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
University of South Florida
25 participants
Apr 4, 2025
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria6
- 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 Criteria5
- Operative or cesarean delivery
- Obstetric delivery at less than 20 weeks gestation
- Third- or fourth-degree perineal laceration
- Episiotomy
- Multiples
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Interventions
This intervention includes use of a digital therapeutic motion-based device for pelvic floor muscle training
Locations(2)
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NCT06609317