Postpartum pElvic Assisted Recovery With Leva
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of South Florida
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Spontaneous vaginal delivery within the last 4-8 weeks
Age ≥ 18 years
Ambulatory
Willing and able to consent to participate.
Disqualifiers
Operative or cesarean delivery
Obstetric delivery at less than 20 weeks gestation
Third- or fourth-degree perineal laceration
Episiotomy
Trial design
Design model
Single group
Treatments tested in this trial
Digital therapeutic motion-based device
DeviceThis intervention includes use of a digital therapeutic motion-based device for pelvic floor muscle training
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Device ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From enrollment to 6 months postpartum2
Perineal Pain
Participants will complete validated surveys assessing perineal pain at baseline, 3 months postpartum, and 6 months postpartum.
Time frame
From enrollment to 6 months postpartumSecondary outcomes
1
Bladder function
Participants will complete validated surveys assessing bladder function at baseline, 3 months postpartum, and 6 months postpartum.
Time frame
From enrollment to 6 months postpartum2
Bowel Function
Participants will complete validated surveys assessing bowel function at baseline, 3 months postpartum, and 6 months postpartum.
Time frame
From enrollment to 6 months postpartum3
Pelvic Organ Prolapse
Participants will complete validated surveys assessing pelvic organ prolapse symptoms at baseline, 3 months postpartum, and 6 months postpartum.
Time frame
From enrollment to 6 months postpartum4
Vaginal pain
Participants will complete validated surveys assessing vaginal pain at baseline, 3 months postpartum, and 6 months postpartum.
Time frame
From enrollment to 6 months postpartumSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov