We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Protect Chronic Tibial Nerve Stimulator (CTNS) System

This study is enrolling participants by invitation only.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02781636
First Posted: May 24, 2016
Last Update Posted: December 28, 2016
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.
Information provided by (Responsible Party):
StimGuard, LLC.
  Purpose
30 patient Study. All patients implanted with StimGuard Protect System. Patient followed out to 90 days.

Condition Intervention Phase
Urge Incontinence Device: Device: StimGuard Protect System Phase 2

Study Type: Interventional
Study Design: 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

Further study details as provided by StimGuard, LLC.:

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

Estimated Enrollment: 10
Study Start Date: April 2016
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

Inclusion Criteria:

  • Diagnosis of overactive bladder with urgency urinary incontinence

Exclusion Criteria:

  • Primary complaint of stress urinary incontinence
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02781636


Locations
Belgium
UZA
Edegern, Belgium, 2650
Sponsors and Collaborators
StimGuard, LLC.
Investigators
Study Director: Ailyn Chapman StimGuard, LLC.
  More Information

Responsible Party: StimGuard, LLC.
ClinicalTrials.gov Identifier: NCT02781636     History of Changes
Other Study ID Numbers: 30-00136
First Submitted: May 20, 2016
First Posted: May 24, 2016
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.:
Efficacy
Implantable
Wireless
Neuromodulation
Device
Tibial

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