PEARLDigital Therapeutic Device for Postpartum Pelvic Floor Training
Digital therapeutic motion-based device
Device Feasibility Study
Summary
Study start date: April 4, 2025
Actual date on which the first participant was enrolled.This study focuses on understanding how practical it is for new mothers to use a special device called the Leva Device, designed to help strengthen pelvic floor muscles. This device is approved by the FDA and uses motion technology to assist in exercises. The study specifically targets women who have recently given birth, aiming to see if the device can help improve areas such as bladder and bowel function, reduce pelvic organ prolapse symptoms, and ease vaginal and perineal pain. Additionally, the study looks at how sexual function might change for these women in the months following childbirth, considering the potential for improved recovery and quality of life. Participants in the study will use the Leva Device to perform exercises that help strengthen their pelvic floor muscles. They will also fill out online surveys at three and six months after giving birth to provide feedback on their progress and any changes in symptoms. The study aims to measure how effective the device is in helping with postpartum recovery, focusing on areas like bladder control and pelvic pain. The use of the device is non-invasive and provides a potential new way for postpartum women to enhance their recovery process.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.25 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Device Feasibility Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 2 locations
Ohio State University Wexner Medical Center
Columbus, United States