- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01464372
Electromagnetic Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder (ELEC STIM)
January 30, 2013 updated by: EMKinetics, Inc
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
130
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Urinary Urge Incontinence
- Urinary Frequency
Exclusion Criteria:
- Primary complaint of Stress Incontinence
- Neurogenic bladder
- Overflow Incontinence
- Functional Incontinence
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Investigational Device
Treatment using electrical field stimulation of peripheral nerves
|
Treatment with Electrical Field Stimulation Device
|
Sham Comparator: Sham Device
Control group using sham device to mimic sound and sensation of investigational device
|
Use of the sham device
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Reduction of incontinence episodes from baseline to follow-up greater for device arm than sham arm
Time Frame: One week after final treatment visit
|
Significant increase in the percentage of patients reporting a reduction in number of incontinence episodes per day for the investigational device vs. sham
|
One week after final treatment visit
|
No Serious Adverse Events or Unanticipated Adverse Device Effects
Time Frame: First treatment through follow-up (one week after last treatment)
|
Freedom from Serious Adverse Events or Unanticipated Adverse Device Effects related to procedure and/or investigational device through follow-up
|
First treatment through follow-up (one week after last treatment)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Scott MacDiarmid, MD, Alliance Urology Specialists
- Principal Investigator: Kenneth Peters, MD, Birmingham Urologic Associates
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2011
Primary Completion (Actual)
October 1, 2012
Study Completion (Actual)
January 1, 2013
Study Registration Dates
First Submitted
October 31, 2011
First Submitted That Met QC Criteria
November 1, 2011
First Posted (Estimate)
November 3, 2011
Study Record Updates
Last Update Posted (Estimate)
January 31, 2013
Last Update Submitted That Met QC Criteria
January 30, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EMK0910
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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