Use of the Leva Incontinence System in Treating Bladder Incontinence.

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

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.

Primary Outcome Measures

Name	Time	Method
Symptoms of Urinary Incontinence at Baseline and at 6 Weeks	6 weeks	A validated, standardized questionnaire (the short form of the urogenital distress inventory, UDI-6) will be used to evaluate change in symptoms of urinary incontinence. Minimum score = 0, Maximum score = 100, lower scores indicate fewer symptoms.

Secondary Outcome Measures

Name	Time	Method
Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 6 Weeks.	6 weeks	Condition specific quality of life as it is affected by urinary incontinence will be assessed using the Incontinence Impact Questionnaire (IIQ-7). Minimum value 0, Maximum value 100, lower scores indicate improvement.
Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction)	6 weeks	Change in pelvic floor muscle performance will be evaluated using muscle performance testing performed using the leva device. Subjects were asked to lift and squeeze pelvic floor muscles for as long as possible. The length of time a subject can "hold" the lift was recorded
Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I)	At 6 weeks	Subject perception of improvement will be evaluated using the standardized survey Patient Global Impression of Improvement (PGI-I). Categories of improvement include: Very Much Better, Much Better, A Little Better, No Change, Worse(any degree).

Locations (1): New England Spine Center
🇺🇸
Cambridge, Massachusetts, United States
New England Spine Center
🇺🇸Cambridge, Massachusetts, United States