Posterior Tibial Nerve Stimulation vs. Sham

PHASE3CompletedINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

September 30, 2007

Study Completion Date

September 30, 2007

Conditions
Overactive Bladder
Interventions
DEVICE

Posterior Tibial Nerve Device

The PTNS device (Urgent® PC) is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve (PTNS). It is a combination of a stimulator and a lead set. The stimulator is a battery powered, external pulse generator and is designed, constructed, and manufactured for multiple use in conjunction with the lead set. The lead set (comprised of the lead wires, needle electrode, and alcohol pad) transfers the electrical current from the stimulator to the tibial nerve via the needle electrode. The tibial nerve travels up the leg to the sacral nerve plexus which regulates the bladder and pelvic floor function.

DEVICE

Sham

This 2- piece needle, comprised of a needle handle and blunt-tip shaft feels like a slight prick when touched to the skin. However the shaft retracts as it appears to enter the skin but the skin is not punctured. The Streitberger needle specifically activates the dorsolateral prefrontal cortex, which is associated with the placebo effect.

Trial Locations (1)

48073

William Beaumont Hospital, Royal Oak

All Listed Sponsors
lead

William Beaumont Hospitals

OTHER

NCT00534521 - Posterior Tibial Nerve Stimulation vs. Sham | Biotech Hunter | Biotech Hunter