Medical device company Uroplasty has presented positive results from a nine-year follow-up study of a subcutaneous tibial nerve stimulator for treating overactive bladder (OAB) syndrome.
The FDA-approved minimally invasive stimulator, Urgent PC neuromodulation system, is designed to stimulate the tibial nerve passing through the popliteal fossa, which is responsible for controlling symptoms of urinary urgency, frequency and incontinence.
The pilot study included seven patients, who were implanted in 2003, to assess the safety and durability of the device.
The results demonstrated that three of seven patients have continued use of the device, with improvement to their quality of life and reduction in sustained OAB symptoms.
After participating in the follow-up study, another patient has successfully restarted using the device, according to the company.
Radboud University Nijmegen Medical Centre urology department spokesperson, professor John Heesakkers, said the results demonstrated that the tibial nerve stimulator is very safe.
Uroplasty CEO and president David Kaysen said that a low profile nerve stimulator that appears to have few adverse events allows patients to continue their therapy at home.
"Based upon these promising results, Uroplasty has begun a research and development initiative to bring a version of this implantable tibial nerve neuromodulation device to the market," Kaysen said.
"As we announced previously, we plan to first acquire a CE mark and commercialise the device in Europe, before starting the regulatory process in the United States.
"Patients will receive their initial therapy with the Uroplasty Urgent PC Neuromodulation System before being offered the option of an implant."