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news.Uroplasty, a medical device company, has completed patient enrollment in the randomized, controlled multicenter clinical study of its Urgent PC neuromodulation system for the treatment of overactive bladder symptoms of urinary urgency, urge incontinence and frequency of urinary voids.
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A total of 214 patients have enrolled two months ahead of schedule in the clinical study of Urgent PC versus sham effectiveness in treatment of overactive bladder symptoms (SUmiT) at 22 centers throughout the US.
The study is designed to directly compare the effectiveness of percutaneous tibial nerve stimulation using Urgent PC to a non-active sham. Uroplasty is undertaking this study primarily to expand and support third-party reimbursement coverage in the US.
The study will evaluate reductions in urinary urgency, urge incontinence and frequency of urinary voids, as well as patient quality of life measures, and is expected to be completed by early fall of 2009.
David Kaysen, president and CEO of Uroplasty, said: Our goal with the SUmiT study is to expand and support third-party reimbursement coverage for the Urgent PC procedure in the US and we are extremely pleased with the early completion of patient enrollment. Assuming the results of the study are positive, we anticipate applying to the American Medical Association for a specific ‘listed’ CPT reimbursement code for Urgent PC treatments.