Postpartum pElvic Assisted Recovery With Leva (PEARL)

University of South Florida

Status: Enrolling

Conditions: Postpartum Pelvic Floor Function and Symptoms

Treatments: Device: Digital therapeutic motion-based device

Study type: Interventional

Funder types: Other

Identifiers

NCT06609317

007382

Details and patient eligibility

About

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.

Enrollment: 25 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Device Arm

Experimental group

Description:

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

Treatment:

Device: Digital therapeutic motion-based device