INTIBIA Pivotal Study

Status Recruiting

Clinical Trial 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).

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05250908
Study type	Interventional
Source	Coloplast A/S
Contact	Lisa Draper
Phone	6123442316
Email	usldr@coloplast.com
Status	Recruiting
Phase	N/A
Start date	March 7, 2022
Completion date	March 7, 2025

View Details

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