Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence: a Pilot Study
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04027335|
Recruitment Status : Not yet recruiting
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
|Condition or disease||Intervention/treatment||Phase|
|Fecal Incontinence||Device: leva||Not Applicable|
Subjects meeting inclusion/exclusion criteria at screening will complete training in behavioral therapy for the treatment of fecal incontinence and training in the use of the Leva pelvic digital health system.
Subjects will then participate in 10 weeks of at home pelvic floor muscle training using the leva device twice daily for 2 ½ minutes of training.
Adherence to the training protocol will be observed digitally, and subjects will receive phone calls every other week from research assistants reviewing their adherence.
Subjects are expected to participate in at least 80% of the weekly exercises (11 weekly).
Subjects will return to clinic at 5- and 10-weeks during the study to complete questionnaires. At 5-weeks, subjects will review the use of the device with the study assistant, who will answer any questions and repeat training if the subject desires additional training.
Following 10 weeks of training, subjects will be free to pursue any additional therapies, but will also retain the leva device and may continue its use if desired. Adherence will be monitored for one additional year, with follow up surveys to be completed by mail or digitally at 6- and 12-months
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence: a Pilot Study|
|Estimated Study Start Date :||August 1, 2019|
|Estimated Primary Completion Date :||February 1, 2020|
|Estimated Study Completion Date :||April 11, 2020|
Experimental: Leva Arm
Subjects will undergo training in the use of a vaginal device and its associated app, to be used twice daily to perform pelvic floor muscle exercises guided by the device/app for 10 weeks.
Vaginal device used for pelvic floor muscle exercises
- St. Mark's Incontinence Score [ Time Frame: Baseline to 10 weeks ]Validated survey of fecal incontinence severity, score ranges from 0-24
- Change in Fecal incontinence episodes [ Time Frame: Baseline to 10 weeks ]Change in the number of fecal incontinence episodes (%) recorded on a two week diary of fecal incontinence episodes
- Fecal Incontinence Quality of Life Score [ Time Frame: Change in score from baseline to 10 weeks ]Validated Survey evaluates four areas- coping, depression, lifestyle and embarrassment
- Cumulative adherence correlation with change in St. Mark's score [ Time Frame: baseline to 10 weeks ]Adherence as a percentage of all expected exercise sessions (140) correlation with change in St Mark's Incontinence Score (1-24)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04027335
|Contact: Samantha J Pulliam, M.D.||866-735-8424 ext email@example.com|
|United States, Alabama|
|University of Alabama||Not yet recruiting|
|Birmingham, Alabama, United States, 35233|
|Contact: Holly Richter, MD PhD 205-934-1704 firstname.lastname@example.org|
|Principal Investigator:||Holly Richter, MD PhD||University of Alabama at Birmingham|