TerminatedNot Applicable

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

Stopped: low accrual

United States3 participantsStarted 2024-03-01

Plain-language 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 (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.

Who can participate

Age range18 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Criteria: * 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

What they're measuring

Determine the impact of both interventions on urinary incontinence-related quality of life using validated questionnaire

Timeframe: 3 months

Trial details

NCT IDNCT05194462

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-05-08