Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
25 participants
INTERVENTIONAL
2025-04-04
2026-02-28
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DEVICE_FEASIBILITY
NONE
Study Groups
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Device Arm
Participants in this arm will use a digital therapeutic motion-based device for postpartum pelvic floor muscle training
Digital therapeutic motion-based device
This intervention includes use of a digital therapeutic motion-based device for pelvic floor muscle training
Interventions
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Digital therapeutic motion-based device
This intervention includes use of a digital therapeutic motion-based device for pelvic floor muscle training
Eligibility Criteria
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Inclusion Criteria
* Age ≥ 18 years
* Ambulatory
* Willing and able to consent to participate.
* English speaking
* Owns a smartphone
Exclusion Criteria
* Obstetric delivery at less than 20 weeks gestation
* Third- or fourth-degree perineal laceration
* Episiotomy
* Multiples
18 Years
FEMALE
No
Sponsors
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University of South Florida
OTHER
Responsible Party
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Locations
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University of South Florida
Tampa, Florida, United States
Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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007382
Identifier Type: -
Identifier Source: org_study_id
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