NCT05250908

INTIBIA Pivotal Study

A Prospective, Randomized Clinical Trial Evaluating INTIBIA, an Investigational Implantable Tibial Nerve Stimulator, Through 24-Months (INTIBIA Pivotal Study IU024)

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 208 (actual)
• Sponsor: Coloplast A/S · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

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).

Detailed description

All eligible subjects will be implanted with the INTIBIA device. Subjects will be randomized to either INTIBIA therapeutic or INTIBIA non-therapeutic in a 2:1 ratio for the first 3 months of the study, at which point all subjects will receive therapeutic stimulation. Subjects will complete voiding diaries and questionnaires at Baseline and prior to each follow-up visit, which will occur at Months 3, 6, 12, and 24. Subjects will be offered to keep the device or have it explanted at the end of the study.

Conditions

• Urinary Incontinence, Urge
• Urinary Bladder, Overactive
• Urinary Bladder Diseases
• Urologic Diseases
• Lower Urinary Tract Symptoms
• Urological Manifestations

Interventions

Type	Name	Description
DEVICE	INTIBIA Therapeutic	INTIBIA implantable tibial nerve stimulator with therapeutic stimulation
DEVICE	INTIBIA Non-Therapeutic	INTIBIA implantable tibial nerve stimulator with non-therapeutic stimulation for 3 months, then therapeutic stimulation

Timeline

• Start date: 2022-03-07
• Primary completion: 2025-05-12
• Completion: 2026-06-27
• First posted: 2022-02-22
• Last updated: 2026-03-02

Locations

22 sites across 2 countries: United States, Netherlands

Regulatory

• FDA-regulated device study