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Single-Incision vs Retropubic Sling for Stress Urinary Incontinence (SASS Trial)

N/A

Recruiting

Led By Catherine A Matthews, MD

Research Sponsored by Wake Forest University Health Sciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

At least 21 years of age

Vaginal bulge symptoms as indicated by an affirmative response of >1 to question 3 of the PFDI-SF20

Must not have

Poorly-controlled diabetes mellitus (HgbA1c > 9 within 3 months of surgery date)

Current genitourinary fistula or urethral diverticulum

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, surgery, post op: week 2, week 6, year 1, year 2, year 3, and year 5

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effectiveness of a single-incision sling versus a retropubic sling for treating stress urinary incontinence during minimally invasive sacrocolpopexy.

Who is the study for?

Women over 21 with vaginal bulge symptoms, pelvic organ prolapse stage II or higher, and stress urinary incontinence are eligible. They must be able to consent, complete questionnaires, and return for follow-ups. Exclusions include neurogenic bladder issues, high post-void residuals, pregnancy plans, serious interfering conditions, unwillingness to have a synthetic sling, unresolved UTI's or poorly-controlled diabetes.

What is being tested?

The SASS trial is testing two surgical methods for treating stress urinary incontinence during minimally invasive sacrocolpopexy: the Single-incision Sling (SIS) versus the Retropubic Mid-Urethral Sling (RP Sling). It's a multicenter study where participants are randomly assigned to one of these treatments without knowing which one they receive.

What are the potential side effects?

Potential side effects may include discomfort at the incision site, bleeding or bruising around the area of surgery; there could also be risks related to anesthesia. Specific side effects related to each procedure will vary and can be discussed with healthcare providers.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 21 years old.

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I feel a bulge in my vagina, as per the PFDI-SF20 survey.

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My pelvic organ prolapse is at least stage II with apical descent.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I have a current issue with abnormal connections in my urinary tract.

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I have had radiation therapy to my pelvic area before.

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I have had surgery for urinary leakage.

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I have inflammatory bowel disease.

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I use self-catheterization due to bladder issues.

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I do not want a synthetic sling.

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I have a current urinary tract infection that hasn't been treated.

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I am scheduled for surgery related to bowel issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, surgery, post op: week 2, week 6, year 1, year 2, year 3, and year 5

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, surgery, post op: week 2, week 6, year 1, year 2, year 3, and year 5

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, surgery, post op: week 2, week 6, year 1, year 2, year 3, and year 5 for reporting.