Ignite Creation Date:
2024-05-06 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 12:46 PM
Study NCT ID:
NCT03536923
Status:
COMPLETED
Last Update Posted:
2018-12-12
First Post:
2018-05-13
Brief Title:
Use of the Leva Incontinence System in Treating Bladder Incontinence
Sponsor:
Renovia Inc
Organization:
Renovia Inc
Study Overview
Official Title:
Use of the Leva Incontinence System in Treating Bladder Incontinence
Status:
COMPLETED
Status Verified Date:
2018-12
Last Known Status:
None
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:
This open-label proof-of-concept study is designed to evaluate the impact of the leva digital incontinence system on the treatment of stress and mixed urinary incontinence in women over a six week period Subjects will participate in a 25 minute exercise program twice daily performed at a clinic with therapist assistance 5x weekly and at home once daily on weekdays and twice daily on weekends Validated surveys UDI-6 IIQ-7 and PGI-I will be used to evaluate symptom relief A battery of pelvic floor muscle exercises will be performed weekly to evaluate progress in muscle strengthening
Detailed Description:
None
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