NCT06609317

Postpartum pElvic Assisted Recovery With Leva

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (estimated)
• Sponsor: University of South Florida · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DEVICE	Digital therapeutic motion-based device	This intervention includes use of a digital therapeutic motion-based device for pelvic floor muscle training

Timeline

• Start date: 2025-04-04
• Primary completion: 2025-11-01
• Completion: 2026-02-01
• First posted: 2024-09-24
• Last updated: 2025-07-29

Locations

2 sites across 1 country: United States