RECRUITING

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

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.

Conditions

Stress Urinary IncontinenceVaginal Prolapse
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Related Conditions:

Stress Urinary IncontinenceVaginal Prolapse

Study Overview

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Study Details

Study overview

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.

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

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

Condition
Stress Urinary Incontinence
Intervention / Treatment

-

Contacts and Locations

Cleveland

University Hospitals Cleveland Medical Center, Cleveland, Ohio, United States, 44106

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

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

2029-04