Ignite Creation Date:
2024-05-06 @ 11:55 AM
Last Modification Date:
2024-10-26 @ 12:51 PM
Study NCT ID:
NCT03632447
Status:
COMPLETED
Last Update Posted:
2020-10-08
First Post:
2018-08-13
Brief Title:
Comparing Use of a Digital Health System of Pelvic Floor Exercise Program to Kegel Exercises in Stress Urinary Incontinence
Sponsor:
Renovia Inc
Organization:
Renovia Inc
Study Overview
Official Title:
A Prospective Randomized Efficacy Study Comparing a Pelvic Digital Health System Home Program of Pelvic Floor Muscle Exercise to Kegel Exercises in the Treatment of Stress-Predominant Urinary Incontinence
Status:
COMPLETED
Status Verified Date:
2019-07
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:
A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinence Subjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone
Detailed Description:
A randomized controlled trial for patients with stress urinary incontinence or stress-dominant mixed incontinenceSubjects will be randomized to 8-weeks of home kegel exercises or 8 weeks of pelvic floor muscle exercises using the leva digital pelvic health system that includes visual biofeedback via smartphone Leva subjects will perform guided pelvic floor muscle exercises for 2 12 minutes twice daily Home kegel subjects will perform kegel exercises three times daily Following 8-weeks of training subjects will be permitted to continue the exercises or pursue additional therapies as indicated Subjects randomized to the leva digital health system will be further randomized to receive automated reminders for the remainder of one year or no additional reminders
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None