Home Biofeedback or Pelvic Floor Physical Therapy for Postpartum Urinary Incontinence.

Stopped early · Not applicable

Conditions studied: Urinary Incontinence, Pelvic Floor Disorders

In brief

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 (PFPT) and home biofeedback devices have been shown to improve pelvic floor symptoms in postpartum and non-postpartum populations, respectively. This randomized noninferiority clinical trial will assess urinary incontinence-related quality of life in postpartum women with self-reported urinary incontinence who are randomized to a program of home biofeedback or pelvic floor physical therapy.

Key facts

Study ID

NCT05194462

Run by

Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)

People needed

3

Starts

2024-03-01

Expected to finish

2025-05-08

Last updated by the study team

2025-06-19

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• AHN Forbes Hospital — Monroeville, Pennsylvania, United States
• West Penn Hospital — Pittsburgh, Pennsylvania, United States
• AHN Wexford Hospital — Wexford, Pennsylvania, United States

Full record on ClinicalTrials.gov

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