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

NCT06754046 | Recruiting DMC FDA Device

• 1 other identifier: STUDY20241497
• Study Type: interventional
• Target: 476
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

midurethral sling; bulkamide; polyacrylamide hydrogel; urethral bulking; retropubic sling

Outcome Measures

Primary Outcomes (1)

• Bothersome stress urinary incontinence symptoms as measured by urogenital distress inventory long form (UDI)

  a questionnaire used to assess the severity of lower urinary tract symptoms like incontinence, particularly in women, by measuring the impact of these symptoms on their quality of life. Scores range from 0 to 100, higher number indicates worse symptoms.

  24 months postoperatively

Secondary Outcomes (7)

• Change in bothersome stress urinary incontinence symptoms as measured by urogenital distress inventory long form (UDI)

  1, 6 and 12 months postoperatively

• Change in patient assessment of improvement as measured by the Patient Global Impression of Improvement (PGI-I)

  1 month, 6 months, 12 months and 24 months postoperatively

• Number of retreatment for SUI as measured by medical record review/patient report

  up to 24 months post operatively

• Change in Lower urinary tract dysfunction research network symptom index-29 (LURN-SI-29)

  preoperatively, 1, 6, 12 and 24 months postoperatively

• Change in Female Sexual Function Inventory (FSFI)

  preoperatively, 1, 6, 12 and 24 months postoperatively

Study Arms (2)

Retropubic Midurethral Sling (RP-MUS)

ACTIVE COMPARATOR

A minimally invasive surgical procedure that treats stress urinary incontinence (SUI) in women by placing a small strip of tape passed through the retropubic space, with entry and exit points in the lower abdomen or groin.

Device: RP-MUS

Urethral Bulking with polyacrylamide hydrogel (PAHG)

ACTIVE COMPARATOR

PAHG will be performed using the standard 2 mL dose injection order and number will be at the discretion of the surgeon. 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.

Procedure: PAHG

Interventions

RP-MUS DEVICE

a standard urethral sling placement for treatment of stress urinary incontinence

Retropubic Midurethral Sling (RP-MUS)

PAHG PROCEDURE

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.

Urethral Bulking with polyacrylamide hydrogel (PAHG)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Gender assigned female at birth
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women ≥ 18 years of age.
• Have diagnosis of symptomatic or occult stress urinary incontinence (SUI) as noted in their electronic health record (EHR).
• Proof of positive testing for SUI via cough stress test (CST) and/or Urodynamic (UDS) testing,
• Patients that are planning and eligible for native tissue prolapse repair and for both Retropubic Midurethral Sling (RP-MUS) and Polyacrylamide Hydrogel (PAHG)

You may not qualify if:

• Patients undergoing pelvic organ prolapse repair using mesh or biologic augmentation other than patient's own tissue
• Patient anticipating difficulty with completing 24-month follow-up
• Anticipation of pregnancy within subsequent 24-months or \<18 months post-partum
• Hemoglobin A1c \>10.0% within the past 3-months
• Current smoker \> 1 pack per week
• History of neurogenic bladder
• Current use of any catheterization including but not limited to, intermittent catheterization, indwelling Foley catheter, or suprapubic catheter
• Post-void residual \>150 mL felt to not be due to obstruction for prolapse
• Prior history of any anti-incontinence procedure including but not limited to any synthetic sling, fascial sling, Burch colposuspension or its variants, and urethral bulking
• Previous history of any pelvic radiation
• Patient receiving a planned concurrent procedure at the time of prolapse repair.

Sponsors & Collaborators

• Patient-Centered Outcomes Research Institute: collaborator
• University of California, Irvine: collaborator
• MetroHealth Medical Center: collaborator
• Ohio State University: collaborator
• Northwestern University: collaborator
• University of New Mexico: collaborator
• University Hospitals Cleveland Medical Center: lead
• Kaiser Permanente: collaborator
• Duke University: collaborator
• University of California, San Diego: collaborator
• Medstar Health Research Institute: collaborator

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Urinary Incontinence, Stress; Uterine Prolapse

Condition Hierarchy (Ancestors)

Urinary Incontinence; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Uterine Diseases; Genital Diseases, Female; Genital Diseases; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Anatomical

Study Officials

• David Sheyn, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

• Cecile Ferrando, MD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elisar Khawam

CONTACT

216-844-2493; Elisar.Khawam@UHhospitals.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: December 23, 2024
• First Posted: December 31, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029
• Last Updated: May 6, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)