RP vs. SIS Surgery for Stress Urinary Incontinence

Recruiting in Palo Alto (17 mi)

+7 other locations

Overseen byCatherine Matthews, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Wake Forest University Health Sciences

No Placebo Group

Trial Summary

What is the purpose of this trial?

One in five women will undergo prolapse surgery in their lifetime, and there is a strong correlation between prolapse and urinary incontinence. Pelvic floor surgeons aspire to improve relevant quality of life outcomes for women with pelvic floor disorders while minimizing complications and unnecessary procedures. There has been an experience of disappointment and frustration when a patient returns following POP repair with new symptoms of Stress Urinary Incontinence (SUI) that she ranks as a greater disruption to her quality of life than her original vaginal bulge. 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 highest risks of intra- and post-operative complications including bladder injury, bleeding, and post-operative voiding dysfunction. Single-incision slings (SIS) are the latest iteration in sling development that build upon the benefits of slings but avoid passage through the muscles of the inner thigh. The hypothesis for this study is that single-incision slings (Altis) are non-inferior to Retropubic mid-urethral slings when placed at the time of native tissue vaginal repair.

Research Team

Catherine Matthews, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

This trial is for English-speaking women at least 21 years old with pelvic organ prolapse (POP) stage II or higher and symptoms of stress urinary incontinence. They must be able to consent, return for follow-ups, complete questionnaires, and are considering native tissue vaginal repair. Excluded are those with poorly-controlled diabetes, prior pelvic radiation or surgery for incontinence, serious diseases affecting study compliance, pregnancy plans within a year post-surgery, incarceration status, certain bladder issues or unwillingness to have a synthetic sling.

Inclusion Criteria

I am scheduled for surgery to repair pelvic organ prolapse using my own tissue.

I speak English and can give my consent.

I understand and agree to attend all follow-up appointments.

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Exclusion Criteria

I have had radiation therapy to my pelvic area before.

My diabetes is not well-managed with an HgbA1c over 9.

I am unable to understand or sign the consent form.

See 11 more

Treatment Details

Interventions

Retropubic (RP) Sling (Mid-urethral sling)
Single-Incision Sling (SIS) (Mid-urethral sling)

Trial OverviewThe trial compares two surgical methods for treating stress urinary incontinence: the traditional retropubic (RP) sling placement versus the newer single-incision mid-urethral sling (SIS). It aims to determine if SIS can match RP's effectiveness while reducing complications like bladder injury and voiding dysfunction that may occur with RP slings.

Participant Groups

2Treatment groups

Experimental Treatment

Group I: SIS groupExperimental Treatment1 Intervention

Participants assigned to the single-incision sling (SIS) group will have the SIS placement procedure.

Group II: RP sling groupExperimental Treatment1 Intervention

Participants assigned to the retropubic (RP) sling group will have the RP sling placement procedure.