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Electromagnetic Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder (ELEC STIM)

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
EMKinetics, Inc
ClinicalTrials.gov Identifier:
NCT01464372
First received: October 31, 2011
Last updated: January 30, 2013
Last verified: January 2013
History of Changes

October 31, 2011
January 30, 2013
October 2011
October 2012   (final data collection date for primary outcome measure)
  • Reduction of incontinence episodes from baseline to follow-up greater for device arm than sham arm [ Time Frame: One week after final treatment visit ] [ Designated as safety issue: No ]
    Significant increase in the percentage of patients reporting a reduction in number of incontinence episodes per day for the investigational device vs. sham
  • No Serious Adverse Events or Unanticipated Adverse Device Effects [ Time Frame: First treatment through follow-up (one week after last treatment) ] [ Designated as safety issue: Yes ]
    Freedom from Serious Adverse Events or Unanticipated Adverse Device Effects related to procedure and/or investigational device through follow-up
Same as current
Complete list of historical versions of study NCT01464372 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Electromagnetic Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder
Electrical Field Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder - Version: 3.0 Dated 16 APR 2012.

The purpose of this study is to collect data on the safety and efficacy of using an electrical field stimulation device, compared to a sham (placebo) device, to treat urinary urgency, urinary frequency and urge incontinence.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Urinary Incontinence, Urge
  • Device: Electrical Field Stimulation Device
    Treatment with Electrical Field Stimulation Device
  • Device: Sham Nerve Stimulation Device
    Use of the sham device
  • Experimental: Investigational Device
    Treatment using electrical field stimulation of peripheral nerves
    Intervention: Device: Electrical Field Stimulation Device
  • Sham Comparator: Sham Device
    Control group using sham device to mimic sound and sensation of investigational device
    Intervention: Device: Sham Nerve Stimulation Device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
130
January 2013
October 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Urinary Urge Incontinence
  • Urinary Frequency

Exclusion Criteria:

  • Primary complaint of Stress Incontinence
  • Neurogenic bladder
  • Overflow Incontinence
  • Functional Incontinence
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01464372
EMK0910
No
EMKinetics, Inc
EMKinetics, Inc
Not Provided
Principal Investigator: Kenneth Peters, MD Birmingham Urologic Associates
Principal Investigator: Scott MacDiarmid, MD Alliance Urology Specialists
EMKinetics, Inc
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP