Urge Incontinence
Conditions
Keywords
Efficacy, Implantable, Wireless, Neuromodulation, Device, Tibial
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.
Interventions
DEVICEDevice: StimGuard Protect System
Lead implanted adjacent to tibial nerve. Wireless rechargeable system.
Sponsors
Uro Medical Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of overactive bladder with urgency urinary incontinence
Exclusion criteria
* Primary complaint of stress urinary incontinence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in Urge Incontinence Episodes | 90 days |
Countries
Belgium
Outcome results
None listed