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Urinary Bladder, OveractiveNCT00805779

Pulsed Electromagnetic Stimulation for Treatment of Overactive Bladder

A study testing MagPro R30 in people with Urinary Bladder, Overactive, run by EMKinetics, Inc at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Urinary Bladder, Overactive
What is being tested?
MagPro R30
Type of treatment
Medical device
How many people
4 participants
Where
1 siteUnited States
Study dates
Dec 2008to Apr 2010
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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).

Who cannot join

  • 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
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  • 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).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • UCSF Urology Faculty Practice

    San Francisco, California, 94122

Other trials in United States

About this study

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

Read the 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.
Being tested
MagPro R30
Keywords
Overactive Bladder, Overactive Urinary Bladder, Bladder, Overactive, Overactive Detrusor, Detrusor, Overactive, Overactive Detrusor Function, Detrusor Function, Overactive
Medical subject headings
Urinary Bladder, Overactive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MagPro R30Device

    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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12 weeks

Secondary outcomes (3)

  1. 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

    Measured: 12 weeks

  2. 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

    Measured: 12 weeks

  3. 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

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Dec 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionDec 2009
  4. Study completionApr 2010

Why it stopped: Major protocol changes needeed

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00805779
Sponsor's protocol ID
EMK1208
Status last verified
Jun 2011
First submitted
8 Dec 2008
Last updated
8 Jun 2011
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing MagPro R30 in people with Urinary Bladder, Overactive, run by EMKinetics, Inc at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: Major protocol changes needeed). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Improved urinary frequency and urgency after 12 weeks of treatment. (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00805779.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2011.

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