Status:
RECRUITING
Postpartum pElvic Assisted Recovery With Leva
Lead Sponsor:
University of South Florida
Conditions:
Postpartum Pelvic Floor Function and Symptoms
Eligibility:
FEMALE
18+ years
Phase:
NA
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 assess...
Eligibility Criteria
Inclusion
- Spontaneous vaginal delivery within the last 4-8 weeks
- Age ≥ 18 years
- Ambulatory
- Willing and able to consent to participate.
- English speaking
- Owns a smartphone
Exclusion
- Operative or cesarean delivery
- Obstetric delivery at less than 20 weeks gestation
- Third- or fourth-degree perineal laceration
- Episiotomy
- Multiples
Key Trial Info
Start Date :
April 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT06609317
Start Date
April 4 2025
End Date
February 1 2026
Last Update
July 29 2025
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University of South Florida
Tampa, Florida, United States, 33606
2
Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210