Results of implanted tibial nerve stimulator long-term study

MINNETONKA, MN – Uroplasty, Inc. has recently announced that the results of a long-term clinical pilot study using an implantable tibial nerve stimulation device will be presented at the Annual Meeting of the International Continence Society (ICS), October 15-19, 2012 in Beijing.

The study reviewed the long term safety and durability of the device in seven patients who were implanted in 2003. Uroplasty acquired rights to the device when it acquired rights to its Urgent PC product.

Results showed that 3 out of the 7 patients in the study have safely continued to use the device regularly over 9 years, with sustained overactive bladder (OAB) symptom improvement and continued improvement in their quality of life. Another patient has successfully restarted using the device after participating in this follow-up study.  No displacements or defects of the implants were demonstrated on X-ray, while all patients described the device as easy to handle.

"After nine years of clinical experience with an implanted subcutaneous tibial nerve stimulator, we have demonstrated that it is a durable therapy for treating OAB patients," said Professor John Heesakkers , Department of Urology, Radboud University Nijmegen Medical Center, Nijmegen, The Netherlands. "We are pleased to report that many patients have sustained their OAB symptom improvement. Moreover we demonstrated that the device is very safe."

David Kaysen, Uroplasty CEO and president, said there are several key advantages to an implantable tibial nerve stimulator. "This device allows the patients to continue therapy at home according to the schedule that works best for them using a very low profile device that appears to have few if any adverse events,” he said.