Uroplasty Initiates Enrollment for Overactive Bladder Trial
Uroplasty, a medical device company, has announced the enrollment of the first patients in a new randomized, controlled multicenter clinical study of its FDA cleared Urgent PC neuromodulation system for the treatment of overactive bladder.
The study is designed to directly compare the effectiveness of Urgent PC treatment to non-active treatment. Uroplasty is undertaking this study primarily to support third-party reimbursement coverage. The study will evaluate reductions in urinary urgency, urge incontinence and frequency of urinary voids, as well as patient quality of life measures.
The Urgent PC system is minimally invasive, office-based, nonsurgical, percutaneous tibial nerve stimulation (PTNS) device that treats these symptoms. The company believes physicians, patients and many third party payers are embracing the Urgent PC therapy because this low cost, non-surgical, non-drug treatment alternative is clinically effective.
This study, expected to be completed by early fall of 2009, is to take place at approximately 20 urology and urogynecology centers across the US, with total enrollment of 214 patients.
Kenneth Peters, principal investigator of this study, said: “I am pleased to commence a well designed, randomized controlled trial to provide the medical community with additional scientific data regarding the use of PTNS. When completed, this study will provide a valuable complement to previous studies comparing the effectiveness of PTNS to active controls such as pharmaceuticals.”