Formal Study NameEffects of Surgical Treatment Enhanced with Exercise for Mixed Urinary Incontinence
Studying therapies to treat mixed urinary incontinence
Primary Principal InvestigatorVivian Sung
The ESTEEM Study will compare two approaches for treating mixed urinary incontinence (MUI) in women. MUI involves both stress urinary incontinence (SUI), leaking urine when laughing, coughing and sneezing, and urge urinary incontinence (UUI), leaking urine on the way to the bathroom or with a sense of urgency.
The two approaches are:
- A midurethral sling alone.
- A midurethral sling combined with behavioral pelvic floor muscle therapy before and after surgery.
Participation will last up to one year after surgery.
You may be eligible to participate in this study if you:
- Are a woman who reports symptoms of MUI.
- Are 21 years of age or older.
- Desire surgical treatment for your urinary incontinence.
- Have not had a previous bladder surgery with mesh.
Why is this study important?
Many women experience bothersome urine loss with laughing, coughing and sneezing (SUI) AND on their way to the bathroom (UUI). When women experience both types of urine leakage, their condition is called mixed urinary incontinence (MUI). Because MUI involves both types of incontinence, it is difficult to treat. A common surgical treatment for SUI alone is a midurethral sling. Behavioral/pelvic floor therapy has also been shown to help both types of incontinence. It is hard to treat both forms of incontinence at the same time.. This study will evaluate whether combining surgery and behavioral/pelvic floor therapy works better for treating MUI compared to having surgery alone.
What will I be asked to do?
Urodynamics, a routine bladder evaluation, will be required prior to study enrollment.
- Complete a three-day bladder diary (a daily record of your voids and episodes of urinary leakage) and complete questionnaires to determine if you are eligible.
- If you are eligible, you will be randomly assigned, like the flip of a coin, to either receive a midurethral sling alone or a midurethral sling with behavioral/pelvic floor therapy before and after your surgery.
- Your study participation will last approximately one year after your surgery and will include in-person visits, telephone calls, completion of questionnaires, and three-day bladder diaries.
- You will receive financial compensation for completed visits, calls, questionnaires and diaries.
What happens to the information collected about me?
All research information will be treated confidentially. All of your study forms will be assigned a number, not your name.
Can I drop out of the study once I have begun?
Yes. Participation in the study is completely voluntary, and you may remove yourself from the study at any point. If you decide to drop out of the study, medical care will continue to be provided to you if you would like.
What will the study cost me?
There are no additional costs to you for study procedures during your participation. Any medical care that you require outside of the scope of the study will be charged to you or your insurance company in the usual way. If you are randomized to receive behavioral/pelvic floor therapy before and after your surgery, the study will cover the cost of your sessions with a behavioral/pelvic floor therapy specialist.
What is the Pelvic Floor Disorders Network?
The Pelvic Floor Disorders Network (PFDN) is a team of doctors and researchers from eight clinical research centers around the country funded by the National Institutes of Health to improve the level of knowledge about pelvic floor disorders such as an overactive bladder. Through research studies, the team will be able to identify the most effective ways to care for women.
Women & Infants Hospital is proud to be a member of the PFDN.
Women & Infants