| 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) |
| Actual Enrollment : | 31 participants |
| Allocation: | N/A |
| Intervention Model: | Single Group Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence: a Pilot Study |
| Actual Study Start Date : | August 27, 2019 |
| Actual Primary Completion Date : | December 21, 2020 |
| Estimated Study Completion Date : | April 30, 2021 |
| Arm | Intervention/treatment |
|---|---|
|
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.
|
Device: leva
Vaginal device used for pelvic floor muscle exercises
|
| Ages Eligible for Study: | 18 Years to 89 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Subject must have a vagina |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| United States, Alabama | |
| University of Alabama | |
| Birmingham, Alabama, United States, 35233 | |
| Principal Investigator: | Holly Richter, MD PhD | University of Alabama at Birmingham |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | July 18, 2019 | ||||||
| First Posted Date ICMJE | July 19, 2019 | ||||||
| Last Update Posted Date | January 20, 2021 | ||||||
| Actual Study Start Date ICMJE | August 27, 2019 | ||||||
| Actual Primary Completion Date | December 21, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
St. Mark's Incontinence Score [ Time Frame: Baseline to 10 weeks ] Validated survey of fecal incontinence severity, score ranges from 0-24, Higher scores indicate more severe symptoms
|
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| Original Primary Outcome Measures ICMJE |
St. Mark's Incontinence Score [ Time Frame: Baseline to 10 weeks ] Validated survey of fecal incontinence severity, score ranges from 0-24
|
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| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
|
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| Original Secondary Outcome Measures ICMJE |
|
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence | ||||||
| Official Title ICMJE | Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence: a Pilot Study | ||||||
| Brief Summary | Pilot study to understand the impact of a digital health system, including a phone app and a vaginal probe to treat fecal incontinence in women | ||||||
| Detailed Description |
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 ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
||||||
| Condition ICMJE | Fecal Incontinence | ||||||
| Intervention ICMJE | Device: leva
Vaginal device used for pelvic floor muscle exercises
|
||||||
| Study Arms ICMJE | 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.
Intervention: Device: leva
|
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| Publications * | Not Provided | ||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||
| Actual Enrollment ICMJE |
31 | ||||||
| Original Estimated Enrollment ICMJE |
30 | ||||||
| Estimated Study Completion Date ICMJE | April 30, 2021 | ||||||
| Actual Primary Completion Date | December 21, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender ICMJE |
|
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| Ages ICMJE | 18 Years to 89 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | United States | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT04027335 | ||||||
| Other Study ID Numbers ICMJE | REN-17 | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
|
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| IPD Sharing Statement ICMJE |
|
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| Responsible Party | Renovia, Inc. | ||||||
| Study Sponsor ICMJE | Renovia, Inc. | ||||||
| Collaborators ICMJE | Not Provided | ||||||
| Investigators ICMJE |
|
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| PRS Account | Renovia, Inc. | ||||||
| Verification Date | January 2021 | ||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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