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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two treatments for stress urinary incontinence (SUI), a condition causing urine leakage during coughing, sneezing, or exercise. The trial aims to determine whether the retropubic midurethral sling (RP-MUS), a surgical tape supporting the urethra, or a polyacrylamide hydrogel (PAHG) injection, which adds bulk to the urethra, is more effective in reducing symptoms and complications. Women diagnosed with SUI who plan to undergo vaginal prolapse repair might be suitable candidates for this study. Participants will be randomly assigned to one of the treatments and will complete several visits and questionnaires over 24 months. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance future treatment options for SUI.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found the retropubic midurethral sling (RP-MUS) procedure both safe and effective for treating stress urinary incontinence in women. Research confirms its safety in both the short and long term. Although often considered a "gold-standard" treatment, RP-MUS can sometimes lead to complications like bladder injury or bleeding, though these are uncommon.

For urethral bulking with polyacrylamide hydrogel (PAHG), studies have shown it to be a safe and minimally invasive option. Patients generally tolerate it well, and long-term research supports its safety. This treatment involves injecting a gel to support the urethra, and it usually has a low rate of complications.

Both treatments have strong safety records, providing participants confidence in their safety based on existing research. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for stress urinary incontinence (SUI), like pelvic floor exercises and traditional sling surgeries, aim to support the urethra or strengthen the pelvic muscles. However, the Retropubic Midurethral Sling (RP-MUS) offers a minimally invasive surgical approach by placing a small strip of tape through the retropubic space, potentially making recovery quicker and less painful. On the other hand, Urethral Bulking with polyacrylamide hydrogel (PAHG) uses a unique method of injecting a gel to bulk up the urethral area, which can improve continence without major surgery. Researchers are excited about these treatments because they provide promising alternatives that might offer quicker recovery times and less invasive options for women suffering from SUI.

What evidence suggests that this trial's treatments could be effective for stress incontinence?

This trial will compare the effectiveness of two treatments for stress urinary incontinence (SUI): the retropubic midurethral sling (RP-MUS) and urethral bulking with polyacrylamide hydrogel (PAHG). Studies have shown that RP-MUS effectively treats SUI, with success rates ranging from 86% to 99%, and many patients experience significant long-term improvement. Research indicates that RP-MUS can provide lasting results even 20 to 25 years after the procedure. Meanwhile, PAHG is also valuable for women with SUI, having proven effective and safe, with good outcomes even after a year. However, PAHG did not surpass tension-free vaginal tape in terms of patient satisfaction. Both treatments have strengths, so effectiveness may depend on individual needs and preferences. ^{4 6 7 8 9}

Who Is on the Research Team?

David Sheyn, MD

Principal Investigator

University Hospitals Cleveland Medical Center

Cecile Ferrando, MD

Principal Investigator

University of California, San Diego

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11052804/

Evaluation of Outcomes Between the Top-down Versus ... The top-down approach to retropubic MUS placement was associated with lower rates of mesh erosion in this population of patients.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0301211525003860

Long-term outcome of the retropubic TVT procedure for ... Retropubic TVT shows durable efficacy for stress urinary incontinence after 20–25 years. 76.3% of patients report significant long-term improvement in symptoms.

3. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00343-8/fulltext

Long-term safety of mid-urethral sling for stress urinary ... Secondary outcomes were the cumulative incidence of MUS removal and section, hospitalization for urinary retention and MUS erosion and infection ...

4. imrpress.com imrpress.com/journal/CEOG/51/9/10.31083/j.ceog5109201/htm

Clinical Outcomes of Mid-Urethral Sling Procedures for the ... Both retropubic and transobturator MUS techniques are effective for managing SUI, with the transobturator approach showing fewer complications and shorter ...

5. nejm.org nejm.org/doi/full/10.1056/NEJMoa0912658

Retropubic versus Transobturator Midurethral Slings for ... The success rates of this procedure that have been reported in trials range from 86% to 99%, and a large, multicenter, randomized trial showed ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12496164/

Long-term safety of mid-urethral sling for stress urinary ... Five-year results of a randomized trial comparing retropubic and transobturator midurethral slings for stress incontinence. Eur Urol. 2014 ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1553465023009718

Safety and Efficacy Report for the Use of Poly-4 ... Preliminary evidence suggests that a sling made of P4HB can be safely used for MUS procedures and could be an alternative for permanent polypropylene slings.

8. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9695694/

Clinical Outcomes of Mid-Urethral Sling (MUS) Procedures ... The presented research confirms the safety and efficacy of retropubic and transobturator tape methods in both short- and long-term follow-up—the success rate ...

9. clinicaltrials.gov clinicaltrials.gov/study/NCT03520114

Retropubic vs. Single-Incision Mid-Urethral Sling for Stress ... While retropubic (RP) slings are considered to be the "gold-standard" referent for other slings with long-term outcomes data, they are associated with the ...