Urinary Incontinence, Urge
Conditions
Keywords
Urinary Incontinence, Urge, Peripheral Nerve Stimulation
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.
Interventions
DEVICEElectrical Field Stimulation Device
Treatment with Electrical Field Stimulation Device
DEVICESham Nerve Stimulation Device
Use of the sham device
Sponsors
EMKinetics, Inc
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Urinary Urge Incontinence * Urinary Frequency
Exclusion criteria
* Primary complaint of Stress Incontinence * Neurogenic bladder * Overflow Incontinence * Functional Incontinence
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of incontinence episodes from baseline to follow-up greater for device arm than sham arm | 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 | 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 |
Outcome results
None listed