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Recruiting NCT06609317

Postpartum pElvic Assisted Recovery With Leva

No phase Interventional Postpartum Pelvic Floor Function and Symptoms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Digital therapeutic motion-based device.
Who it may be relevant to
Registry conditions: Postpartum Pelvic Floor Function and Symptoms. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

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

Primary outcome measures

  • Feasibility [Time frame: From enrollment to 6 months postpartum]
  • Perineal Pain [Time frame: From enrollment to 6 months postpartum]
Secondary outcome measures (5)
  • Bladder function [Time frame: From enrollment to 6 months postpartum]
  • Bowel Function [Time frame: From enrollment to 6 months postpartum]
  • Pelvic Organ Prolapse [Time frame: From enrollment to 6 months postpartum]
  • Vaginal pain [Time frame: From enrollment to 6 months postpartum]
  • Sexual function [Time frame: From enrollment to 6 months postpartum]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

United States · 2 centers
  • University of South Florida — Tampa
  • Ohio State University Wexner Medical Center — Columbus

Identifiers

NCT: NCT06609317 · 007382

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗