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

NCT05194462 | Terminated FDA Device

• 1 other identifier: POUT/IRB00297309
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 3

Brief 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

Urinary Incontinence; Pelvic Floor Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

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

  12 months

• Determine overall pelvic floor symptoms measured by validated questionnaire

  3 months

• Determine overall pelvic floor symptoms measured by validated questionnaire

  12 months

• Determine changes in sexual function following intervention measured by validated questionnaire

  3 months

• Determine changes in sexual function following intervention measured by validated questionnaire

  12 months

Study Arms (2)

Pelvic Floor Physical Therapy (PFPT)

ACTIVE COMPARATOR

6 sessions of PFPT over a 12 week period with planned home exercises as per physical therapist's recommendation.

Other: Pelvic Floor Physical Therapy

Biofeedback device

ACTIVE COMPARATOR

Pericoach® by Analytica is a vaginal device with recommendation for daily use during the 12 week period.

Device: Pericoach® by Analytica

Interventions

Pericoach® by Analytica DEVICE

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 .

Biofeedback device

Pelvic Floor Physical Therapy OTHER

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.

Pelvic Floor Physical Therapy (PFPT)

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Women age 18 of greater following a vaginal delivery.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allegheny Singer Research Institute (also known as Allegheny Health Network Research Institute): lead
• Johns Hopkins University: collaborator

Study Sites (3)

AHN Forbes Hospital

Monroeville, Pennsylvania, 15146, United States

Location

West Penn Hospital

Pittsburgh, Pennsylvania, 15224, United States

Location

AHN Wexford Hospital

Wexford, Pennsylvania, 15090, United States

Location

MeSH Terms

Conditions

Urinary Incontinence; Pelvic Floor Disorders

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pregnancy Complications

Study Officials

• Jessica Sassani, MD

  Allegheny Health Network

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician, Division of Urogynecology, Department of Obstetrics & Gynecology

Study Record Dates

• First Submitted: September 19, 2021
• First Posted: January 18, 2022
• Study Start: March 1, 2024
• Primary Completion: May 8, 2025
• Study Completion: May 8, 2025
• Last Updated: June 19, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)