The Urgent PC System (Uroplasty, Inc., Minnetonka, MN) appears to significantly improve urinary symptoms associated with overactive bladder, according to results of a recent multicenter trial that compared the treatment with a sham procedure.

The minimally invasive, percutaneous tibial nerve stimulation (PTNS) device is designed for office-based treatment of urinary urgency, urinary frequency, and urge incontinence symptoms associated with overactive bladder.

The SUmiT Trial was a 220-patient randomized, double-blind study. Patients and investigators reported statistically significant OAB symptom improvement compared with a validated sham procedure.

Highlights from the study, which was published online in the Journal of Urology (Feb. 19, 2010), include the following:

• 58.3% of PTNS patients considered their overall urinary symptoms moderately or markedly improved compared with 21.9% of sham patients.
• Statistically significant changes for PTNS patients included reduction in voiding frequency, urinary urge incontinence episodes, nighttime voids, urgency episodes and voids with moderate to severe volume, in addition to improvement in voiding volume and quality of life measures.
• Neither group reported any serious adverse events.

"This important study is the first publication that demonstrates the effectiveness of PTNS compared to a validated sham procedure," said lead author Kenneth Peters, MD, of Beaumont Hospital, Royal Oak, MI. "PTNS is a viable OAB treatment and its efficacy is irrefutably demonstrated. It is rare that a medical device is put through such rigorous testing, first comparing it to standard drug therapy as recently done in the OrBIT [Overactive Bladder Innovative Therapy] study and now demonstrating superiority to a sham procedure."

The study was supported by Uroplasty.