Use of the Leva Incontinence System in Treating Bladder Incontinence.
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|ClinicalTrials.gov Identifier: NCT03536923|
Recruitment Status : Completed
First Posted : May 25, 2018
Results First Posted : December 12, 2018
Last Update Posted : December 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stress Urinary Incontinence||Device: Leva Incontinence System For Pelvic Floor Muscle strengthening||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||23 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of the Leva Incontinence System in Treating Bladder Incontinence.|
|Actual Study Start Date :||April 10, 2017|
|Actual Primary Completion Date :||August 12, 2017|
|Actual Study Completion Date :||October 20, 2017|
Experimental: Leva Arm
Subjects will use the leva device twice daily to perform pelvic floor muscle exercises
Device: Leva Incontinence System For Pelvic Floor Muscle strengthening
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.
- Symptoms of Urinary Incontinence at Baseline and at 6 Weeks [ Time Frame: 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.
- Condition-specific Quality of Life Assessment (IIQ-7) at Baseline and 6 Weeks. [ Time Frame: 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.
- Number of Participants for Different Categories of Patient Global Impression of Improvement (PGI-I) [ Time Frame: 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).
- Pelvic Floor Muscle Performance (Mean Maximum Duration of Voluntary Pelvic Floor Muscle Contraction) [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03536923
|United States, Massachusetts|
|New England Spine Center|
|Cambridge, Massachusetts, United States, 02138|
|Principal Investigator:||Robert Rosenberg, MD||New England Spine Center|