INTIBIA Pivotal Study
Public ClinicalTrials.gov record NCT05250908. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Randomized Clinical Trial Evaluating INTIBIA, an Investigational Implantable Tibial Nerve Stimulator, Through 24-Months (INTIBIA Pivotal Study IU024)
Study identification
- NCT ID
- NCT05250908
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Not applicable
- Lead sponsor
- Coloplast A/S
- Industry
- Enrollment
- 208 participants
Conditions and interventions
Conditions
Interventions
- INTIBIA Non-Therapeutic Device
- INTIBIA Therapeutic Device
Device
Eligibility (public fields only)
- Age range
- 22 Years to 80 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 6, 2022
- Primary completion
- May 11, 2025
- Completion
- Jun 26, 2026
- Last update posted
- Mar 1, 2026
2022 – 2026
United States locations
- U.S. sites
- 20
- U.S. states
- 14
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Cedars-Sinai Medical Group | Beverly Hills | California | 90211 | — |
| Urology Group of Southern California | Los Angeles | California | 90017 | — |
| MedStar Washington Hospital Center | Washington D.C. | District of Columbia | 20010 | — |
| Advanced Urology Associates | Daytona Beach | Florida | 32114 | — |
| Southeastern Urogynecology & Pelvic Surgery | Moultrie | Georgia | 31768 | — |
| Rosemark WomenCare Specialists | Idaho Falls | Idaho | 83402 | — |
| Cypress Medical Research Center, LLC | Wichita | Kansas | 67226 | — |
| Baystate Medical Center | Springfield | Massachusetts | 01199 | — |
| University of Michigan | Ann Arbor | Michigan | 48109 | — |
| Advanced Urogynecology of Michigan | Dearborn | Michigan | 48124 | — |
| Specialty Clinical Research of St. Louis | St Louis | Missouri | 63141 | — |
| Atlantic Health System - AMG Urology (Garden State Urology) | Denville | New Jersey | 07834 | — |
| Wake Forest University | Winston-Salem | North Carolina | 27103 | — |
| The Urology Group | Cincinnati | Ohio | 45212 | — |
| MetroHealth System | Cleveland | Ohio | 44109 | — |
| The Institute for Female Pelvic Medicine and Reconstructive Surgery- Axia Womens Health | Allentown | Pennsylvania | 18103 | — |
| MidLantic Urology | Bala-Cynwyd | Pennsylvania | 19004 | — |
| The Female Pelvic Health Center | Newtown | Pennsylvania | 18940 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Houston Metro Urology | Houston | Texas | 77027 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05250908, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 1, 2026 · Synced May 18, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05250908 live on ClinicalTrials.gov.