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What is Accidental Urine Leakage?
Urinary incontinence (UI)—i.e., involuntary leakage of urine—is a common condition that affects many participants after pregnancy, with prevalence rates ranging from 25-45% during pregnancy and approximately 33% after delivery.
What are we studying?
We are inviting you to participate in this research study because you recently delivered a baby and are now experiencing bladder leakage, which is a very common problem that can be bothersome for new mothers. This research study is being conducted to compare three different treatment strategies for improving urinary leakage using your pelvic muscles, which support your bladder:
- Patient Education: Detailed information and instructions about lifestyle changes and pelvic muscle exercises that may improve accidental bladder leakage.
- Pelvic Floor Muscle Therapy (PFMT): Coaching sessions with a skilled provider to learn and practice pelvic muscle exercises.
- Pelvic Muscle Exercises with Leva®: Exercises guided by an at-home motion-based vaginal insert device (Leva®) that connects wirelessly with a smartphone app to inform the user when correct exercises are being performed.
How many people will participate in this study?
About 216 participants will be asked to participate in the “TULIP” Study at 6 university health systems nationwide. About 36 participants will be asked to participate at Women & Infants. Women & Infants is part of the Pelvic Floor Disorders Network (PFDN), a team of doctors and researchers from clinical research centers around the country.
Participating sites:
- University of California San Diego
- Kaiser Permanente Southern Region
- Duke University
- University of Chicago
- University of Pennsylvania
- University of Texas Southwestern
- Women & Infants Hospital of Rhode Island
Will I be compensated?
- If you are eligible and choose to participate in the year-long study, you may be paid up to a total of $375 or $500 for completing all study visits and questionnaires, depending on which treatment group you are assigned to.
- This compensation is to partially cover your personal time and expenses (transportation parking) related to your study participation.
You may be eligible to participate if:
- You are 18 years of age or older, and have delivered your first baby (without the need for a cesarean) in the last 4 to 8 weeks, and
- Your baby was large at birth - 8.8 pounds or more, and/or your delivery was assisted with the use of forceps or vacuum, and/or you experienced a 3rd or 4th degree tear during delivery. (These factors mean that you are at an increased risk of ongoing pelvic floor disorders) and
- You are currently experiencing bothersome urinary incontinence symptoms.
Contact information:
If you are interested in learning more about this study and to find out if you are able to participate, please contact a member of the research team:
