No phaseActive, not recruiting
INTIBIA Pivotal Study
A Prospective, Randomized Clinical Trial Evaluating INTIBIA, an Investigational Implantable Tibial Nerve Stimulator (INTIBIA Pivotal Study IU024)
- Sponsor
- Coloplast A/S (Industry)
- Enrollment
- 208 enrolled
- Conditions
- Urinary Incontinence, Urge; Urinary Bladder, Overactive; Urinary Bladder Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations
- Interventions
- INTIBIA Therapeutic; INTIBIA Non-Therapeutic
- Ages
- adults, older adults
- Registry
- NCT05250908
Full record on ClinicalTrials.gov
From the registry
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).
Primary outcomes
- Response Rate
History
Study completion expected
Last registry update
Primary completion
Started
Registered