Recruiting

Bulking & Sling

Sponsor:

University Hospitals Cleveland Medical Center

Code:

NCT06754046

Conditions

Stress Urinary Incontinence

Vaginal Prolapse

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

RP-MUS

PAHG

Study Details

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.

Conditions

Stress Urinary Incontinence

Vaginal Prolapse

Study ID

NCT06754046

Start date

May 1, 2025

Status verified date

May, 2026

Completion date

Apr, 2029

Anticipated

Primary completion date

Apr, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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)

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.

Study Design

Enrollment

476 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Retropubic Midurethral Sling (RP-MUS)

A minimally invasive surgical procedure that treats stress urinary incontinence (SUI) in women by placing a small strip of tape passed through the retropubic space, with entry and exit points in the lower abdomen or groin.

active comparator: Urethral Bulking with polyacrylamide hydrogel (PAHG)

PAHG will be performed using the standard 2 mL dose injection order and number will be at the discretion of the surgeon. 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.

Interventions

RP-MUS

a standard urethral sling placement for treatment of stress urinary incontinence

PAHG

A 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.

Primary outcome measure

  • Bothersome stress urinary incontinence symptoms as measured by urogenital distress inventory long form (UDI) [ Time Frame: 24 months postoperatively ]

Central Contacts and Locations

Central contacts

Elisar Khawam

216-844-2493Elisar.Khawam@UHhospitals.org

Locations

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Contacts

Elisar Khawam

216-844-2493Elisar.Khawam@UHhospitals.org

More Information

Sponsor

University Hospitals Cleveland Medical Center

Last update posted

Jun 1, 2026

Last verified

May, 2026

Keywords

  • midurethral sling
  • bulkamide
  • polyacrylamide hydrogel
  • urethral bulking
  • retropubic sling

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University Hospitals Cleveland Medical Center on 2026-06-01.