Ignite Creation Date:
2024-05-06 @ 1:27 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04027335
Status:
UNKNOWN
Last Update Posted:
2021-01-20
First Post:
2019-07-18
Brief Title:
Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence
Sponsor:
Renovia Inc
Organization:
Renovia Inc
Study Overview
Official Title:
Use of the Leva Pelvic Digital Health System in Women With Fecal Incontinence a Pilot Study
Status:
UNKNOWN
Status Verified Date:
2021-01
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 inclusionexclusion 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None