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Active, not recruiting Not applicable Interventional

INTIBIA Pivotal Study

ClinicalTrials.gov ID: NCT05250908

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.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 2:58 PM EDT

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)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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).

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

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 7, 2022 (Actual)
Primary completion
May 12, 2025 (Actual)
Completion
Jun 27, 2026 (Estimated)
Last update posted
Mar 2, 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 2, 2026 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT05250908 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →