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

• Sponsor: EMKinetics, Inc (Industry)
• Overall Status: Terminated
• CT.gov ID: NCT01464372
• Collaborator: (none)
• Enrollment: 130
• Arms: 2
• Duration (Months): 15

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Urinary Incontinence, Urge	Device: Electrical Field Stimulation Device; Device: Sham Nerve Stimulation Device	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Electrical Field Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder - Version: 3.0 Dated 16 APR 2012.
• Study Start Date: Oct 1, 2011
• Actual Primary Completion Date: Oct 1, 2012
• Actual Study Completion Date: Jan 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Investigational Device Treatment using electrical field stimulation of peripheral nerves	Device: Electrical Field Stimulation Device; Treatment with Electrical Field Stimulation Device
Sham Comparator: Sham Device Control group using sham device to mimic sound and sensation of investigational device	Device: Sham Nerve Stimulation Device; Use of the sham device

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Urinary Urge Incontinence

• Urinary Frequency

Exclusion Criteria:

• Primary complaint of Stress Incontinence

• Neurogenic bladder

• Overflow Incontinence

• Functional Incontinence

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• EMKinetics, Inc

Investigators

• Principal Investigator: Kenneth Peters, MD, Birmingham Urologic Associates
• Principal Investigator: Scott MacDiarmid, MD, Alliance Urology Specialists

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: EMKinetics, Inc
• ClinicalTrials.gov Identifier: NCT01464372
• Other Study ID Numbers: EMK0910
• First Posted: Nov 3, 2011
• Last Update Posted: Jan 31, 2013
• Last Verified: Jan 1, 2013

• Keywords provided by EMKinetics, Inc: Urinary Incontinence, Urge; Peripheral Nerve Stimulation
• Additional relevant MeSH terms: Urinary Incontinence; Enuresis; Urinary Bladder, Overactive; Urinary Incontinence, Urge

Study Results

No Results Posted as of Jan 31, 2013