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Protect Chronic Tibial Nerve Stimulator (CTNS) System

NCT ID: NCT02781636

Last Updated: 2020-09-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2017-09-30

Brief Summary

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

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Detailed Description

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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

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Urge Incontinence

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Chronic Tibial Implant Arm

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

Group Type EXPERIMENTAL

Device: StimGuard Protect System

Intervention Type DEVICE

Lead implanted adjacent to tibial nerve. Wireless rechargeable system.

Interventions

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Device: StimGuard Protect System

Lead implanted adjacent to tibial nerve. Wireless rechargeable system.

Intervention Type DEVICE

Other Intervention Names

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Chronic Afferent Nerve Stimulation

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of overactive bladder with urgency urinary incontinence

Exclusion Criteria

* Primary complaint of stress urinary incontinence
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uro Medical Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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UZA

Edegem, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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30-00136

Identifier Type: -

Identifier Source: org_study_id

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