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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
130
Treatment with Electrical Field Stimulation Device
Use of the sham device
Reduction of incontinence episodes from baseline to follow-up greater for device arm than sham arm
Significant increase in the percentage of patients reporting a reduction in number of incontinence episodes per day for the investigational device vs. sham
Time frame: One week after final treatment visit
No Serious Adverse Events or Unanticipated Adverse Device Effects
Freedom from Serious Adverse Events or Unanticipated Adverse Device Effects related to procedure and/or investigational device through follow-up
Time frame: First treatment through follow-up (one week after last treatment)
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