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Protect Chronic Tibial Nerve Stimulator (CTNS) System

Primary Purpose

Urge Incontinence

Status
Terminated
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Device: StimGuard Protect System
Sponsored by
Uro Medical Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urge Incontinence focused on measuring Efficacy, Implantable, Wireless, Neuromodulation, Device, Tibial

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of overactive bladder with urgency urinary incontinence

Exclusion Criteria:

  • Primary complaint of stress urinary incontinence

Sites / Locations

  • UZA

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Chronic Tibial Implant Arm

Arm Description

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

Outcomes

Primary Outcome Measures

Reduction in Urge Incontinence Episodes

Secondary Outcome Measures

Full Information

First Posted
May 20, 2016
Last Updated
September 4, 2020
Sponsor
Uro Medical Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02781636
Brief Title
Protect Chronic Tibial Nerve Stimulator (CTNS) System
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 Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Terminated
Why Stopped
Replaced by US RCT
Study Start Date
April 2016 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uro Medical Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urge Incontinence
Keywords
Efficacy, Implantable, Wireless, Neuromodulation, Device, Tibial

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Chronic Tibial Implant Arm
Arm Type
Experimental
Arm Description
StimGuard Protect System (Chronic Tibial Nerve Stimulation) Implant Procedure. Lead implanted adjacent to tibial nerve. Wireless rechargeable system.
Intervention Type
Device
Intervention Name(s)
Device: StimGuard Protect System
Other Intervention Name(s)
Chronic Afferent Nerve Stimulation
Intervention Description
Lead implanted adjacent to tibial nerve. Wireless rechargeable system.
Primary Outcome Measure Information:
Title
Reduction in Urge Incontinence Episodes
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of overactive bladder with urgency urinary incontinence Exclusion Criteria: Primary complaint of stress urinary incontinence
Facility Information:
Facility Name
UZA
City
Edegem
ZIP/Postal Code
2650
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Upon Study Completion

Learn more about this trial

Protect Chronic Tibial Nerve Stimulator (CTNS) System

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