Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06609317
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
Postpartum pElvic Assisted Recovery With Leva
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility of Pelvic Floor Muscle Training With a Digital Therapeutic Motion-based Device Leva Device in a Postpartum Population
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PEARL
Brief Summary:
The goal of this prospective cohort study is to evaluate the feasibility of postpartum pelvic floor muscle training using an FDA-cleared digital therapeutic motion-based device
In addition to assessing feasibility investigators also will evaluate bladder and bowel function pelvic organ prolapse symptoms and vaginal and perineal pain in the immediate postpartum period and at 3 and 6 months postpartum Investigators also will assess sexual function at 3 and 6 months postpartum
Participants will use the motion-based device for postpartum pelvic floor muscle training and will complete electronically administered surveys at 3 and 6 months postpartum
In addition to assessing feasibility investigators also will evaluate bladder and bowel function pelvic organ prolapse symptoms and vaginal and perineal pain in the immediate postpartum period and at 3 and 6 months postpartum Investigators also will assess sexual function at 3 and 6 months postpartum
Participants will use the motion-based device for postpartum pelvic floor muscle training and will complete electronically administered surveys at 3 and 6 months postpartum
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None