Postpartum pElvic Assisted Recovery With Leva (PEARL)

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

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

• Status: Recruiting
• Conditions: Postpartum Pelvic Floor Function and Symptoms
• Intervention / Treatment: Device: Digital therapeutic motion-based device

• Study Type: Interventional
• Enrollment (Estimated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Katie Propst, MD; Phone Number: 813-259-0655; Email: katiepropst@usf.edu
• Study Contact Backup: Name: Maha Al Jumaily, MBBS; Phone Number: 813-259-8680; Email: mahaaljumaily@usf.edu

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Recruiting
      • University of South Florida
      • Contact: Maha Al Jumaily, MBBS; Phone Number: 813-259-8680; Email: mahaaljumaily@usf.edu
      • Principal Investigator: Katie Propst, MD
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Recruiting
      • Ohio State University Wexner Medical Center
      • Contact: Lisa Hickman, MD; Phone Number: 614-293-4643; Email: PEARLstudy@osumc.edu
      • Principal Investigator: Lisa Hickman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Device Arm; Participants in this arm will use a digital therapeutic motion-based device for postpartum pelvic floor muscle training	Device: Digital therapeutic motion-based device; This intervention includes use of a digital therapeutic motion-based device for pelvic floor muscle training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility	Feasibility will be assessed using participant reported discomfort with device use, ease of device use, net promotor score, patient satisfaction, and free text feedback on the device.	From enrollment to 6 months postpartum
Perineal Pain	Participants will complete validated surveys assessing perineal pain at baseline, 3 months postpartum, and 6 months postpartum.	From enrollment to 6 months postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bladder function	Participants will complete validated surveys assessing bladder function at baseline, 3 months postpartum, and 6 months postpartum.	From enrollment to 6 months postpartum
Bowel Function	Participants will complete validated surveys assessing bowel function at baseline, 3 months postpartum, and 6 months postpartum.	From enrollment to 6 months postpartum
Pelvic Organ Prolapse	Participants will complete validated surveys assessing pelvic organ prolapse symptoms at baseline, 3 months postpartum, and 6 months postpartum.	From enrollment to 6 months postpartum
Vaginal pain	Participants will complete validated surveys assessing vaginal pain at baseline, 3 months postpartum, and 6 months postpartum.	From enrollment to 6 months postpartum
Sexual function	Participants will complete validated surveys assessing sexual function at 3 months postpartum and 6 months postpartum.	From enrollment to 6 months postpartum

Collaborators and Investigators

• Sponsor: University of South Florida

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2025
• Primary Completion (Estimated): November 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: postpartum pelvic floor; postpartum pelvic muscle training; postpartum pelvic floor physical therapy; postpartum urinary incontinence; postpartum bowel incontinence; postpartum pelvic floor recovery
• Other Study ID Numbers: 007382

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No