Do you experience a sudden, uncontrollable urge to urinate? Can’t go too far from a bathroom?
At-home research study for Urge Urinary Incontinence
Purpose of this Study
The purpose of this research study is to evaluate the effectiveness of an experimental device (ELITONE-UUI) for treating urge urinary incontinence (UUI). Urge incontinence is when you leak after a sudden uncontrollable urge to urinate, often called “overactive bladder” (OAB). The device stimulates the pelvic floor muscles and surrounding structures to improve urinary incontinence.
If your leaks are caused by sneezing, coughing, laughing, exercising, or lifting heavy things, then you have “stress” incontinence, and this study is not for you. Please check out the original ELITONE which is FDA-cleared to treat stress incontinence and available without prescription.
The ELITONE-UUI Device
The ELITONE-UUI device (study device) is similar to the original ELITONE. Both devices are:
- Easy to Use: Treatment only takes 20 minutes a day and you can wear it while you go about your normal day. You simply Apply, Adjust, and Wear.
- External: You apply where you would put a pad, but adhered gently to your skin. Then get fully dressed and put the small controller in your pocket or clip it discreetly to your waistline.
Both devices work by using electrical stimulation to stimulate the nerves and muscles of the pelvic floor. The only difference between the study device and the original device is the muscle-stimulating signal that each device delivers. The study device outputs a signal specifically designed to treat urge incontinence.