Conditions: Urinary Incontinence
Keywords: Stress urinary incontinence, Mixed, Urge
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 27
Healthy volunteers: yes

Brief 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.

Detailed description:
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.

Arms:
arm 1: Surgical treatment will consist of the following evidence-based stress incontinence procedures: mid-urethral slings (TVT, TOT, TVT-O), fascial slings, and Burch colposuspension. arm 2: The non-surgical treatment will include two components:

1. Pharmacological therapy with any FDA approved overactive bladder (OAB) drug in approved doses; and
2. Behavioral therapy.

Interventions: intervention 1: Non-Surgical Intervention intervention 2: Surgical
Intervention descriptions: intervention 1: Both oral urge incontinence medication and behavioral treatment intervention 2: Initial surgical (stress incontinence surgery) treatment approach.

Protocol document: