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

NCT ID: NCT06754046

Last Updated: 2025-05-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 476 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2029-04-30

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.

Detailed Description

This will be a double-blinded, non-inferiority, controlled trial utilizing a 1:1 randomization scheme to assign patients to each treatment arm (PAHG vs. RP-MUS). Patients undergoing PAHG will be given sham incisions in order to mask the type of SUI procedure they underwent. This will consist of two "earring-hole" sized superficial scratches in the epidermis and fibrin glue applied to the expected suprapubic exit sites for the RP-MUS. Sham incisions are not associated with an increased risk of infection and are considered low risk. Validated symptom questionnaires will be administered to the patient by a study investigator prior to surgery and at 1, 6, 12, and 24 months. At the final study visit, patients will be un-blinded and provided information on which SUI procedure they underwent. Unless it is necessary for subsequent care, as in the case of a procedure specific complication like a mesh erosion, patients who might require additional intervention for recurrent SUI during the study period will remain blinded to their initial treatment assignment. If patients request this information, they will be informed that they would need to exit the study, however their data would still be analyzed as part of the intention to treat protocol. Data of patients who dropout will be analyzed in the same manner. Pelvic organ prolapse procedures will be limited to native tissue repairs only and may include either or both apical and non-apical repair procedures; selection of appropriate POP repair procedure will be at the surgeon's discretion. All randomized patients will complete surveys at 12 and 24 months will assess patient recovery, satisfaction with care, and calibrating surveyed and clinically assessed outcomes to their daily life experiences. Based on prior similar studies, this number is sufficient to ensure saturation of themes83. Between 8 to 20 participants in each arm will be randomly selected from across all sites to participate in individual semi-structured telephone interviews preoperatively, at 12 months and at 24 months after surgery.

Conditions

Stress Urinary Incontinence; Vaginal Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Retropubic Midurethral Sling (RP-MUS)

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.

Group Type: ACTIVE_COMPARATOR

RP-MUS

Intervention Type: DEVICE

a standard urethral sling placement for treatment of stress urinary incontinence

Urethral Bulking with polyacrylamide hydrogel (PAHG)

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.

Group Type: ACTIVE_COMPARATOR

PAHG

Intervention Type: 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.

Interventions

RP-MUS

a standard urethral sling placement for treatment of stress urinary incontinence

Intervention Type: DEVICE

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Women ≥ 18 years of age.
• Have diagnosis of symptomatic 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 vaginal prolapse repair and for both Retropubic Midurethral Sling (RP-MUS) and Polyacrylamide Hydrogel (PAHG)

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Pittsburgh Medical Center

OTHER

Sponsor Role: collaborator

Kaiser Permanente

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: collaborator

Patient-Centered Outcomes Research Institute

OTHER

Sponsor Role: collaborator

University of California, San Diego

OTHER

Sponsor Role: collaborator

University of California, Irvine

OTHER

Sponsor Role: collaborator

MetroHealth Medical Center

OTHER

Sponsor Role: collaborator

Ohio State University

OTHER

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: collaborator

University of New Mexico

OTHER

Sponsor Role: collaborator

Medstar Health Research Institute

OTHER

Sponsor Role: collaborator

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

David Sheyn

Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Sheyn, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Cecile Ferrando, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Elisar Khawam

Role: CONTACT

Elisar.Khawam@UHhospitals.org

216-844-2493

Facility Contacts

Elisar Khawam

Role: primary

Elisar.Khawam@UHhospitals.org

216-844-2493

Other Identifiers

STUDY20241497

Identifier Type: -

Identifier Source: org_study_id