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

January 30, 2013 updated by: EMKinetics, Inc

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

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Urinary Urge Incontinence
  • Urinary Frequency

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of incontinence episodes from baseline to follow-up greater for device arm than sham arm
Time Frame: 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
One week after final treatment visit
No Serious Adverse Events or Unanticipated Adverse Device Effects
Time Frame: 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
First treatment through follow-up (one week after last treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

October 31, 2011

First Submitted That Met QC Criteria

November 1, 2011

First Posted (Estimate)

November 3, 2011

Study Record Updates

Last Update Posted (Estimate)

January 31, 2013

Last Update Submitted That Met QC Criteria

January 30, 2013

Last Verified

January 1, 2013

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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