The Urgent PC Neuromodulation System is a proprietary minimally invasive, percutaneous tibial nerve stimulation (PTNS) device for office-based treatment of urinary urgency, urinary frequency and urge incontinence, symptoms often associated with overactive bladder (OAB).
This placebo-controlled, randomized, double-blind study was powered to show effectiveness with a sample size of 35 female patients. Patients and investigators reported statistically significant OAB symptom improvement in the PTNS group compared to the placebo group.
Highlights from the study include:
•71% of the PTNS group reported a 50% or greater reduction in incontinence episodes, compared to a 0% reduction in the placebo group
•Statistically significant decrease in incontinence episodes in the PTNS group from 4.1 to 1.8 (p<0.001), compared to the placebo group which did not show a significant decrease
•Statistically significant decrease in voiding frequency in the PTNS group from 13.6 to 9.5 (p<0.001), compared to the placebo group which did not show a significant decrease
•Statistically significant increase in voided volume in the PTNS group from 150.5 cc to 186.5 cc (p<0.001), compared to the placebo group which did not show a significant increase
•After the third treatment, subjects were unable to identify whether they were receiving the PTNS therapy or the placebo, confirming that the placebo effectively mimicked the active treatment
•Neither group reported any serious adverse events
"We are very pleased with the outcome of this study and we believe it shows PTNS to be an effective treatment option for detrusor overactivity incontinence, and that a placebo effect seems to be negligible in this patient population," said Dr. Enrico Finazzi-Agro, lead investigator, from the Department of Urology, University of Rome "Tor Vergata." "Our study results confirm those of Dr. Peters et al from the recently published SUMiT study showing that PTNS is effective and safe for treating patients with detrusor overactivity as seen in overactive bladder."
Dr. Ragi Doggweiler of the University of Tennessee Medical Center, provided editorial comment in the same edition titled: Will Posterior Tibial Nerve Stimulation Replace Sacral Nerve Root Stimulation as the Salvage Management of Drug Resistant Urinary Urge Incontinence?
"It is exciting to see that more functional approaches are being developed to treat voiding dysfunction," Dr. Doggweiler said. "When reviewing the options available today, it makes sense to consider PTNS as a replacement for pharmacotherapy in patients on multiple medications. In addition, given the economic implications in today's healthcare environment, PTNS may be considered as the first choice for neuromodulation over the more expensive and invasive sacral nerve stimulation," added Dr. Doggweiler.
"We believe these results mirror those already reported from the SUMiT study," said Dave Kaysen, President and Chief Executive Officer of Uroplasty, Inc. "Placebo controlled studies are standard in the pharmaceutical industry but rarely seen with medical devices. This study further reinforces the clinical efficacy of PTNS in the treatment of OAB and provides clinicians with another effective therapy for this often difficult-to-treat patient population," added Mr. Kaysen.