Pulsed Electromagnetic Stimulation for Treatment of Overactive Bladder

This study has been terminated.
(Major protocol changes needeed)
Sponsor:
Information provided by:
EMKinetics, Inc
ClinicalTrials.gov Identifier:
NCT00805779
First received: December 8, 2008
Last updated: June 6, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention
Urinary Bladder, Overactive
Device: MagPro R30

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pulsed Electromagnetic Stimulation for Treatment of Overactive Bladder

Resource links provided by NLM:


Further study details as provided by EMKinetics, Inc:

Primary Outcome Measures:
  • Improved urinary frequency and urgency after 12 weeks of treatment. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 4
Study Start Date: December 2008
Study Completion Date: April 2010
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  • 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).

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.
  • 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.
  • The patient has diagnosed peripheral neuropathy such as diabetes with peripheral nerve involvement.
  • The patient has concomitant medical conditions that would limit the success of the procedure or confound study results, including but not limited to patients with nerve damage, pacemakers or implantable defibrillators.
  • The patient is unable or unwilling to sign informed consent.
  • The patient is on pharmacologic treatment that could affect bladder function.
  • The patient has known moderate to severe ureteral reflux or hydronephrosis.
  • The patient has severe urethral stricture(s).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00805779

Locations
United States, California
UCSF Urology Faculty Practice
San Francisco, California, United States, 94122
Sponsors and Collaborators
EMKinetics, Inc
Investigators
Principal Investigator: Donna Y Deng, MD UCSF Department of Urology
  More Information

No publications provided

Responsible Party: Donna Deng, MD/Assistant Professor, UCSF
ClinicalTrials.gov Identifier: NCT00805779     History of Changes
Other Study ID Numbers: EMK1208
Study First Received: December 8, 2008
Last Updated: June 6, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by EMKinetics, Inc:
Overactive Bladder
Overactive Urinary Bladder
Bladder, Overactive
Overactive Detrusor
Detrusor, Overactive
Overactive Detrusor Function
Detrusor Function, Overactive

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 29, 2014