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

Primary Purpose

Urinary Incontinence, Urge

Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Electrical Field Stimulation Device
Sham Nerve Stimulation Device
Sponsored by
EMKinetics, Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Urinary Incontinence, Urge focused on measuring Urinary Incontinence, Urge, Peripheral Nerve Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Urinary Urge Incontinence
  • Urinary Frequency

Exclusion Criteria:

  • Primary complaint of Stress Incontinence
  • Neurogenic bladder
  • Overflow Incontinence
  • Functional Incontinence

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Sham Comparator

    Arm Label

    Investigational Device

    Sham Device

    Arm Description

    Treatment using electrical field stimulation of peripheral nerves

    Control group using sham device to mimic sound and sensation of investigational device

    Outcomes

    Primary Outcome Measures

    Reduction of incontinence episodes from baseline to follow-up greater for device arm than sham arm
    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
    Freedom from Serious Adverse Events or Unanticipated Adverse Device Effects related to procedure and/or investigational device through follow-up

    Secondary Outcome Measures

    Full Information

    First Posted
    October 31, 2011
    Last Updated
    January 30, 2013
    Sponsor
    EMKinetics, Inc
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01464372
    Brief Title
    Electromagnetic Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder
    Acronym
    ELEC STIM
    Official Title
    Electrical Field Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder - Version: 3.0 Dated 16 APR 2012.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2013
    Overall Recruitment Status
    Terminated
    Study Start Date
    October 2011 (undefined)
    Primary Completion Date
    October 2012 (Actual)
    Study Completion Date
    January 2013 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    EMKinetics, Inc

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Urinary Incontinence, Urge
    Keywords
    Urinary Incontinence, Urge, Peripheral Nerve Stimulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    130 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Investigational Device
    Arm Type
    Experimental
    Arm Description
    Treatment using electrical field stimulation of peripheral nerves
    Arm Title
    Sham Device
    Arm Type
    Sham Comparator
    Arm Description
    Control group using sham device to mimic sound and sensation of investigational device
    Intervention Type
    Device
    Intervention Name(s)
    Electrical Field Stimulation Device
    Intervention Description
    Treatment with Electrical Field Stimulation Device
    Intervention Type
    Device
    Intervention Name(s)
    Sham Nerve Stimulation Device
    Intervention Description
    Use of the sham device
    Primary Outcome Measure Information:
    Title
    Reduction of incontinence episodes from baseline to follow-up greater for device arm than sham arm
    Description
    Significant increase in the percentage of patients reporting a reduction in number of incontinence episodes per day for the investigational device vs. sham
    Time Frame
    One week after final treatment visit
    Title
    No Serious Adverse Events or Unanticipated Adverse Device Effects
    Description
    Freedom from Serious Adverse Events or Unanticipated Adverse Device Effects related to procedure and/or investigational device through follow-up
    Time Frame
    First treatment through follow-up (one week after last treatment)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Urinary Urge Incontinence Urinary Frequency Exclusion Criteria: Primary complaint of Stress Incontinence Neurogenic bladder Overflow Incontinence Functional Incontinence
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Kenneth Peters, MD
    Organizational Affiliation
    Birmingham Urologic Associates
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    Scott MacDiarmid, MD
    Organizational Affiliation
    Alliance Urology Specialists
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Electromagnetic Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder

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