TULIP (TULIP)
Brief description of study
Millions of women worldwide have accidental leakage of urine they cannot control after giving birth. Dealing with this problem can be embarrassing and can even add to feelings of anxiety or depression. If you are experiencing this sort of bothersome accidental bladder leakage, the University of Pennsylvania Health System care team is here to help. A group of doctors and researchers have developed a program, funded by the U.S. National Institutes of Health, to help these new moms. This research study, called Training for Urinary Leakage Improvement after Pregnancy or “TULIP,” is designed to learn more about what treatment options can work best for new moms with bothersome accidental bladder leakage.
Detailed description of study
Patients who agree to participate in TULIP get assigned to various treatment options. All moms get specialized education on how to strengthen their pelvic muscles to support their bladder and try and lessen their leakage. Some moms get assigned to additional teaching, either with two in-person muscle strengthening sessions (like having your own exercise coach), or with an at-home pelvic muscle exercise device (a wireless vaginal insert that communicates with an app on your phone to help you learn when correct exercises are being performed.)
Participants will begin the study about 4 to 8 weeks after delivering their first baby and will continue contributing to the study until 12 months postpartum. You will be asked to complete questionnaires about your general health and urinary symptoms using a research-based smartphone app. Additionally, you will also be asked to attend 3 to 4 clinic visits throughout the course of the study.
If you are eligible and choose to participate in the year-long study, you will 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.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Medical Research
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Age: 18 Years
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Gender: Female
- You are 18 years of age or older, and have delivered your first baby in the last 4 to 8 weeks, without the need for cesarean section 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 and,
- You are currently experiencing bothersome urinary incontinence symptoms.
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What happens next?
- You can expect the study team to contact you via email or phone in the next few days.
- Sign up as volunteer to help accelerate the development of new treatments and to get notified about similar trials.
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