Postpartum pElvic Assisted Recovery With Leva

University of South Florida25 enrolled

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

Postpartum Pelvic Floor Function and Symptoms

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (2)

University of South Florida

Tampa, Florida, United States

RECRUITING

Ohio State University Wexner Medical Center

Columbus, Ohio, United States

RECRUITING

Outcomes

Primary Outcomes

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.