Use of the Leva Incontinence System in Treating Bladder Incontinence.

Exclusion Criteria

• •Absence of a vagina.
• •Positive drug or alcohol test at the screening visit.
• •Post-menopausal defined as absence of a period for over 12 months.
• •Pregnancy or being less than 12 months post-partum.
• •Greater than three vaginal deliveries or prior operative delivery (e.g. use of vacuum, forceps or abdominal pressure).
• •Symptoms of stage II or greater pelvic organ prolapse.
• •BMI \>31 kg/m2.
• •Diagnosis of any neurological disorder.
• •Prior lower back or pelvic surgery, including prior surgery for stress urinary incontinence (SUI).
• •Prior pelvic radiation.
• •Current or recurrent vaginal infections (\>three per year).
• •Painful bladder syndrome, active or chronic pelvic pain.
• •Concurrent Pelvic Floor Muscle Exercises (PFME) under a supervised therapeutic plan of care.
• •Previous supervised pelvic floor muscles rehabilitation in the past 12 months for the treatment for urinary incontinence or any other pelvic floor disorder.
• •Currently taking medication to treat incontinence.
• •Impaired cognitive function.
• •Unable to tolerate use of the leva device.