Postpartum pElvic Assisted Recovery With Leva

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of South Florida

About this trial

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 criteria

Qualifiers

Spontaneous vaginal delivery within the last 4-8 weeks

Age ≥ 18 years

Ambulatory

Willing and able to consent to participate.

Disqualifiers

Operative or cesarean delivery

Obstetric delivery at less than 20 weeks gestation

Third- or fourth-degree perineal laceration

Episiotomy

Trial design

Treatments tested in this trial

  • Digital therapeutic motion-based device

Treatment groups

25 Participants
are divided into 1 treatment group

Sponsors and collaborators