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← Trials
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Training for Urinary Leakage Improvement After Pregnancy

RecruitingNAAges 18 Years - anyFemaleNICHD Pelvic Floor Disorders Network
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. ≥18yo primiparous patient s/p singleton vaginal delivery (\>32 weeks), approximately 6wk postpartum 2. At increased risk of sustained pelvic floor disorders, as defined by 1. neonate ≥3.5kg, and/or 2. operative delivery (i.e., forceps or vacuum-assisted vaginal delivery), and/or 3. ≥2nd-degree perineal laceration 3. Symptomatic, bothersome UI as defined by a score of ≥6 on the ICIQ-SF. Exclusion Criteria: 1. Inability to complete study assessments or procedures, per clinician judgment, or not available for 6mo postpartum follow-up 2. Stillbirth or significant maternal or neonatal illness 3. Non-English or non-Spanish speaking 4. Perineal wound breakdown or cloaca observed on exam 5. Severe pain with assessments of PFM integrity and/or strength/function 6. Already engaged (since delivery) in in-person physical therapy for strengthening of the pelvic floor 7. Unwilling or unable to upload and use external smartphone app(s)
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What it tests

  • Interventionist-guided training
  • Home pelvic floor exercises guided by the leva® device
  • Education
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Where

7 sites
Kaiser Permanente -- San Diego
San Diego, United States
University of California - San Diego
San Diego, United States
University of Chicago
Chicago, United States
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, United States
University of Pennsylvania
Philadelphia, United States
Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery
Providence, United States
University of Texas Southwestern Medical Center
Dallas, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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