Postpartum pElvic Assisted Recovery With Leva

Recruiting now · Not applicable

Conditions studied: Postpartum Pelvic Floor Function and Symptoms

In brief

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.

Key facts

Study ID

NCT06609317

Run by

University of South Florida

People needed

25

Starts

2025-04-04

Expected to finish

2026-02-01

Last updated by the study team

2025-07-29

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Operative or cesarean delivery
• Obstetric delivery at less than 20 weeks gestation
• Third- or fourth-degree perineal laceration
• Episiotomy
• Multiples

Where it is running

• University of South Florida — Tampa, Florida, United States (enrolling)
• Ohio State University Wexner Medical Center — Columbus, Ohio, United States (enrolling)

Full record on ClinicalTrials.gov

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