Use of the Leva Incontinence System in Treating Bladder Incontinence.
| Status: | Completed |
|---|---|
| Conditions: | Urology, Urology |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 89 |
| Updated: | 12/14/2018 |
| Start Date: | April 10, 2017 |
| End Date: | October 20, 2017 |
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.
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.
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