Urinary Bladder, Overactive Clinical Trial
Official title:
Pulsed Electromagnetic Stimulation for Treatment of Overactive Bladder
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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