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RECRUITING
NCT06609317
NA

Postpartum pElvic Assisted Recovery With Leva

Sponsor: University of South Florida

View on ClinicalTrials.gov

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.

Official title: Feasibility of Pelvic Floor Muscle Training With a Digital Therapeutic Motion-based Device (Leva Device) in a Postpartum Population

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

25

Start Date

2025-04-04

Completion Date

2026-02

Last Updated

2025-07-29

Healthy Volunteers

No

Interventions

DEVICE

Digital therapeutic motion-based device

This intervention includes use of a digital therapeutic motion-based device for pelvic floor muscle training

Locations (2)

University of South Florida

Tampa, Florida, United States

Ohio State University Wexner Medical Center

Columbus, Ohio, United States