RECRUITING

Postpartum pElvic Assisted Recovery With Leva

Description

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.

Study Overview

Study Details

Study overview

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.

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

Postpartum pElvic Assisted Recovery With Leva

Condition
Postpartum Pelvic Floor Function and Symptoms
Intervention / Treatment

-

Contacts and Locations

Tampa

University of South Florida, Tampa, Florida, United States, 33606

Columbus

Ohio State University Wexner Medical Center, Columbus, Ohio, United States, 43210

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of South Florida,

Study Record Dates

2026-02