Recruiting

PEARLDigital Therapeutic Device for Postpartum Pelvic Floor Training

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What is being tested

Digital therapeutic motion-based device

Device
Who is being recruted

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Device Feasibility Study

Interventional
Study Start: April 2025
See protocol details

Summary

Principal SponsorUniversity of South Florida
Study ContactKatie Propst, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

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.

Official TitleFeasibility of Pelvic Floor Muscle Training With a Digital Therapeutic Motion-based Device (Leva Device) in a Postpartum Population
Principal SponsorUniversity of South Florida
Study ContactKatie Propst, MDMore contacts
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

25 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Device Feasibility Study

These studies test whether a new medical device (like a tool or piece of equipment) is safe and practical to use. They're usually small and focus on how the device works rather than how well it treats a condition.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

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

6 inclusion criteria required to participate
Spontaneous vaginal delivery within the last 4-8 weeks

Age ≥ 18 years

Ambulatory

Willing and able to consent to participate.

Show More Criteria

5 exclusion criteria prevent from participating
Operative or cesarean delivery

Obstetric delivery at less than 20 weeks gestation

Third- or fourth-degree perineal laceration

Episiotomy

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Participants in this arm will use a digital therapeutic motion-based device for postpartum pelvic floor muscle training

Study 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

Recruiting

University of South Florida

Tampa, United StatesOpen University of South Florida in Google Maps
Recruiting

Ohio State University Wexner Medical Center

Columbus, United States
Recruiting
2 Study Centers
PEARL | Digital Therapeutic Device for Postpartum Pelvic Floor Training | PatLynk