ELEC STIM
Electrical Field Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder - Version: 3.0 Dated 16 APR 2012.
Sponsor study identifier
interventional
130
0 countries
N/A
Study Start
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
October 2012
Actual (reported)Study Completion
January 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
October 31, 2011
Actual (reported)November 3, 2011
Actual (reported)October 2012
Actual (reported)January 2013
Actual (reported)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
One week after final treatment visit
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
First treatment through follow-up (one week after last treatment)
Treatment using electrical field stimulation of peripheral nerves
Control group using sham device to mimic sound and sensation of investigational device
Treatment with Electrical Field Stimulation Device
Use of the sham device
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Kenneth Peters, MD
Birmingham Urologic Associates
Scott MacDiarmid, MD
Alliance Urology Specialists
130 participants (actual enrollment reported by the registry).
First Submitted
October 31, 2011
First Posted
November 3, 2011
Study Start
October 2011
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Primary Completion
October 2012
Actual (reported)Study Completion
January 2013
Actual (reported)Last Updated
January 31, 2013
Record last verified: 2013-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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