Electrical Field Stimulation for the Treatment of Urge Urinary Incontinence and Overactive Bladder - Version: 3.0 Dated 16 APR 2012.
Trial Snapshot
- Phase
- Phase 3
- Status
- Terminated
- Sponsor
- EMKinetics, Inc
- Enrollment
- 130
- Primary Endpoint
- Reduction of incontinence episodes from baseline to follow-up greater for device arm than sham arm
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Arms & Interventions
Investigational Device
Treatment using electrical field stimulation of peripheral nerves
Intervention: Electrical Field Stimulation Device (Device)
Sham Device
Control group using sham device to mimic sound and sensation of investigational device
Intervention: Sham Nerve Stimulation Device (Device)
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
No secondary outcomes reported