NCT06411158 Training for Urinary Leakage Improvement After Pregnancy
| NCT ID | NCT06411158 |
| Status | Recruiting |
| Phase | — |
| Sponsor | NICHD Pelvic Floor Disorders Network |
| Condition | Urinary Incontinence |
| Study Type | INTERVENTIONAL |
| Enrollment | 216 participants |
| Start Date | 2024-11-12 |
| Primary Completion | 2027-05-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 216 participants in total. It began in 2024-11-12 with a primary completion date of 2027-05-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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)
Contact & Investigator
David Rahn, MD
PRINCIPAL INVESTIGATOR
UTSW
Frequently Asked Questions
Who can join the NCT06411158 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Urinary Incontinence. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06411158 currently recruiting?
Yes, NCT06411158 is actively recruiting participants. Visit ClinicalTrials.gov or contact NICHD Pelvic Floor Disorders Network to inquire about joining.
Where is the NCT06411158 trial being conducted?
This trial is being conducted at San Diego, United States, San Diego, United States, Chicago, United States, Durham, United States and 3 additional locations.
Who is sponsoring the NCT06411158 clinical trial?
NCT06411158 is sponsored by NICHD Pelvic Floor Disorders Network. The principal investigator is David Rahn, MD at UTSW. The trial plans to enroll 216 participants.