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.
• ≥18yo primiparous patient s/p singleton vaginal delivery (\>32 weeks), approximately 6wk postpartum
• At increased risk of sustained pelvic floor disorders, as defined by
‣ neonate ≥3.5kg, and/or
⁃ operative delivery (i.e., forceps or vacuum-assisted vaginal delivery), and/or
⁃ ≥2nd-degree perineal laceration
• Symptomatic, bothersome UI as defined by a score of ≥6 on the ICIQ-SF.