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

Phase 3

Terminated

• Conditions: Urinary Incontinence, Urge
• Interventions: Device: Electrical Field Stimulation Device; Device: Sham Nerve Stimulation Device

• 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

Arm && Interventions

Group	Intervention	Description
Investigational Device	Electrical Field Stimulation Device	Treatment using electrical field stimulation of peripheral nerves
Sham Device	Sham Nerve Stimulation Device	Control group using sham device to mimic sound and sensation of investigational device

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