RECRUITING

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

Conditions

Stress Urinary Incontinence Vaginal Prolapse midurethral sling bulkamide polyacrylamide hydrogel urethral bulking retropubic sling

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-01

Study Completion:2029-04

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06754046

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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)	* 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.

Inclusion Criteria

Exclusion 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)

* 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.

Contacts and Locations

Study Contact

Elisar Khawam

CONTACT

216-844-2493

Elisar.Khawam@UHhospitals.org

Principal Investigator

David Sheyn, MD

PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Cecile Ferrando, MD

PRINCIPAL_INVESTIGATOR

University of California, San Diego

Study Locations (Sites)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106

United States

Collaborators and Investigators

Sponsor: University Hospitals Cleveland Medical Center

David Sheyn, MD, PRINCIPAL_INVESTIGATOR, University Hospitals Cleveland Medical Center
Cecile Ferrando, MD, PRINCIPAL_INVESTIGATOR, University of California, San Diego

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-01

Study Completion Date2029-04

Study Record Updates

Study Start Date2025-05-01

Study Completion Date2029-04

Terms related to this study

Keywords Provided by Researchers

midurethral sling
bulkamide
polyacrylamide hydrogel
urethral bulking
retropubic sling

Additional Relevant MeSH Terms

Stress Urinary Incontinence
Vaginal Prolapse