RecruitingNot Applicable

Training for Urinary Leakage Improvement After Pregnancy

United States216 participantsStarted 2024-11-12

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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Inclusion criteria

✓. ≥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.

Exclusion criteria

✕. Inability to complete study assessments or procedures, per clinician judgment, or not available for 6mo postpartum follow-up
✕. Stillbirth or significant maternal or neonatal illness
✕. Non-English or non-Spanish speaking
✕. Perineal wound breakdown or cloaca observed on exam

What they're measuring

Change in urinary incontinence measure by the ICIQ-SF

Timeframe: From baseline to 6 months postpartum

Trial details

NCT IDNCT06411158

SponsorNICHD Pelvic Floor Disorders Network

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2027-05-12

View on ClinicalTrials.gov More Urinary Incontinence trials