Protect Chronic Tibial Nerve Stimulator (CTNS) System

Uro Medical

Status: Terminated

Conditions: Urge Incontinence

Treatments: Device: Device: StimGuard Protect System

Study type: Interventional

Funder types: Industry

Identifiers

NCT02781636

30-00136

Details and patient eligibility

About

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

Full 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.

Enrollment: 10 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of overactive bladder with urgency urinary incontinence

Exclusion criteria

• Primary complaint of stress urinary incontinence

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Chronic Tibial Implant Arm

Experimental group

Description:

StimGuard Protect System (Chronic Tibial Nerve Stimulation) Implant Procedure. Lead implanted adjacent to tibial nerve. Wireless rechargeable system.

Treatment:

Device: Device: StimGuard Protect System