Combined Treatment for Mixed Incontinence (NCT01959347) | Clinical Trial Compass
CompletedPhase 3
Combined Treatment for Mixed Incontinence
United States480 participantsStarted 2013-10-28
Plain-language summary
The overarching goal of this randomized trial is to estimate the effect of combined midurethral sling (MUS) and peri-operative behavioral/pelvic floor therapy (BPTx) compared to MUS alone on successful treatment of MUI symptoms in 472 women. Secondary objectives include estimating the effect of combined treatment compared to MUS on improving overactive bladder (OAB) and stress urinary incontinence (SUI) outcomes separately, need for additional treatment, time to failure and identifying predictors of poor outcomes in this MUI population.
A supplemental study, The Human Microbiome Study of ESTEEM, will evaluate the urinary and vaginal microbiome as it relates to women with MUI, their treatment and unaffected controls.
Who can participate
Age range21 Years
SexFEMALE
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Inclusion criteria
✓. Presence of both SUI and UUI on bladder diary; and \> 2 IEs/3 days
✓. \> 1 Stress IE/3 day diary
✓. \> 1 Urge IE/3 day diary
✓. Reporting at least "moderate bother" from UUI item on the UDI "Do you usually experience urine leakage associated with a feeling of urgency, that is a strong sensation of needing to go to the bathroom?"
✓. Reporting at least "moderate bother" from SUI item on UDI "Do you usually experience urine leakage related to coughing, sneezing, or laughing"
✓. Diagnosis of SUI defined by a positive cough stress test (CST) or urodynamic evaluation within the past 18 months
✓. Desires surgical treatment for SUI symptoms
✓. Urinary symptoms \>3 months
Exclusion criteria
✕. Anterior or apical compartment prolapse at or beyond the hymen (\>0 on POPQ), regardless if patient is symptomatic