An interventional study of Device: StimGuard Protect System in Urge Incontinence, sponsored by Uro Medical Corporation. Terminated at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-09-09.
Sponsored by Uro Medical Corporation · Not applicable, Interventional, and Treatment
30 patient Study. All patients implanted with StimGuard Protect System. Patient followed out to 90 days.
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.
204 studies on the registry are indexed under Urinary Incontinence, Urge; 41 are open to participants now.
This study's enrollment of 10 is below the median of 76 across 156 interventional studies indexed under Urinary Incontinence, Urge.
Browse Urinary Incontinence, Urge studies →Uro Medical Corporation is the lead sponsor of 4 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
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.
Also known as: Chronic Afferent Nerve Stimulation
Reduction in Urge Incontinence Episodes
Time frame: 90 days
Plan to share: Yes — Upon Study Completion
No publications or documents are linked to this record.
This study is terminated, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Uro Medical Corporation