🏛️ Verified NIH Record • Updated 2026-02-28
INTIBIA Pivotal Study (NCT05250908)
A Prospective, Randomized Clinical Trial Evaluating INTIBIA, an Investigational Implantable Tibial Nerve Stimulator, Through 24-Months (INTIBIA Pivotal Study IU024)
🔵 Active, Not Recruiting Observational / Diagnostic ⚙️ Medical Device Protocol Sponsor: Coloplast A/S
🩺 Plain-English Summary (8th-Grade Level)
Prospective, randomized, double-blind, multicenter study to evaluate the safety and efficacy of an implantable tibial nerve stimulator in subjects with urgency urinary incontinence (UUI).
Who can join: Review the eligibility criteria below.
Location: Cedars-Sinai Medical Group — Beverly Hills, California
Age range: 22 Years to 80 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 (22 Sites)
- Cedars-Sinai Medical Group — Beverly Hills, California
- Urology Group of Southern California — Los Angeles, California
- MedStar Washington Hospital Center — Washington D.C., District of Columbia
- Advanced Urology Associates — Daytona Beach, Florida
- Southeastern Urogynecology & Pelvic Surgery — Moultrie, Georgia
- Rosemark WomenCare Specialists — Idaho Falls, Idaho
- Cypress Medical Research Center, LLC — Wichita, Kansas
- Baystate Medical Center — Springfield, Massachusetts
- University of Michigan — Ann Arbor, Michigan
- Advanced Urogynecology of Michigan — Dearborn, Michigan
- Specialty Clinical Research of St. Louis — St Louis, Missouri
- Atlantic Health System - AMG Urology (Garden State Urology) — Denville, New Jersey
- Wake Forest University — Winston-Salem, North Carolina
- The Urology Group — Cincinnati, Ohio
- MetroHealth System — Cleveland, Ohio
- The Institute for Female Pelvic Medicine and Reconstructive Surgery- Axia Womens Health — Allentown, Pennsylvania
- MidLantic Urology — Bala-Cynwyd, Pennsylvania
- The Female Pelvic Health Center — Newtown, Pennsylvania
- Thomas Jefferson University — Philadelphia, Pennsylvania
- Houston Metro Urology — Houston, Texas
- Bergman Clinics, Women's Health, Department of Gynecology — Amsterdam,
- Isala Zwolle — Zwolle,
💰 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.
More studies in Urinary Incontinence, Urge
- Mobility and Voiding Exercises in Older Women With Urinary Incontinence (MoVEonUp) — Philadelphia, Pennsylvania
- TReating Incontinence for Underlying Mental and Physical Health — Palo Alto, California
Explore by condition: All Urinary Incontinence, Urge clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.