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

Urinary Incontinence, Urge Clinical Trial

— ELEC STIM  

Official title:

Electrical Field Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder - Version: 3.0 Dated 16 APR 2012.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01464372
• Other study ID #: EMK0910
• Status: Terminated
• Phase: Phase 3
• First received: October 31, 2011
• Last updated: January 30, 2013
• Start date: October 2011
• Est. completion date: January 2013

Study information

• Verified date: January 2013
• Source: EMKinetics, Inc
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 130
• Est. completion date: January 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Urinary Urge Incontinence

• Urinary Frequency

Exclusion Criteria:

• Primary complaint of Stress Incontinence

• Neurogenic bladder

• Overflow Incontinence

• Functional Incontinence

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Bladder, Overactive
• Urinary Incontinence
• Urinary Incontinence, Urge

Intervention

Device:
• Electrical Field Stimulation Device
Treatment with Electrical Field Stimulation Device
• Sham Nerve Stimulation Device
Use of the sham device

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMKinetics, Inc

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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)	Yes