Postpartum pElvic Assisted Recovery With Leva

Conditions

• Postpartum Pelvic Floor Function and Symptoms

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date

Apr 4, 2025

Status verified

Jul 2025

Primary completion

Nov 30, 2025

Completion

Feb 28, 2026

Study Design

Enrollment

25 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Arms

• Experimental: Device Arm
  Participants in this arm will use a digital therapeutic motion-based device for postpartum pelvic floor muscle training

Primary Outcome Measure

Feasibility [ Time Frame: From enrollment to 6 months postpartum ]

Central Contacts

• Katie Propst, MD
  813-259-0655
  [email protected]
• Maha Al Jumaily, MBBS
  813-259-8680
  [email protected]

Locations (2)

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