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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
  Purpose

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.


Condition Intervention Phase
Urinary Incontinence, Urge
 Device: Electrical Field Stimulation Device
Device: Sham Nerve Stimulation Device
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Electrical Field Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder - Version: 3.0 Dated 16 APR 2012.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by EMKinetics, Inc:

Primary Outcome Measures:
  • 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


Enrollment: 130
Study Start Date: October 2011
Study Completion Date: January 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Investigational Device
Treatment using electrical field stimulation of peripheral nerves
 Device: Electrical Field Stimulation Device
Treatment with Electrical Field Stimulation Device
Sham Comparator: Sham Device
Control group using sham device to mimic sound and sensation of investigational device
 Device: Sham Nerve Stimulation Device
Use of the sham device

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Urinary Urge Incontinence
  • Urinary Frequency

Exclusion Criteria:

  • Primary complaint of Stress Incontinence
  • Neurogenic bladder
  • Overflow Incontinence
  • Functional Incontinence
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01464372

Sponsors and Collaborators
EMKinetics, Inc
Investigators
Principal Investigator: Kenneth Peters, MD Birmingham Urologic Associates
Principal Investigator: Scott MacDiarmid, MD Alliance Urology Specialists
  More Information

No publications provided

Responsible Party: EMKinetics, Inc
ClinicalTrials.gov Identifier: NCT01464372     History of Changes
Other Study ID Numbers: EMK0910
Study First Received: October 31, 2011
Last Updated: January 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by EMKinetics, Inc:
Urinary Incontinence, Urge
Peripheral Nerve Stimulation

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Incontinence, Urge
Urinary Bladder, Overactive
Urination Disorders
 Urologic Diseases
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on June 18, 2013