Clinical trial NCT06754046: BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair (BELIEVE)
Official title: BELIEVE Trial: Bulking vErsus sLing for Treating Stress Urinary IncontinEnce at the Time of Vaginal prolapsE Repair
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stress Urinary Incontinence
Vaginal Prolapse
Keywords: midurethral sling
bulkamide
polyacrylamide hydrogel
urethral bulking
retropubic sling
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh Medical Center
name: Kaiser Permanente
name: Duke University
name: Patient-Centered Outcomes Research Institute
name: University of California, San Diego
name: University of California, Irvine
name: MetroHealth Medical Center
name: Ohio State University
name: Northwestern University
name: University of New Mexico
name: Medstar Health Research Institute
First posted: 2024-12-31
Enrollment: 476
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: Inclusion 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)

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.

Primary outcomes:
measure: Bothersome stress urinary incontinence symptoms as measured by urogenital distress inventory long form (UDI)
timeFrame: 24 months postoperatively
Secondary outcomes:
measure: Change in bothersome stress urinary incontinence symptoms as measured by urogenital distress inventory long form (UDI)
timeFrame: 1, 6 and 12 months postoperatively
measure: Change in patient assessment of improvement as measured by the Patient Global Impression of Improvement (PGI-I)
timeFrame: 1 month, 6 months, 12 months and 24 months postoperatively
measure: Number of retreatment for SUI as measured by medical record review/patient report
timeFrame: up to 24 months post operatively
measure: Change in Lower urinary tract dysfunction research network symptom index-29 (LURN-SI-29)
timeFrame: preoperatively, 1, 6, 12 and 24 months postoperatively
measure: Change in Female Sexual Function Inventory (FSFI)
timeFrame: preoperatively, 1, 6, 12 and 24 months postoperatively
measure: Average of Perioperative morbidity
timeFrame: Up 24 months postoperatively
measure: Pelvic organ prolapse recurrence (POP-Q)
timeFrame: preoperatively, 1, 6, 12 and 24 months postoperatively
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: David Sheyn, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Diego
name: Cecile Ferrando, MD
role: PRINCIPAL_INVESTIGATOR
References: