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

NCT ID: NCT01464372

Last Updated: 2013-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

130 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2013-01-31

Brief Summary

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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

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Conditions

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Urinary Incontinence, Urge

Keywords

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Urinary Incontinence, Urge Peripheral Nerve Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Investigational Device

Treatment using electrical field stimulation of peripheral nerves

Group Type EXPERIMENTAL

Electrical Field Stimulation Device

Intervention Type DEVICE

Treatment with Electrical Field Stimulation Device

Sham Device

Control group using sham device to mimic sound and sensation of investigational device

Group Type SHAM_COMPARATOR

Sham Nerve Stimulation Device

Intervention Type DEVICE

Use of the sham device

Interventions

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Electrical Field Stimulation Device

Treatment with Electrical Field Stimulation Device

Intervention Type DEVICE

Sham Nerve Stimulation Device

Use of the sham device

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Urinary Urge Incontinence
* Urinary Frequency

Exclusion Criteria

* Primary complaint of Stress Incontinence
* Neurogenic bladder
* Overflow Incontinence
* Functional Incontinence
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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EMKinetics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kenneth Peters, MD

Role: PRINCIPAL_INVESTIGATOR

Birmingham Urologic Associates

Scott MacDiarmid, MD

Role: PRINCIPAL_INVESTIGATOR

Alliance Urology Specialists

Other Identifiers

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EMK0910

Identifier Type: -

Identifier Source: org_study_id