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

NCT05194462 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2025-06-19

No results posted yet for this study

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.

Conditions

Interventions

DEVICE

Pericoach® by Analytica

This intervention 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 .

OTHER

Pelvic Floor Physical Therapy

This intervention will assess urinary incontinence-related quality of life in postpartum women with self-reported urinary incontinence who are randomized to a program of PFPT.

Sponsors & Collaborators

  • Johns Hopkins University

    collaborator OTHER

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

    lead OTHER

Principal Investigators

  • Jessica Sassani, MD · Allegheny Health Network

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2025-05-08
Completion
2025-05-08
FDA Device
Yes

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05194462 on ClinicalTrials.gov