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 range

18 Years

Sex

FEMALE

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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

View on ClinicalTrials.gov More Urinary Incontinence trials