Combined Treatment for Mixed Incontinence

Completed · Phase 3

Conditions studied: Urinary Incontinence, Stress, Urinary Incontinence, Urge

In brief

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.

Key facts

Study ID

NCT01959347

Run by

NICHD Pelvic Floor Disorders Network

People needed

480

Starts

2013-10-28

Expected to finish

2017-09-29

Last updated by the study team

2020-05-14

Who can join

Age: 21 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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
• Subjects understand that BPTx is a treatment option for MUI outside of ESTEEM study protocol
• Urodynamics within past 18 months

You may not qualify if…

• Anterior or apical compartment prolapse at or beyond the hymen (>0 on POPQ), regardless if patient is symptomatic
• a)Women with anterior or apical prolapse above the hymen (<0) who do not report vaginal bulge symptoms will be eligible
• Planned concomitant surgery for anterior vaginal wall or apical prolapse > 0
• a)Women undergoing only rectocele repair are eligible
• Women undergoing hysterectomy for any indication will be excluded
• Active pelvic organ malignancy
• Age <21 years
• Pregnant or plans for future pregnancy in next 12 months, or within 12 months post-partum
• Post-void residual >150 cc on 2 occasions, or current catheter use
• Participation in other trial that may influence results of this study
• Unevaluated hematuria
• Prior sling, synthetic mesh for prolapse, implanted nerve stimulator for incontinence
• Spinal cord injury or advanced/severe neurologic conditions including Multiple Sclerosis, Parkinsons
• Women on anti-muscarinic therapy will be eligible after 3 week wash-out period
• Non-ambulatory
• History of serious adverse reaction to synthetic mesh
• Not able to complete study assessments per clinician judgment, or not available for 12 month follow-up
• Women who only report "other IE" on bladder diary, and do not report at minimum 1 stress and 1 urge IE/3 days
• Diagnosis of and/or history of bladder pain or chronic pelvic pain
• Women who had intravesical Botox injection within the past 12 months

Where it is running

• University of Alabama at Birmingham, Department of Obstetrics and Gynecology — Birmingham, Alabama, United States
• Kaiser Permanente -- Downey — Downey, California, United States
• University of California at San Diego, UCSD Women's Pelvic Medicine Center — La Jolla, California, United States
• Kaiser Permanente -- San Diego — San Diego, California, United States
• University of New Mexico Health Sciences Center, Department of Obstetrics and Gynecology — Albuquerque, New Mexico, United States
• Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery — Durham, North Carolina, United States
• Cleveland Clinic, Department OB/GYN — Cleveland, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Magee-Womens Hospital, Department of Obstetrics and Gynecology — Pittsburgh, Pennsylvania, United States
• Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery — Providence, Rhode Island, United States

Full record on ClinicalTrials.gov

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