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

Home Biofeedback or Pelvic Floor Physical Therapy for Postpartum Urinary Incontinence.: A Noninferiority Randomized Controlled Trial

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.

Study Overview

• Status: Terminated
• Conditions: Urinary Incontinence; Pelvic Floor Disorders
• Intervention / Treatment: Other: Pelvic Floor Physical Therapy; Device: Pericoach® by Analytica

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Monroeville, Pennsylvania, United States, 15146
      • AHN Forbes Hospital
    • Pittsburgh, Pennsylvania, United States, 15224
      • West Penn Hospital
    • Wexford, Pennsylvania, United States, 15090
      • AHN Wexford Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Pelvic Floor Physical Therapy (PFPT); 6 sessions of PFPT over a 12 week period with planned home exercises as per physical therapist's recommendation.	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.
Active Comparator: Biofeedback device; Pericoach® by Analytica is a vaginal device with recommendation for daily use during the 12 week period.	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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the impact of both interventions on urinary incontinence-related quality of life using validated questionnaire	Measured by the change in score on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) between baseline and 3 months; scored between 0 and 21 with higher score meaning larger symptom burden	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine the impact of both interventions on urinary incontinence-related quality of life using validated questionnaire	Measured by the change in score on the International Consultation on Incontinence Questionnaire Short Form (ICIQ-SF) between baseline and 12 months; scored between 0 and 21 with higher score meaning larger symptom burden	12 months
Determine overall pelvic floor symptoms measured by validated questionnaire	Measured by change in score on the Pelvic Floor Distress Inventory (PFD-I) between baseline and 3 months; scored between 0 and 300 with higher score indicating greater symptom burden	3 months
Determine overall pelvic floor symptoms measured by validated questionnaire	Measured by change in score on the Pelvic Floor Distress Inventory (PFD-I) between baseline and 12 months; scored between 0 and 300 with higher score indicating greater symptom burden	12 months
Determine changes in sexual function following intervention measured by validated questionnaire	Measured by change in score on the Female Sexual Function Index (FSFI) between baseline and 3 months; scored between 2 and 36 with a lower score indicating more sexual dysfunction	3 months
Determine changes in sexual function following intervention measured by validated questionnaire	Measured by change in score on the Female Sexual Function Index (FSFI) between baseline and 12 months; scored between 2 and 36 with a lower score indicating more sexual dysfunction	12 months
Determine the patient impression of symptom improvement using validated questionnaire	Measured by the change in score on the Patient Global Impression of Improvement (PGI-I) between baseline and 3 months; scored between 1 and 7 with higher scoring meaning worsening symptoms	3 months
Determine the patient impression of symptom improvement using validated questionnaire	Measured by the change in score on the Patient Global Impression of Improvement (PGI-I) between baseline and 12 months; scored between 1 and 7 with higher scoring meaning worsening symptoms	12 months

Collaborators and Investigators

• Sponsor: Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute)
• Collaborators: Johns Hopkins University
• Investigators: Principal Investigator: Jessica Sassani, MD, Allegheny Health Network

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): May 8, 2025
• Study Completion (Actual): May 8, 2025

Study Registration Dates

• First Submitted: September 19, 2021
• First Submitted That Met QC Criteria: January 13, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): June 19, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Mental Disorders; Male Urogenital Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Pregnancy Complications; Urination Disorders; Lower Urinary Tract Symptoms; Urological Manifestations; Behavioral Symptoms; Elimination Disorders; Urinary Incontinence; Enuresis; Pelvic Floor Disorders
• Other Study ID Numbers: POUT/IRB00297309

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Results will be published; patient identifiers will not be used in the research publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No