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NCT02781636 Clinical Trial

Protect Chronic Tibial Nerve Stimulator (CTNS) System

Urge Incontinence Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT02781636
Other study ID # 30-00136
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date April 2016
Est. completion date September 2017

Study information
Verified date September 2020
Source Micron Medical Corporation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Terminated
Enrollment 10
Est. completion date September 2017
Est. primary completion date September 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Diagnosis of overactive bladder with urgency urinary incontinence

Exclusion Criteria:

- Primary complaint of stress urinary incontinence

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Device: StimGuard Protect System
Lead implanted adjacent to tibial nerve. Wireless rechargeable system.

Locations
Country Name City State
Belgium UZA Edegem

Sponsors (1)
Lead Sponsor Collaborator
Micron Medical Corporation

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Reduction in Urge Incontinence Episodes 90 days
See also
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Completed NCT04470765 - Transcutaneous Tibial Nerve Stimulation: the ZIDA Device Equivalence N/A
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Completed NCT03180372 - Hybrid Fractional Laser Treatment for Symptoms of Urinary Incontinence N/A
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Active, not recruiting NCT05308979 - Intradetrusor Botulinum Toxin A for OAB Via 1 Versus 10 Injections: A Randomized Clinical Trial Phase 4
Completed NCT03672461 - A Group-Based Therapeutic Yoga Intervention for Urinary Incontinence in Ambulatory Older Women N/A
Completed NCT01391780 - Pelvic Floor Muscle Evaluation in Women With Stress Urinary and Urgency Urinary Incontinence N/A
Completed NCT03655054 - eCoin for OAB Feasibility Follow-on Study N/A