Training for Urinary Leakage Improvement After Pregnancy
Trial Parameters
Eligibility Fast-Check
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Brief Summary
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.
Eligibility Criteria
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)