An interventional study of Leva and PFDx in Stress Urinary Incontinence and Mixed Urinary Incontinence, sponsored by Renovia, Inc.. Completed at 7 sites in United States. Open to female participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2020-10-08.
Sponsored by Renovia, Inc. · Not applicable, Interventional, and Treatment
A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence. Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone.
A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence.Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone. Leva subjects will perform guided pelvic floor muscle exercises for 2 1/2 minutes twice daily. Home kegel subjects will perform kegel exercises three times daily. Following 8-weeks of training, subjects will be permitted to continue the exercises or pursue additional therapies as indicated. Subjects randomized to the leva digital health system will be further randomized to receive automated reminders for the remainder of one year, or no additional reminders.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 77 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Renovia, Inc. is the lead sponsor of 4 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Subjects will undergo pelvic floor muscle training using the leva device (a vaginal probe) which provides immediate visual feedback via smartphone regarding the motion of pelvic floor muscles. Subjects will perform exercises 2 1/2 minutes twice daily for 8 weeks. At the beginning of the study, four weeks later, and eight weeks later subjects will undergo pelvic floor muscle testing using the PFDx device and surveys to document response to training. After eight weeks, subjects may pursue any additional treatments they wish, but may continue to use the device. They will be further randomized to receive reminder text messages or no messages over 10 months. Subjects will be asked to complete follow up surveys at 6- and 12-months.
Device: Leva · Device: PFDx
Subjects in this arm will perform pelvic floor muscle exercises (Kegels) for the treatment of stress or mixed urinary incontinence. Subjects will be asked to perform exercises three times daily for 8 weeks. At the beginning of the study, four weeks later, and eight weeks later, subjects will undergo pelvic floor muscle testing (using the PFDx device) and surveys to document response to training. After eight weeks, subjects may pursue any additional treatments they wish, but may continue to use the device.
Device: PFDx
Subjects randomized to Leva will use a vaginal probe containing motion-based sensors to direct the performance of pelvic muscle exercises.
All subjects (in both study arms) will be evaluated using a vaginally placed device that will evaluate pelvic floor motion to document change in pelvic floor muscle function resulting from pelvic floor muscle exercises.
PGI-I
PGI-I, Patient Global Impression of Improvement, is a five-point scale that ranges from "not at all" to "very much better."
Time frame: 8 weeks after randomization
UDI-6
Urogenital Distress Inventory is a six question validated questionnaire evaluating incontinence symptoms. It is scored from 0-100, with higher scores indicating more severely bothersome symptoms
Time frame: 8 weeks after randomization
3-day voiding diary
An objective evaluation of urinary incontinence
Time frame: 8 weeks after randomization
Adherence
Adherence to the exercise regimen will be evaluated
Time frame: 8 weeks, 6 months, 12 months
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Plan to share: No
This study is completed, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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Renovia, Inc.