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BELIEVE: Bulking versus Sling for Treating Stress Urinary Incontinence at the time of Vaginal Prolapse Repair

  • Sex: Female
  • Age: Adult (18 - 64), Older Adult (65+)
  • Accepting Healthy People: No
  • Type: Interventional / Therapeutic
  • Trial Phase: NA
  • Conditions Being Studied: Urinary Incontinence

Study Purpose

The purpose of this study is to compare the two most common corrective surgeries in the U.S. for stress urinary incontinence (SUI). No high-quality data exists to help guide patients and surgeons on the best option for treatment of SUI. The goal of the study is to determine which procedure works best from a patient’s perspective and has the lowest number of short-term and long-term medical problems. We will track the outcomes for each type of procedure and explore what is most important to women when deciding on a treatment option. The procedures are retropubic mid- urethral sling (RPMUS) or Bulkamid Polyacrylamide hydrogel (PAHG) injection.

Who Can Participate

Patients planning on having a surgery to correct pelvic organ prolapse (POP). These patients are also experiencing stress urinary incontinence (SUI) symptoms and are eligible for both procedures in the study, retropubic mid- urethral sling (RPMUS) or Bulkamid Polyacrylamide hydrogel (PAHG) injection, to treat these symptoms.

Principal Investigator
David Sheyn MD
Department/Division
Urology (Female Pelvic Medicine and Reconstructive Surgery)

Locations

UH Beachwood Medical Center
25501 Chagrin Blvd
Beachwood OH, 44122

UH Geauga Medical Center
13207 Ravenna Rd
Chardon OH, 44024

UH Parma Medical Center
7007 Powers Blvd
Parma OH, 44129

UH Portage Medical Center
6847 N Chestnut St
Ravenna Ohio, 44266

UH St. John Medical Center
29000 Center Ridge Rd
Westlake OH, 44145

UH St. John Health Center
26908 Detroit Rd
Westlake OH, 44145

  • UH IRB: STUDY20241497
  • StudyID: 2024-01634
  • ClinicalTrials.gov: NCT06754046
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