Clinical Trial

Postpartum pElvic Assisted Recovery With Leva

Study acronym: PEARL
Recruiting
View on ClinicalTrials.gov →
Record status
This record was last updated July 29, 2025 (before its estimated November 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-09-20.
Status change: Not Yet Recruiting → Recruiting 2025-07-24
Trial Details
NCT Number NCT06609317
Lead Sponsor University of South Florida
Conditions Postpartum Pelvic Floor Function and Symptoms
Enrollment 25 participants
Start Date 2025-04-04
Primary Completion 2025-11 (estimated)
Study Completion 2026-02 (estimated)
Updated on ClinicalTrials.gov 2025-07-29