Training for Urinary Leakage Improvement After Pregnancy
Recruiting now · Not applicable
Conditions studied: Urinary Incontinence, Delivery Complication
In brief
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.
Key facts
- Study ID
- NCT06411158
- Run by
- NICHD Pelvic Floor Disorders Network
- People needed
- 216
- Starts
- 2024-11-12
- Expected to finish
- 2027-11-12
- Last updated by the study team
- 2025-12-31
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- ≥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.
You may not qualify if…
- 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
- Severe pain with assessments of PFM integrity and/or strength/function
- Already engaged (since delivery) in in-person physical therapy for strengthening of the pelvic floor
- Unwilling or unable to upload and use external smartphone app(s)
Where it is running
- Kaiser Permanente -- San Diego — San Diego, California, United States (enrolling)
- University of California - San Diego — San Diego, California, United States (enrolling)
- University of Chicago — Chicago, Illinois, United States (enrolling)
- Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery — Durham, North Carolina, United States (enrolling)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
- Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery — Providence, Rhode Island, United States (enrolling)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (enrolling)
Full record on ClinicalTrials.gov
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