Status:
TERMINATED
Home Biofeedback or Pelvic Floor Physical Therapy for Postpartum Urinary Incontinence.
Lead Sponsor:
Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Collaborating Sponsors:
Johns Hopkins University
Conditions:
Urinary Incontinence
Pelvic Floor Disorders
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Pelvic floor dysfunction is commonly seen in the postpartum women with symptoms including urinary urgency and frequency, urinary incontinence and fecal incontinence. Pelvic floor physical therapy (PFP...
Detailed Description
The objective of this proposal is to determine if home biofeedback devices are noninferior to pelvic floor physical therapy for the treatment of postpartum urinary incontinence through a randomized no...
Eligibility Criteria
Inclusion
- following a vaginal delivery (primiparous or multiparous, spontaneous, forceps, or vacuum assisted)
- willingness to participate in PFPT or home biofeedback exercises
- access to a smartphone with Bluetooth capabilities
- positive screen for urinary incontinence between 4 and 8 weeks postpartum defined as patient report of any urinary leakage within the prior two weeks
Exclusion
- multiple births or deliver at ≤34 weeks
- previous urinary incontinence or pelvic organ prolapse surgery
- self-identified pre-pregnancy pelvic floor disorder such as urinary incontinence
- fecal incontinence or chronic pelvic pain or if they have a history of prior PFPT
Key Trial Info
Start Date :
March 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 8 2025
Estimated Enrollment :
3 Patients enrolled
Trial Details
Trial ID
NCT05194462
Start Date
March 1 2024
End Date
May 8 2025
Last Update
June 19 2025
Active Locations (3)
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1
AHN Forbes Hospital
Monroeville, Pennsylvania, United States, 15146
2
West Penn Hospital
Pittsburgh, Pennsylvania, United States, 15224
3
AHN Wexford Hospital
Wexford, Pennsylvania, United States, 15090