Protect Chronic Tibial Nerve Stimulator (CTNS) System

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02781636
Recruitment Status : Enrolling by invitation
First Posted : May 24, 2016
Last Update Posted : December 28, 2016
Information provided by (Responsible Party):
StimGuard, LLC.

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

Condition or disease Intervention/treatment Phase
Urge Incontinence Device: Device: StimGuard Protect System Phase 2

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A European Trial to Assess the Efficacy of an Implantable Wireless Neuromodulation Device at the Tibial Nerve to Treat Urinary Urgency Incontinence
Study Start Date : April 2016
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : December 2017

Arm Intervention/treatment
Experimental: Chronic Tibial Implant Arm
StimGuard Protect System (Chronic Tibial Nerve Stimulation) Implant Procedure. Lead implanted adjacent to tibial nerve. Wireless rechargeable system.
Device: Device: StimGuard Protect System
Lead implanted adjacent to tibial nerve. Wireless rechargeable system.
Other Name: Chronic Afferent Nerve Stimulation

Primary Outcome Measures :
  1. Reduction in Urge Incontinence Episodes [ Time Frame: 90 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of overactive bladder with urgency urinary incontinence

Exclusion Criteria:

  • Primary complaint of stress urinary incontinence

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02781636

Edegern, Belgium, 2650
Sponsors and Collaborators
StimGuard, LLC.
Study Director: Ailyn Chapman StimGuard, LLC.

Responsible Party: StimGuard, LLC. Identifier: NCT02781636     History of Changes
Other Study ID Numbers: 30-00136
First Posted: May 24, 2016    Key Record Dates
Last Update Posted: December 28, 2016
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Upon Study Completion

Keywords provided by StimGuard, LLC.:

Additional relevant MeSH terms:
Urinary Incontinence, Urge
Urinary Incontinence
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms