Training for Urinary Leakage Improvement After Pregnancy (NCT06411158)
🩺 Plain-English Summary (8th-Grade Level)
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 join: Review the eligibility criteria below.
Location: Kaiser Permanente -- San Diego — San Diego, California
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (7 Sites)
- Kaiser Permanente -- San Diego — San Diego, California
- University of California - San Diego — San Diego, California
- University of Chicago — Chicago, Illinois
- Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery — Durham, North Carolina
- University of Pennsylvania — Philadelphia, Pennsylvania
- Brown/ Women and Infants Hospital of Rhode Island, Center for Women's Pelvic Medicine and Reconstructive Surgery — Providence, Rhode Island
- University of Texas Southwestern Medical Center — Dallas, Texas
📞 Contact the Study Coordinator
Phone: (619) 821-5717
Email: gisselle.zazueta-damian@kp.org
Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
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- Clinical Study of External Electrical Stimulation for Male Incontinence — Monroe, Connecticut
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- WI-INTUIT: Bridging Community Based Continence Promotion and Primary Care — San Diego, California
Explore by condition: All Urinary Incontinence clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Contact the study coordinator using the phone/email above.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.