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

EMKinetics

Status and phase: Terminated; Phase 3

Conditions: Urinary Incontinence, Urge

Treatments: Device: Electrical Field Stimulation Device; Device: Sham Nerve Stimulation Device

Study type: Interventional

Funder types: Industry

Identifiers

NCT01464372

EMK0910

Details and patient eligibility

About

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.

Enrollment: 130 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Urinary Urge Incontinence
• Urinary Frequency

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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130 participants in 2 patient groups

Investigational Device

Experimental group

Description:

Treatment using electrical field stimulation of peripheral nerves

Treatment:

Device: Electrical Field Stimulation Device

Sham Device

Sham Comparator group

Description:

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

Treatment:

Device: Sham Nerve Stimulation Device