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
Parallel
RP-MUS
Devicea standard urethral sling placement for treatment of stress urinary incontinence
PAHG
Procedure/SurgeryA 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.
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.
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.
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
Number of retreatment for SUI as measured by medical record review/patient report
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).
Click on the lead sponsor to view all of their trials.
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
