Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
NCT06609317

Postpartum pElvic Assisted Recovery With Leva

Led by University of South Florida · Updated on 2025-07-29

25

Participants Needed

2

Research Sites

43 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Postpartum pElvic Assisted Recovery With Leva

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Spontaneous vaginal delivery within the last 4-8 weeks
  • Age 63 18 years
  • Ambulatory
  • Willing and able to consent to participate
  • English speaking
  • Owns a smartphone
Not Eligible

You will not qualify if you...

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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 2 locations

1

University of South Florida

Tampa, Florida, United States, 33606

Actively Recruiting

2

Ohio State University Wexner Medical Center

Columbus, Ohio, United States, 43210

Actively Recruiting

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Research Team

K

Katie Propst, MD

CONTACT

M

Maha Al Jumaily, MBBS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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