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

NARecruitingINTERVENTIONAL
Enrollment

476

Participants

Timeline

Start Date

May 1, 2025

Primary Completion Date

April 30, 2029

Study Completion Date

April 30, 2029

Conditions
Stress Urinary IncontinenceVaginal Prolapse
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.

Trial Locations (1)

44106

RECRUITING

University Hospitals Cleveland Medical Center, Cleveland

All Listed Sponsors
collaborator

University of Pittsburgh Medical Center

OTHER

collaborator

Kaiser Permanente

OTHER

collaborator

Duke University

OTHER

collaborator

Patient-Centered Outcomes Research Institute

OTHER

collaborator

University of California, San Diego

OTHER

collaborator

University of California, Irvine

OTHER

collaborator

MetroHealth Medical Center

OTHER

collaborator

Ohio State University

OTHER

collaborator

Northwestern University

OTHER

collaborator

University of New Mexico

OTHER

collaborator

Medstar Health Research Institute

OTHER

lead

University Hospitals Cleveland Medical Center

OTHER