Protect Chronic Tibial Nerve Stimulator (CTNS) System

Not Applicable

Terminated

• Conditions: Urge Incontinence

• Registration Number: NCT02781636
• Lead Sponsor: Uro Medical Corporation

Brief Summary

30 patient Study. All patients implanted with StimGuard Protect System. Patient followed out to 90 days.

Detailed Description

The proposed therapy is called chronic tibial nerve stimulation (CTNS), which is a low-risk, minimally invasive chronic implant for the treatment of urgency urinary incontinence. CTNS works by the same mechanism as percutaneous tibial nerve stimulation (PTNS), but is provided for chronic use with an implantable device. CTNS treatment involves the placement of a minimally invasive stimulator with an embedded receiver at the tibial nerve. The Protect CTNS System has an external transmitter that activates the implanted stimulator and sends mild electrical pulses to the tibial nerve. These impulses travel to the sacral nerve plexus, the group of nerves at the base of the spine responsible for bladder function. Since stimulation with the Protect CTNS System is chronic it is expected that bladder activity can be changed more quickly and without the frequency of treatments related to PTNS.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-05-20
• Study First Submitted QC: 2016-05-23
• Study First Posted: 2016-05-24
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-04
• Last Update Posted: 2020-09-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Diagnosis of overactive bladder with urgency urinary incontinence

Exclusion Criteria

• Primary complaint of stress urinary incontinence

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Reduction in Urge Incontinence Episodes	90 days

Trial Locations

Locations (1)

UZA; 🇧🇪 Edegem, Belgium