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.
Who Can Participate?
Eligibility
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
Age Range
18-110
Sex/Genders
Female (cisgender)
Non-binary or gender fluid
Transgender male
Looking for Healthy Participants
Yes
What is Involved?
Description
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
- 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.
Locations
Duke University Hospital
Duke Regional Hospital
Duke Raleigh Hospital
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
Training for Urinary Leakage Improvement after Pregnancy
Study Website
Principal Investigator
Nazema
Siddiqui
Protocol Number
PRO00115138
NCT ID
NA
Phase
N/A
Enrollment Status
Open to Enrollment