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.
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)
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
University Hospitals Cleveland Medical Center
Lead sponsor
Kaiser Permanente
Collaborator
Duke University
Collaborator
Patient-Centered Outcomes Research Institute
Collaborator
University of California, San Diego
Collaborator
University of California, Irvine
Collaborator
MetroHealth Medical Center
Collaborator
Ohio State University
Collaborator
Northwestern University
Collaborator
University of New Mexico
Collaborator
Medstar Health Research Institute
Collaborator
University of Michigan
Collaborator