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INTIBIA Pivotal Study

NCT05250908 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 208

Last updated 2026-03-02

No results posted yet for this study

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).

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Coloplast A/S

    lead INDUSTRY

Principal Investigators

  • Catherine Matthews, MD · Wake Forest University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-07
Primary Completion
2025-05-12
Completion
2026-06-27
FDA Device
Yes

Countries

  • United States
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05250908 on ClinicalTrials.gov