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Training for Urinary Leakage Improvement After Pregnancy

Study acronym: TULIP
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Site details revised at 1 of 7 sitesv6
  2. Primary completion date: Nov 12, 2027 to May 12, 2027v5
  3. Secondary endpoints: 12 to 5
    • Study description shortened, about 61 words
    • Site contacts updated at 4 of 7 sites
    • Eligibility criteria shortened, about 2 words
    v4
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jul 15, 2024 to Nov 12, 2024
    • Primary and study completion dates: Jul 15, 2027 to Nov 12, 2027
    • Site details revised at 7 of 7 sites
    v3
  5. Start date: Jun 1, 2024 to Jul 15, 2024
    • Primary and study completion dates: Jun 1, 2027 to Jul 15, 2027
    • Eligibility criteria expanded, about 21 words
    • Study description expanded, about 2 words
    v2
  6. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06411158
Lead Sponsor NICHD Pelvic Floor Disorders Network
Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Duke University, Kaiser Permanente, University of California, San Diego, University of Chicago, University of Pennsylvania, University of Texas Southwestern Medical Center, Women and Infants Hospital of Rhode Island, RTI International
Conditions
(from sponsor)		 Urinary Incontinence, Delivery Complication
Related terms Encopresis, Pelvic Floor Disorders, Urinary Incontinence
Enrollment 216 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov