Pulsed Electromagnetic Stimulation for Treatment of Overactive Bladder
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Urinary Bladder, Overactive
- Sponsor
- EMKinetics, Inc
- Enrollment
- 4
- Locations
- 1
- Primary Endpoint
- Improved urinary frequency and urgency after 12 weeks of treatment.
- Status
- Terminated
- Last Updated
- 14 years ago
Overview
Brief 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient is \> 18 years old.
- •The patient has ≥ 6 month history of documented overactive bladder.
- •The patient has failed other conventional therapy (i.e.- Kegel exercises, biofeedback methodology, etc.).
- •The patient is free of mechanical urethral obstruction as documented by cystoscopy or pressure flow criteria.
- •The patient demonstrates an understanding of neuromodulation therapy, its benefits, and its potential risks.
- •The patient is willing and able to keep accurate records of their voiding on the provided voiding diaries.
- •The patient is willing and able to comply with the Study Protocol.
- •The patient agrees to and is capable of answering a quality of life questionnaire.
- •The patient has normal functioning of the upper urinary tract.
- •The patient has an intact peripheral neurosensory system.
Exclusion Criteria
- •The patient is pregnant or intends to become pregnant during the course of the study. (Patients becoming pregnant during the course of the study will immediately be terminated from the study.) Warning: The effects of neuromodulation on a developing fetus are unknown
- •The patient has an active urinary tract infection.
- •The patient has abnormal cystoscopy, which is concerning for or indicative of malignancy.
- •The patient has a urinary fistula.
- •The patient has a bladder stone.
- •The patient has had ankle injury or surgery which results inability to stimulate the tibial nerve or discomfort in using the foot cradle
- •The patient has metal implant from surgery or a metallic foreign body in either leg below (distal to) the knee.
- •The patient has cochlear implants.
- •The patient has a hyperreflexic neurogenic bladder or urodynamically proven instability secondary to a known neurourologic cause (i.e.- stroke, Parkinson's, Multiple Sclerosis).
- •The patient has had four or more urinary tract infections in the past year.
Outcomes
Primary Outcomes
Improved urinary frequency and urgency after 12 weeks of treatment.
Time Frame: 12 weeks
Secondary Outcomes
- 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(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(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(12 weeks)