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Postpartum pElvic Assisted Recovery With Leva
Feasibility of Pelvic Floor Muscle Training With a Digital Therapeutic Motion-based Device (Leva Device) in a Postpartum Population
Who can join
Ages 18 and older · Women
Full eligibility criteria
Inclusion Criteria: * 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 Criteria: * Operative or cesarean delivery * Obstetric delivery at less than 20 weeks gestation * Third- or fourth-degree perineal laceration * Episiotomy * Multiples
About the study
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.
What is being tested
- Digital therapeutic motion-based device (device)
Sponsor: University of South Florida · Participants: 25 · Started: Apr 4, 2025
Contact the study team
- Katie Propst, MD · Phone: 813-259-0655
- Maha Al Jumaily, MBBS · Phone: 813-259-8680
Official record on ClinicalTrials.gov — NCT06609317
Locations in the U.S.
| Florida | University of South Florida, Tampa |
| Ohio | Ohio State University Wexner Medical Center, Columbus |
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.