Protect Chronic Tibial Nerve Stimulator (CTNS) System

Uro Medical Corporation10 enrolled

Overview

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

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Urge Incontinence

Interventions

Device: StimGuard Protect SystemDEVICE

Lead implanted adjacent to tibial nerve. Wireless rechargeable system.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Diagnosis of overactive bladder with urgency urinary incontinence Exclusion Criteria: * Primary complaint of stress urinary incontinence

Locations (1)

UZA

Edegem, Belgium

Outcomes

Primary Outcomes

Reduction in Urge Incontinence Episodes

Time frame: 90 days

Data from ClinicalTrials.gov

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