Therapy for Mixed Urinary Incontinence
The Women's Health Clinical Research Center at University of Pennsylvania is currently recruiting healthy women, over the age of 21, who are experiencing urinary leakage due to BOTH stress and urgency, also known as mixed urinary incontinence (MUI). Stress urinary incontinence (SUI) is when you leak urine with sneezing, coughing, and/or physical activity. Urgency urinary Incontinence (also called overactive bladder (UUI)) is when you feel a sudden, strong desire to pass urine that results in leakage before reaching the toilet. Because MUI includes both types of incontinence (stress and urgency), it is difficult to treat. This study will compare 2 different methods for the treatment of MUI: BOTOX ® injections in the bladder for treating UUI or mid-urethral sling (sling) surgery for treating SUI. Both of these procedures are standard of care for mixed urinary incontinence and are not experimental. In this study we are trying to determine which treatment is best to treat women who have both types of incontinence.
If you decide to join this study, you will be randomized (like a flip of a coin) to receive treatment for your MUI with either BOTOX injection in the bladder or mid-urethral sling surgery. BOTOX helps to treat UUI by preventing bladder spasms that cause leakage. The use of BOTOX is currently approved by the FDA to treat conditions like overactive bladder including UUI. Mid-Urethral Sling (MUS) is a surgical treatment for MUI where a small piece of permanent mesh is placed under the urethra. MUS is primarily used for treating SUI, but they might also help UUI in women who have MUI. Surgery will be done at either Pennsylvania Hospital or Presbyterian Hospital; BOTOX injection will be done in the Clinic at Penn Medicine Washington Square or Penn Medicine University City.
Two weeks after your procedure, you will be scheduled for a follow-up Clinic visit. You will also be scheduled for Clinic visits, 3 months and 6 months after treatment, to assess your symptoms. Each visit will take about 1 hour. At different intervals during the study you will be asked to complete a 3-day bladder diary, as well as, study questionnaires. Participation in this study will be for a duration of approximately 9 months.
The University of Pennsylvania is one of seven clinical research centers, around the country, who are participating in this exciting research. The study is being sponsored by The Pelvic Floor Disorders Network (PFDN). The PFDN is funded by the National Institutes of Health and strives to improve the level of knowledge about pelvic floor disorders such as urinary incontinence, pelvic organ prolapse, and accidental bowel leakage.
If you would like more information about this study, or are interested in participating in the study, please contact the Urogynecology Research Team at 267-785-8068 or email Yelizaveta.firstname.lastname@example.org.