Feasibility of Pelvic Floor Muscle Training With a Digital Therapeutic Motion-based Device (Leva Device) in a Postpartum Population
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of South Florida
- Enrollment
- 25
- Locations
- 2
- Primary Endpoint
- Feasibility
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Device Feasibility
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Device Arm
Participants in this arm will use a digital therapeutic motion-based device for postpartum pelvic floor muscle training
Intervention: Digital therapeutic motion-based device (Device)
Outcomes
Primary Outcomes
Feasibility
Time Frame: From enrollment to 6 months postpartum
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.
Perineal Pain
Time Frame: From enrollment to 6 months postpartum
Participants will complete validated surveys assessing perineal pain at baseline, 3 months postpartum, and 6 months postpartum.
Secondary Outcomes
- Bladder function(From enrollment to 6 months postpartum)
- Bowel Function(From enrollment to 6 months postpartum)
- Pelvic Organ Prolapse(From enrollment to 6 months postpartum)
- Vaginal pain(From enrollment to 6 months postpartum)
- Sexual function(From enrollment to 6 months postpartum)