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

Phase 3

Terminated

• Conditions: Urinary Incontinence, Urge

• Registration Number: NCT01464372
• Lead Sponsor: EMKinetics, Inc

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-10
• Study First Submitted: 2011-10-31
• Study First Submitted QC: 2011-11-01
• Study First Posted: 2011-11-03
• Primary Completion: 2012-10
• Status Verified: 2013-01
• Study Completion: 2013-01
• Last Update Submitted: 2013-01-30
• Last Update Posted: 2013-01-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 130

Inclusion Criteria

• Urinary Urge Incontinence
• Urinary Frequency

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Reduction of incontinence episodes from baseline to follow-up greater for device arm than sham arm	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
No Serious Adverse Events or Unanticipated Adverse Device Effects	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