Mixed Incontinence: Medical Or Surgical Approach? (NCT00803270) | Clinical Trial Compass
TerminatedPhase 4
Mixed Incontinence: Medical Or Surgical Approach?
Stopped: Feasibility Period ended.
United States27 participantsStarted 2008-10
Plain-language summary
The purpose of this study is to compare treatment outcomes for patients with mixed urinary incontinence (MUI) for whom therapy is initiated with surgery to those for whom therapy is initiated with non-surgical treatment. Women who are bothered by symptoms of both stress and urge incontinence will be randomly assigned to initiate treatment with a surgical (surgery for stress incontinence) vs. a non-surgical (drug and behavioral therapy) approach. Follow-up will be a minimum of 12 Months.
Who can participate
Age range21 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Female
✓. Mixed UI as evidenced by stress and urge symptoms reported on MESA (either percent of urge-type symptoms ≥ the percent of stress-type symptoms or urge symptom score ≥7 if stress predominant) followed by report of "moderately" or "greatly"/"quite a bit" bothered to questions 2 and 3 of the 6-item Urinary Distress Index (UDI-6) or questions 16 and 17 of the 20-item Pelvic Fl;oor Distress Index (PFDI-20), respectively (See Appendix C)
✓. Moderate or severe UI as evidenced by the corresponding response on the Patient Global Impression of Severity (PGI-S)
✓. Incontinence symptoms present for at least (3) months\*