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
  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:


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
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: 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 Bladder, Overactive
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases

ClinicalTrials.gov processed this record on October 16, 2014