massagedoula
11-12-2005, 07:27 AM
Neuromodulation Device (Urgent PC) for the Treatment of Overactive Bladder
The FDA approved in October a percutaneous tibial nerve stimulation system (Urgent PC, made by Uroplasty, Inc.) for the minimally invasive treatment of overactive bladder symptoms such as urinary urgency, urinary frequency, and urge incontinence.
The nonsurgical system is designed for use in an office setting and consists of a small 34-G needle electrode, surface electrode, lead wire, and handheld low-voltage (9 volts) electrical generator with adjustable pulse intensity (0-10 mA), a fixed pulse width of 200 µs, and a frequency of 20 Hz.
The percutaneous needle is inserted approximately two inches cephaled to the medial malleous and attached to the lead wire and electrode. The stimulator is then turned on and the amplitude slowly increased until the patient's large toe begins to curl, the toes fan out, or the entire foot extends to indicate proximity to the nerve bundle.
The amplitude is then reduced slightly and treatment continues for 30 minutes, during which electrical impulses are transmitted to the sacral nerve plexus via the tibial nerve. Treatments are performed on a once-weekly basis.
According to a company news release, significant reductions in urge frequency and intensity have been observed after approximately 12 weeks; no significant adverse effects were reported.
Once symptoms have abated, treatment frequency may be reduced. If symptoms reappear or increase in severity, the last previously effective treatment schedule should be reinstated.
The neuromodulation system was previously approved by the European Commission in 2003.
The FDA approved in October a percutaneous tibial nerve stimulation system (Urgent PC, made by Uroplasty, Inc.) for the minimally invasive treatment of overactive bladder symptoms such as urinary urgency, urinary frequency, and urge incontinence.
The nonsurgical system is designed for use in an office setting and consists of a small 34-G needle electrode, surface electrode, lead wire, and handheld low-voltage (9 volts) electrical generator with adjustable pulse intensity (0-10 mA), a fixed pulse width of 200 µs, and a frequency of 20 Hz.
The percutaneous needle is inserted approximately two inches cephaled to the medial malleous and attached to the lead wire and electrode. The stimulator is then turned on and the amplitude slowly increased until the patient's large toe begins to curl, the toes fan out, or the entire foot extends to indicate proximity to the nerve bundle.
The amplitude is then reduced slightly and treatment continues for 30 minutes, during which electrical impulses are transmitted to the sacral nerve plexus via the tibial nerve. Treatments are performed on a once-weekly basis.
According to a company news release, significant reductions in urge frequency and intensity have been observed after approximately 12 weeks; no significant adverse effects were reported.
Once symptoms have abated, treatment frequency may be reduced. If symptoms reappear or increase in severity, the last previously effective treatment schedule should be reinstated.
The neuromodulation system was previously approved by the European Commission in 2003.