Postpartum pElvic Assisted Recovery With Leva

NCT ID: NCT06609317

Last Updated: 2025-07-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-04

Study Completion Date

2026-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Postpartum Pelvic Floor Function and Symptoms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Device Arm

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

Group Type EXPERIMENTAL

Digital therapeutic motion-based device

Intervention Type DEVICE

This intervention includes use of a digital therapeutic motion-based device for pelvic floor muscle training

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Digital therapeutic motion-based device

This intervention includes use of a digital therapeutic motion-based device for pelvic floor muscle training

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of South Florida

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of South Florida

Tampa, Florida, United States

Site Status RECRUITING

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Katie Propst, MD

Role: CONTACT

813-259-0655

Maha Al Jumaily, MBBS

Role: CONTACT

813-259-8680

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Maha Al Jumaily, MBBS

Role: primary

813-259-8680

Lisa Hickman, MD

Role: primary

614-293-4643

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

007382

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Postpartum Pelvic Floor Workshop
NCT04754984 COMPLETED NA