Postpartum pElvic Assisted Recovery With Leva

Not Applicable

Not yet recruiting

• Conditions: Postpartum Pelvic Floor Function and Symptoms
• Interventions: Device: Digital therapeutic motion-based device

• Registration Number: NCT06609317
• Lead Sponsor: University of South Florida

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-20
• Last Update Submitted: 2024-09-20
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24
• Study Start: 2024-10-15
• Primary Completion: 2025-06-15
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 25

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Device Arm	Digital therapeutic motion-based device	Participants in this arm will use a digital therapeutic motion-based device for postpartum pelvic floor muscle training

Primary Outcome Measures

Name	Time	Method
Feasibility	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	From enrollment to 6 months postpartum	Participants will complete validated surveys assessing perineal pain at baseline, 3 months postpartum, and 6 months postpartum.

Secondary Outcome Measures

Name	Time	Method
Bladder function	From enrollment to 6 months postpartum	Participants will complete validated surveys assessing bladder function at baseline, 3 months postpartum, and 6 months postpartum.
Bowel Function	From enrollment to 6 months postpartum	Participants will complete validated surveys assessing bowel function at baseline, 3 months postpartum, and 6 months postpartum.
Pelvic Organ Prolapse	From enrollment to 6 months postpartum	Participants will complete validated surveys assessing pelvic organ prolapse symptoms at baseline, 3 months postpartum, and 6 months postpartum.
Vaginal pain	From enrollment to 6 months postpartum	Participants will complete validated surveys assessing vaginal pain at baseline, 3 months postpartum, and 6 months postpartum.
Sexual function	From enrollment to 6 months postpartum	Participants will complete validated surveys assessing sexual function at 3 months postpartum and 6 months postpartum.