Condition: Urinary Incontinence · Delivery Complication · Sponsor: NICHD Pelvic Floor Disorders Network
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.
This description comes directly from the study's public registry record.
Contact details are listed per location below or on the registry record.
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| Kaiser Permanente -- San Diego | San Diego, California, United States | Recruiting |
| University of California - San Diego | San Diego, California, United States | Recruiting |
| University of Chicago | Chicago, Illinois, United States | Recruiting |
| Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery | Durham, North Carolina, United States | Recruiting |
| University of Pennsylvania | Philadelphia, Pennsylvania, United States | Recruiting |
| Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery | Providence, Rhode Island, United States | Recruiting |
| University of Texas Southwestern Medical Center | Dallas, Texas, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06411158