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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4
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.
UCSF Urology Faculty Practice
San Francisco, California, United States
Improved urinary frequency and urgency after 12 weeks of treatment.
Time frame: 12 weeks
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
Time frame: 12 weeks
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
Time frame: 12 weeks
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
Time frame: 12 weeks
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