Training for Urinary Leakage Improvement After Pregnancy

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.

NCT Number	NCT06411158
Lead Sponsor	NICHD Pelvic Floor Disorders Network Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Duke University, Kaiser Permanente, University of California, San Diego, University of Chicago, University of Pennsylvania, University of Texas Southwestern Medical Center, Women and Infants Hospital of Rhode Island, RTI International
Conditions	Urinary Incontinence, Delivery Complication
Enrollment	216 participants
Start Date	2024-11-12
Primary Completion	2027-05-12 (estimated)
Study Completion	2027-11-12 (estimated)
Updated on ClinicalTrials.gov	2025-12-31