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NCT06609317NARecruiting

Postpartum pElvic Assisted Recovery With Leva

University of South Florida

Start Date

4/4/2025

Completion Date

2/1/2026

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 Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Digital therapeutic motion-based device

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Conditions

Postpartum Pelvic Floor Function and Symptoms

Locations

University of South Florida

Tampa, Florida 33606

United States

Ohio State University Wexner Medical Center

Columbus, Ohio 43210

United States