Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Device Arm | Experimental | Participants in this arm will use a digital therapeutic motion-based device for postpartum pelvic floor muscle training |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital therapeutic motion-based device | Device | This intervention includes use of a digital therapeutic motion-based device for pelvic floor muscle training |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment to 6 months postpartum |
| Perineal Pain | Participants will complete validated surveys assessing perineal pain at baseline, 3 months postpartum, and 6 months postpartum. | From enrollment to 6 months postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Bladder function | Participants will complete validated surveys assessing bladder function at baseline, 3 months postpartum, and 6 months postpartum. | From enrollment to 6 months postpartum |
| Bowel Function |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Katie Propst, MD | Contact | 813-259-0655 | katiepropst@usf.edu | |
| Maha Al Jumaily, MBBS | Contact | 813-259-8680 | mahaaljumaily@usf.edu |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Recruiting | Tampa | Florida | 33606 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Participants will complete validated surveys assessing bowel function at baseline, 3 months postpartum, and 6 months postpartum.
| From enrollment to 6 months postpartum |
| Pelvic Organ Prolapse | Participants will complete validated surveys assessing pelvic organ prolapse symptoms at baseline, 3 months postpartum, and 6 months postpartum. | From enrollment to 6 months postpartum |
| Vaginal pain | Participants will complete validated surveys assessing vaginal pain at baseline, 3 months postpartum, and 6 months postpartum. | From enrollment to 6 months postpartum |
| Sexual function | Participants will complete validated surveys assessing sexual function at 3 months postpartum and 6 months postpartum. | From enrollment to 6 months postpartum |
| Ohio State University Wexner Medical Center | Recruiting | Columbus | Ohio | 43210 | United States |
|