Actively Recruiting
Training for Urinary Leakage Improvement After Pregnancy
Led by NICHD Pelvic Floor Disorders Network · Updated on 2025-12-31
216
Participants Needed
7
Research Sites
156 weeks
Total Duration
On this page
Sponsors
N
NICHD Pelvic Floor Disorders Network
Lead Sponsor
E
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is a multi-center, randomized single-blind nonsurgical trial conducted in approximately 216 primiparous postpartum women at high risk for prolonged/sustained pelvic floor disorders with symptomatic, bothersome urinary incontinence (UI) amenable to nonsurgical treatment. TULIP is a 3-Arm trial with two active interventions (Arms 1 and 2) and a Patient Education control arm (Arm 3). Arm 1 consists of pelvic floor muscle training (PFMT). Arm 2 uses a home biofeedback device (leva®). The primary outcome will be assessed at 6 months postpartum by blinded outcomes assessors, and follow-up will continue until 12 months postpartum.
CONDITIONS
Official Title
Training for Urinary Leakage Improvement After Pregnancy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female first-time mothers aged 18 years or older, approximately 6 weeks after a single vaginal delivery after more than 32 weeks of pregnancy
- At increased risk for pelvic floor disorders defined by at least one of the following: baby weighing 3.5 kg or more, operative vaginal delivery (forceps or vacuum), or second-degree or greater perineal tear
- Experiencing bothersome urinary incontinence with a score of 6 or higher on the ICIQ-SF questionnaire
You will not qualify if you...
- Unable to complete study procedures or unavailable for 6-month postpartum follow-up
- History of stillbirth or serious maternal or newborn illness
- Does not speak English or Spanish
- Presence of perineal wound breakdown or cloaca on exam
- Severe pain during pelvic floor muscle assessments
- Currently receiving in-person physical therapy for pelvic floor strengthening since delivery
- Unwilling or unable to use a smartphone app for study exercises
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Kaiser Permanente -- San Diego
San Diego, California, United States, 92110
Actively Recruiting
2
University of California - San Diego
San Diego, California, United States, 92121
Actively Recruiting
3
University of Chicago
Chicago, Illinois, United States, 60637
Actively Recruiting
4
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, North Carolina, United States, 27707
Actively Recruiting
5
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
6
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
Providence, Rhode Island, United States, 02903
Actively Recruiting
7
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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