Clinical Trial

INTIBIA Pivotal Study

Active, Not Recruiting
View on ClinicalTrials.gov →
Summary
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).
Protocol Amendment History 15 amendments
This ClinicalTrials.gov record has been amended 15 times since 2022-02-11; most recent amendment 2026-02-28.
Status change: Recruiting → Active, Not Recruiting 2024-09-05
Trial Details
NCT Number NCT05250908
Lead Sponsor Coloplast A/S
Conditions Urinary Incontinence, Urge, Urinary Bladder, Overactive, Urinary Bladder Diseases, Urologic Diseases, Lower Urinary Tract Symptoms, Urological Manifestations
Enrollment 208 participants
Start Date 2022-03-07
Primary Completion 2025-05-12 (estimated)
Study Completion 2026-06-27 (estimated)
Updated on ClinicalTrials.gov 2026-03-02