Postpartum Pelvic Floor Function and Symptoms
Conditions
Keywords
postpartum pelvic muscle training, postpartum pelvic floor, postpartum pelvic floor physical therapy, postpartum urinary incontinence, postpartum bowel incontinence, postpartum pelvic floor recovery
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.
Interventions
DEVICEDigital therapeutic motion-based device
This intervention includes use of a digital therapeutic motion-based device for pelvic floor muscle training
Sponsors
University of South Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| Sexual function | From enrollment to 6 months postpartum | Participants will complete validated surveys assessing sexual function at 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. |
| 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. |
Countries
United States
Contacts
Primary ContactKatie Propst, MD
Backup ContactMaha Al Jumaily, MBBS
Outcome results
None listed