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

Last updated: April 18, 2025
Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Urinary Incontinence

Enuresis

Treatment

Questionnaires-No Intervention

Pericoach® by Analytica

Pelvic Floor Physical Therapy

Clinical Study ID

NCT05194462
POUT/IRB00297309
  • Ages > 18
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • following a vaginal delivery (primiparous or multiparous, spontaneous, forceps, orvacuum 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 aspatient report of any urinary leakage within the prior two weeks

Exclusion

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

Study Design

Total Participants: 70
Treatment Group(s): 3
Primary Treatment: Questionnaires-No Intervention
Phase:
Study Start date:
March 01, 2024
Estimated Completion Date:
January 31, 2026

Study 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 noninferiority clinical trial. The hypothesis is that both interventions will improve incontinence-related quality of life and that home biofeedback will be noninferior to PFPT. Two specific aims will be investigated: 1) Determine the impact of both interventions on urinary incontinence-related quality of life measured by the change in score at 3-months on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF); 2) Determine patient impression of symptoms improvement (measured by the change in score at 3-months and 1-year on the Patient Global Impression of Improvement scale or PGI-I), overall pelvic floor symptoms (measured by the change in score at 3-months and 1-year on the Pelvic Floor Distress Inventory of PFDI) and changes in sexual function (measured by a change in score at 3-months and 1-year in the Female Sexual Function Index or FSFI). An additional exploratory aim will be to observe the change in pelvic floor symptoms in the postpartum period at 3-months and 1-year among a cohort of women who elect for the standard of care without PFPT or biofeedback.

Connect with a study center

  • AHN Forbes Hospital

    Monroeville, Pennsylvania 15146
    United States

    Site Not Available

  • West Penn Hospital

    Pittsburgh, Pennsylvania 15224
    United States

    Site Not Available

  • AHN Wexford Hospital

    Wexford, Pennsylvania 15090
    United States

    Site Not Available

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