TULIP (Urinary Leakage After Pregnancy) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to help women regain bladder strength and function after having their first baby. We want to find out which treatment options work best to stop bladder leakage.
Bladder Leakage
Who Can Participate in the Study?
Women ages 18+ who:
- Delivered their child between 4 and 8 weeks ago
- Have symptomatic, bothersome urinary incontinence
- Are at an increased risk of a pelvic floor disorder based on the presence of at least 1 of the following 3 factors: gave birth to a child weighing more than 8.8 pounds, had an operative delivery (i.e., forceps or vacuum-assisted delivery), or had a 3rd or 4th degree perineal laceration during childbirth
For more information, contact the study team at 919-401-1016 or sky16@duke.edu.
What is Involved?
If you choose to join this study, you will come to our clinic for a baseline visit, which will take between 1-2.5 hours. During this visit, you will:
- Review your medical history with the study team
- Be asked to collect a vaginal swab and urine sample
- Fill out baseline questionnaires
- Have a pelvic exam
If you are not experiencing leakage, you will periodically fill out questionnaires related to your pelvic floor and bladder symptoms, mail in vaginal swab samples, and return for a 6 month follow up visit.
If you are experiencing leakage, you will be randomly assigned to 1 of 3 study groups:
- Group 1: If you are in this group, a skilled provider will teach you how to do a variety of pelvic muscle exercises. You will have up to 2 in-person visits with a provider and get a home exercise plan.
- Group 2: If you are in this group, you will receive a home exercise plan to strengthen your pelvic muscles. You will also get an electronic exercise device to use at home. This device will communicate through an app and help you do the exercises the right way.
- Group 3: If you are in this group, you will receive educational material about how to train your pelvic muscles. You will not have a device or provider to support your home exercise plan.
Depending on your group assignment, you will be asked to periodically fill out questionnaires related to your pelvic floor and bladder symptoms, and you may be asked to return to the clinic between 2 - 4 times over a one-year period.
If you are not experiencing leakage, you will be asked to periodically fill out questionnaires and submit vaginal swab samples by mail. You will also be asked to return to the clinic one more time six months later.
Each return visit will take about 1 hour.
We will pay you for your time on the study, and you are welcome to bring your baby to all study visits.
Study Details
