NCT00805779

Pulsed Electromagnetic Stimulation for Treatment of Overactive Bladder

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: EMKinetics, Inc · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To assess the initial safety and clinical feasibility of neuromodulation therapy in treating patients with documented overactive bladder. The specific aim is improved urinary frequency and urgency after 12 weeks of treatment

Detailed description

Twenty to Forty patients with documented overactive bladder will receive 30 minutes of treatment one day a week for 12 weeks. Treatment will consist of stimulating the posterior tibial nerve in the area of the ankle with a pulsed electromagnetic field. Study treatments will be administered by a commercially available MagPro R30, with a cooled figure eight coil, and a surface electrode placed over the afferent pathway of the sacral nerve. The specific aim is improved urinary frequency and urgency after 12 weeks of treatment. Secondary goals. * To estimate the extent to which the device will decrease the number of episodes of involuntary urine loss due to frequency/urgency in comparison to historical controls. * To evaluate the potential of the device for improving patient quality of life as measured by a clinically validated scale, such as the Incontinence Quality of Life Instrument (I-QOL) or equivalent * To periodically employ a micturition diary to record variables such as day/night urgency/frequency episodes, number of voids per day, severity of leaks, number of absorbent products used per day, etc.

Conditions

• Urinary Bladder, Overactive

Interventions

Type	Name	Description
DEVICE	MagPro R30	Study treatments will be administered by a commercially available MagPro R30, with a cooled figure eight coil. The figure eight coil is placed directly over the posterior tibial nerve and the MagPro R30 will be activated. The coil will stimulate the posterior tibial nerve at 20 pulses per second for a 30 minute session.

Timeline

• Start date: 2008-12-01
• Primary completion: 2009-12-01
• Completion: 2010-04-01
• First posted: 2008-12-10
• Last updated: 2011-06-08

Locations

1 site across 1 country: United States