Use of the Leva Incontinence System in Treating Bladder Incontinence.

Use of the Leva Incontinence System in Treating Bladder Incontinence.

This open-label proof-of-concept study is designed to evaluate the impact of the leva digital incontinence system on the treatment of stress and mixed urinary incontinence in women over a six week period. Subjects will participate in a 2.5 minute exercise program twice daily (performed at a clinic with therapist assistance 5x weekly, and at home once daily on weekdays and twice daily on weekends. Validated surveys (UDI-6, IIQ-7 and PGI-I) will be used to evaluate symptom relief. A battery of pelvic floor muscle exercises will be performed weekly to evaluate progress in muscle strengthening.

Inclusion Criteria

• Subjects must be female.
• Subjects must be capable of giving informed consent.
• Subjects should be at least 18 years of age and less than 89 years of age
• Subjects must have a diagnosis of or symptoms of predominant mild to moderate urinary incontinence based on the results of the completed urinary incontinence surveys.

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.