RECRUITING

Postpartum pElvic Assisted Recovery With Leva

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-04-04
Study Completion:2026-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06609317

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Spontaneous vaginal delivery within the last 4-8 weeks
  2. * Age ≥ 18 years
  3. * Ambulatory
  4. * Willing and able to consent to participate.
  5. * English speaking
  6. * Owns a smartphone
  1. * Operative or cesarean delivery
  2. * Obstetric delivery at less than 20 weeks gestation
  3. * Third- or fourth-degree perineal laceration
  4. * Episiotomy
  5. * Multiples

Contacts and Locations

Study Contact

Katie Propst, MD
CONTACT
813-259-0655
katiepropst@usf.edu
Maha Al Jumaily, MBBS
CONTACT
813-259-8680
mahaaljumaily@usf.edu

Study Locations (Sites)

University of South Florida
Tampa, Florida, 33606
United States
Ohio State University Wexner Medical Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: University of South Florida

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-04
Study Completion Date2026-02

Study Record Updates

Study Start Date2025-04-04
Study Completion Date2026-02

Terms related to this study

Keywords Provided by Researchers

  • postpartum pelvic muscle training
  • postpartum pelvic floor
  • postpartum pelvic floor physical therapy
  • postpartum urinary incontinence
  • postpartum bowel incontinence
  • postpartum pelvic floor recovery

Additional Relevant MeSH Terms

  • Postpartum Pelvic Floor Function and Symptoms