• Kaiser Permanente

  collaborator OTHER

• Duke University

  collaborator OTHER

• Patient-Centered Outcomes Research Institute

  collaborator OTHER

• University of California, San Diego

  collaborator OTHER

• University of California, Irvine

  collaborator OTHER

• MetroHealth Medical Center

  collaborator OTHER

• Ohio State University

  collaborator OTHER

• Northwestern University

  collaborator OTHER

• University of New Mexico

  collaborator OTHER

• Medstar Health Research Institute

  collaborator OTHER

• University Hospitals Cleveland Medical Center

  lead OTHER

Principal Investigators

• David Sheyn, MD · University Hospitals Cleveland Medical Center

• Cecile Ferrando, MD · University of California, San Diego

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-05-01

Primary Completion

2029-04-30

Completion

2029-04-30

FDA Device

Yes

Countries

• United States

Study Locations