RP-MUS vs PAHG for Stress Incontinence

(BELIEVE Trial)

Overseen By Elisar Khawam

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University Hospitals Cleveland Medical Center

Disqualifiers: Pregnancy, Neurogenic bladder, Catheter use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 24 months

476 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment PAHG, RP-MUS for stress incontinence?

The research shows that mid-urethral slings (MUS) are widely used and considered effective for treating stress urinary incontinence in women, suggesting that RP-MUS could be beneficial. However, some women experience recurrent incontinence after MUS, indicating that while effective for many, it may not work for everyone. ^{1 2 3 4 5}

Is the RP-MUS treatment generally safe for humans?

The RP-MUS (retropubic midurethral sling) procedure for stress urinary incontinence has been widely used and generally has low complication rates, although there have been some long-term safety concerns and re-procedures due to complications. ^{4 6 7 8 9}

What is the purpose of this trial?

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.

Research Team

David Sheyn, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Cecile Ferrando, MD

Principal Investigator

University of California, San Diego

Eligibility Criteria

The BELIEVE trial is for women over 18 with stress urinary incontinence confirmed by tests, who are also getting vaginal prolapse repair. It's not specified who can't join because the exclusion criteria are missing.

Inclusion Criteria

I am a woman aged 18 or older.

I have been diagnosed with stress urinary incontinence.

I have tested positive for stress urinary incontinence.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either retropubic midurethral sling (RP-MUS) or urethral bulking with polyacrylamide hydrogel (PAHG) during pelvic organ prolapse repair

24 months

6 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with assessments at 1, 6, 12, and 24 months

24 months

4 visits (in-person)

Qualitative Interviews

Selected participants complete qualitative interviews at 3 timepoints over the 24-month duration

24 months

Treatment Details

Interventions

• PAHG
• RP-MUS

Trial Overview This study compares two treatments during prolapse repair surgery: a sling procedure (RP-MUS) and an injection (PAHG). Women will be randomly assigned to one treatment without knowing which they received, followed up for 24 months.

Participant Groups

Group I: Retropubic Midurethral Sling (RP-MUS) Active Control 1 Intervention

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.

Group II: Urethral Bulking with polyacrylamide hydrogel (PAHG) Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials

348

Recruited

394,000+

University of California, San Diego

Collaborator

Trials

1,215

Recruited

1,593,000+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Medstar Health Research Institute

Collaborator

Trials

202

Recruited

187,000+

University of California Irvine (UCI)

Collaborator

Trials

2

Recruited

2,100+

MetroHealth Medical Center

Collaborator

Trials

125

Recruited

22,600+

Ohio State University Wexner Medical Center

Collaborator

Trials

3

Recruited

620+

Northwestern University

Collaborator

Trials

1,674

Recruited

989,000+

University of Pittsburgh Medical Center

Collaborator

Trials

78

Recruited

77,600+

References

1. England pubmed.ncbi.nlm.nih.gov

Recurrent stress urinary incontinence after synthetic mid-urethral sling procedures. [2011]

2. England pubmed.ncbi.nlm.nih.gov

Risk factors of treatment failure of midurethral sling procedures for women with urinary stress incontinence. [2022]

3. Italy pubmed.ncbi.nlm.nih.gov

Comparison of TVT, TVT-O/TOT and mini slings for the treatment of female stress urinary incontinence: 30 months follow up in 531 patients. [2016]

4. England pubmed.ncbi.nlm.nih.gov

Long-term efficacy and safety of tension free vaginal tape in a historic cohort of 463 women with stress urinary incontinence. [2019]

5. Pakistan pubmed.ncbi.nlm.nih.gov

The practice of Burch Colposuspension versus Mid Urethral Slings for the treatment of Stress Urinary Incontinence in developing country. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Medium-term and long-term outcomes following placement of midurethral slings for stress urinary incontinence: a systematic review and metaanalysis. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Long-term re-procedure rate after mid-urethral slings for stress urinary incontinence. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Contemporary trends for urological training and management of stress urinary incontinence in Ireland. [2022]

9. Korea (South) pubmed.ncbi.nlm.nih.gov

The evolution of surgical treatment for female stress urinary incontinence: era of mid-urethral slings. [2021]