Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06609317

Postpartum pElvic Assisted Recovery With Leva

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Postpartum Pelvic Floor Function and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of South Florida, Tampa, Florida, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digital therapeutic motion-based device

Device

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

Primary outcomes

  1. Feasibility

    Time frame: From enrollment to 6 months postpartum

    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.

  2. Perineal Pain

    Time frame: From enrollment to 6 months postpartum

    Participants will complete validated surveys assessing perineal pain at baseline, 3 months postpartum, and 6 months postpartum.

Secondary outcomes

  1. Bladder function

    Time frame: From enrollment to 6 months postpartum

    Participants will complete validated surveys assessing bladder function at baseline, 3 months postpartum, and 6 months postpartum.

  2. Bowel Function

    Time frame: From enrollment to 6 months postpartum

    Participants will complete validated surveys assessing bowel function at baseline, 3 months postpartum, and 6 months postpartum.

  3. Pelvic Organ Prolapse

    Time frame: From enrollment to 6 months postpartum

    Participants will complete validated surveys assessing pelvic organ prolapse symptoms at baseline, 3 months postpartum, and 6 months postpartum.

  4. Vaginal pain

    Time frame: From enrollment to 6 months postpartum

    Participants will complete validated surveys assessing vaginal pain at baseline, 3 months postpartum, and 6 months postpartum.

  5. Sexual function

    Time frame: From enrollment to 6 months postpartum

    Participants will complete validated surveys assessing sexual function at 3 months postpartum and 6 months postpartum.

Study contacts

Contact information is provided by the study sponsor or research team.

Katie Propst, MD

CONTACT

[email protected]

813-259-0655

Maha Al Jumaily, MBBS

CONTACT

[email protected]

813-259-8680

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

Feasibility of Pelvic Floor Muscle Training With a Digital Therapeutic Motion-based Device (Leva Device) in a Postpartum Population

Acronym: PEARL

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Sep 24, 2024
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.