Postpartum pElvic Assisted Recovery With Leva

NCT06609317 | Recruiting

• 1 other identifier: 007382
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Postpartum Pelvic Floor Function and Symptoms

Keywords

postpartum pelvic muscle training; postpartum pelvic floor; postpartum pelvic floor physical therapy; postpartum urinary incontinence; postpartum bowel incontinence; postpartum pelvic floor recovery

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (5)

• Bladder function

  From enrollment to 6 months postpartum

• Bowel Function

  From enrollment to 6 months postpartum

• Pelvic Organ Prolapse

  From enrollment to 6 months postpartum

• Vaginal pain

  From enrollment to 6 months postpartum

• Sexual function

  From enrollment to 6 months postpartum

Study Arms (1)

Device Arm

EXPERIMENTAL

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

Device: Digital therapeutic motion-based device

Interventions

Digital therapeutic motion-based device DEVICE

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

Device Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Operative or cesarean delivery
• Obstetric delivery at less than 20 weeks gestation
• Third- or fourth-degree perineal laceration
• Episiotomy
• Multiples

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (2)

University of South Florida

Tampa, Florida, 33606, United States

RECRUITING

Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

RECRUITING

Central Study Contacts

Katie Propst, MD

CONTACT

813-259-0655; katiepropst@usf.edu

Maha Al Jumaily, MBBS

CONTACT

813-259-8680; mahaaljumaily@usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: April 4, 2025
• Primary Completion: November 1, 2025
• Study Completion: February 1, 2026
• Last Updated: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)