At a glance
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Use of the Leva Incontinence System in Treating Bladder Incontinence.
In Brief
A clinical study evaluating Leva Incontinence System For Pelvic Floor Muscle strengthening for Stress Urinary Incontinence. Completed, enrolled 23 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
The leva device is placed vaginally for 2.5 minutes twice daily, and pelvic floor muscle exercises are performed based on guidance from data sent from the device to their mobile phone.