Actively Recruiting
Postpartum pElvic Assisted Recovery With Leva
Led by University of South Florida · Updated on 2025-07-29
25
Participants Needed
2
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Postpartum pElvic Assisted Recovery With Leva
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Spontaneous vaginal delivery within the last 4-8 weeks
- Age 63 18 years
- Ambulatory
- Willing and able to consent to participate
- English speaking
- Owns a smartphone
You will not qualify if you...
- Operative or cesarean delivery
- Obstetric delivery at less than 20 weeks gestation
- Third- or fourth-degree perineal laceration
- Episiotomy
- Multiples
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
University of South Florida
Tampa, Florida, United States, 33606
Actively Recruiting
2
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Actively Recruiting
Research Team
K
Katie Propst, MD
CONTACT
M
Maha Al Jumaily, MBBS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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