Pulsed Electromagnetic Stimulation for Treatment of Overactive Bladder

NCT00805779 | Terminated

• 1 other identifier: EMK1208
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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

Conditions

Urinary Bladder, Overactive

Keywords

Overactive Bladder; Overactive Urinary Bladder; Bladder, Overactive; Overactive Detrusor; Detrusor, Overactive; Overactive Detrusor Function; Detrusor Function, Overactive

Outcome Measures

Primary Outcomes (1)

• Improved urinary frequency and urgency after 12 weeks of treatment.

  12 weeks

Secondary Outcomes (3)

• 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

Interventions

MagPro R30 DEVICE

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• If the patient is/was on pharmacologic treatment for urgency/frequency syndrome, a 10-day washout period prior to treatment must be completed.
• The patient has sufficient outlet resistance at the urinary sphincter (i.e.- the patient does not have intrinsic sphincter deficiency).

You may not qualify if:

• 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.
• The patient has a chronic disease or diminished mental capacity that, in the Principal Investigator's judgement, would impair their ability to successfully understand and comply with the protocol.
• The patient has a history of gross hematuria or glycosuria within the last year.
• The patient has chronic constipation (less than two (2) bowel movements per week).
• The patient has significant pathology that would compromise sphincter competency.
• The patient has uncontrolled diabetes.

Sponsors & Collaborators

• EMKinetics, Inc: lead

Study Sites (1)

UCSF Urology Faculty Practice

San Francisco, California, 94122, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Donna Y Deng, MD

  UCSF Department of Urology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: December 8, 2008
• First Posted: December 10, 2008
• Study Start: December 1, 2008
• Primary Completion: December 1, 2009
• Study Completion: April 1, 2010
• Last Updated: June 8, 2011

Record last verified: 2011-06

Locations

US (1)