NCT02781636

Protect Chronic Tibial Nerve Stimulator (CTNS) System

A European Trial to Assess the Efficacy of an Implantable Wireless Neuromodulation Device at the Tibial Nerve to Treat Urinary Urgency Incontinence

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Uro Medical Corporation · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Urge Incontinence

Interventions

Type	Name	Description
DEVICE	Device: StimGuard Protect System	Lead implanted adjacent to tibial nerve. Wireless rechargeable system.

Timeline

• Start date: 2016-04-01
• Primary completion: 2017-09-01
• Completion: 2017-09-01
• First posted: 2016-05-24
• Last updated: 2020-09-09

Locations

1 site across 1 country: Belgium