Tuesday, March 2, 2010

Urgent PC Neuromodulation System Stimulates Leg Nerve, Aims to Quell Overactive Bladder

Filed under: Neurology , Ob/Gyn , Urology

Clinicians recently concluded a multicenter study of the Urgent PC Neuromodulation System for urinary urgency, urinary frequency and urge incontinence. The device, made by Uroplasty of Minnetonka, MN, is a neurostimulator that acts on the tibial nerve through the ankle via which it sends a signal to the sacral nerve plexus that regulates urinary function. The advantage of the system lies in its indirect, minimally invasive action.

Here's from the study abstract's results and conclusions:

The 13-week subject global response assessment for overall bladder symptoms demonstrated that percutaneous tibial nerve stimulation subjects achieved statistically significant improvement in bladder symptoms with 54.5% reporting moderately or markedly improved responses compared to 20.9% of sham subjects from baseline (p <0.001). All individual global response assessment subset symptom components demonstrated statistically significant improvement from baseline to 13 weeks for percutaneous tibial nerve stimulation compared to sham. Voiding diary parameters after 12 weeks of therapy showed percutaneous tibial nerve stimulation subjects had statistically significant improvements in frequency, nighttime voids, voids with moderate to severe urgency and urinary urge incontinence episodes compared to sham. No serious device related adverse events or malfunctions were reported.

This pivotal multicenter, double-blind, randomized, sham controlled trial provides level I evidence that percutaneous tibial nerve stimulation therapy is safe and effective in treating overactive bladder symptoms. The compelling efficacy of percutaneous tibial nerve stimulation demonstrated in this trial is consistent with other recently published reports and supports the use of peripheral neuromodulation therapy for overactive bladder.

Abstract in The Journal of Urology: Randomized Trial of Percutaneous Tibial Nerve Stimulation Versus Sham Efficacy in the Treatment of Overactive Bladder Syndrome: Results From the SUmiT Trial

Press release: SUmiT TRIAL RESULTS CLEARLY DEMONSTRATE THERAPEUTIC EFFECT OF PERCUTANEOUS TIBIAL NERVE STIMULATION...

Product page: Urgent® PC ...

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