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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Stress Urinary Incontinence; Vaginal Prolapse
• Intervention / Treatment: Procedure: PAHG; Device: RP-MUS

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.

• Study Type: Interventional
• Enrollment (Estimated): 476
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Elisar Khawam; Phone Number: 216-844-2493; Email: Elisar.Khawam@UHhospitals.org

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44106
      • Recruiting
      • University Hospitals Cleveland Medical Center
      • Contact: Elisar Khawam; Phone Number: 216-844-2493; Email: Elisar.Khawam@UHhospitals.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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)

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Device: RP-MUS; a standard urethral sling placement for treatment of stress urinary incontinence
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in 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.	1, 6 and 12 months postoperatively
Change in patient assessment of improvement as measured by the Patient Global Impression of Improvement (PGI-I)	Patient Global Impression of Improvement (PGI-I) score is a rating on a scale from 1 to 7 that measures a patient's perception of how their condition has changed in response to treatment	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)	A patient-centric questionnaire developed to provide a comprehensive assessment of lower urinary tract symptoms including symptoms of overactive bladder and voiding dysfunction. Scoring ranges from 0 (least severe) to 100 (most severe).	preoperatively, 1, 6, 12 and 24 months postoperatively
Change in Female Sexual Function Inventory (FSFI)	This 19 item questionnaire will assess sexual function and body image. It has a scoring range from 2 to 36 with higher scores indicating better sexual functioning.	preoperatively, 1, 6, 12 and 24 months postoperatively
Average of Perioperative morbidity	Perioperative morbidity will be assessed using the Clavien-Dindo classification. The classification is a system for grading the severity of postoperative complications based on the level of intervention required to treat them. The CD classification uses five grades of severity, with Grade I being low and Grade V being death.	Up 24 months postoperatively
Pelvic organ prolapse recurrence (POP-Q)	Recurrence of pelvic organ prolapse is assessed utilizing the POP-Q system classifies pelvic organ prolapse into four stages. It ranges from Stage I (most distal part of the prolapse is more than 1 cm above the hymen) to Stage IV (Complete procidentia or vault eversion)	preoperatively, 1, 6, 12 and 24 months postoperatively

Collaborators and Investigators

• Sponsor: University Hospitals Cleveland Medical Center
• Collaborators: Patient-Centered Outcomes Research Institute; University of California, San Diego; Northwestern University; University of Michigan; Duke University; Ohio State University; University of California, Irvine; Kaiser Permanente; Medstar Health Research Institute; University of New Mexico; MetroHealth Medical Center
• Investigators: Principal Investigator: David Sheyn, MD, University Hospitals Cleveland Medical Center; Principal Investigator: Cecile Ferrando, MD, University of California, San Diego

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2025
• Primary Completion (Estimated): April 1, 2029
• Study Completion (Estimated): April 1, 2029

Study Registration Dates

• First Submitted: December 23, 2024
• First Submitted That Met QC Criteria: December 23, 2024
• First Posted (Actual): December 31, 2024

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: midurethral sling; polyacrylamide hydrogel; retropubic sling; bulkamide; urethral bulking
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Male Urogenital Diseases; Pathological Conditions, Anatomical; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Uterine Diseases; Genital Diseases, Female; Urinary Incontinence; Pelvic Organ Prolapse; Prolapse; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Urinary Incontinence, Stress; Uterine Prolapse
• Other Study ID Numbers: STUDY20241497

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD will not be shared with other researchers to ensure participant privacy is maintained and avoid any risk of invalid analyses.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No