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Clinical Trials/NCT07553884
NCT07553884
Not yet recruiting
Not Applicable

Knowledge, Awareness, and Understanding of Stress Urinary Incontinence in Patients Attending a Urogynecology Clinic

Sunnybrook Health Sciences Centre1 site in 1 country90 target enrollmentStarted: April 30, 2026Last updated:

Overview

Phase
Not Applicable
Status
Not yet recruiting
Enrollment
90
Locations
1
Primary Endpoint
Change in the total score of the SUI knowledge questionnaire

Overview

Brief Summary

The goal of this prospective study is to assess whether a standardized educational flyer (pamphlet) improves knowledge about stress urinary incontinence (SUI) in adult females attending a urogynecology clinic. It will also explore how participant characteristics relate to treatment preferences.

The main questions it aims to answer are:

Does reading a standardized SUI patient information flyer improve participants' knowledge of SUI? How do patient characteristics influence treatment preferences for SUI?

Participants will:

Complete a self-administered questionnaire assessing knowledge of SUI, including its definition, pathophysiology, risk factors, natural history, and treatment options (this questionnaire is not part of standard care).

Review a standardized SUI educational flyer during their clinic visit. Complete the same questionnaire again after reading the pamphlet to assess any change in knowledge.

Questionnaire scores before and after reading the flyer will be compared. Secondary outcomes include participant characteristics and reported treatment preferences.

Detailed Description

This prospective study will recruit female adult patients with a clinical diagnosis of stress urinary incontinence (SUI) presenting to a urogynecology clinic at Sunnybrook Health Centre. Consenting participants will complete a self-administered questionnaire (15-item questionnaire) assessing knowledge related to SUI definition, pathophysiology, risk factors, natural history, and available treatment options. Demographic and clinical data, including age, education level, parity, menopausal status, symptom severity, and prior exposure to SUI treatment, SUI treatment preferences and level of education, will be collected.

A standardized patient information SUI flyer by the American Urogynecology Society (AUGS) will be given to the participant to read. Right after reading the flyer, participants will be re-tested with the same self-administered questionnaire (before leaving the clinic visit).

The primary outcome will be the change in the questionnaire (SUI knowledge) total score.

Secondary outcomes include patient characteristics and their treatment preferences.

Descriptive statistics will be used.

Participants who consent to being contacted for study-related updates will be asked to provide their preferred contact information.

Participant contact information will be stored separately from study data in a secure, password-protected electronic file accessible only to authorized members of the research team. Each participant will be assigned a unique study ID, and identifying information will not be linked to questionnaire responses or study outcomes.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants are patients referred to Sunnybrook Health Sciences Centre Urogynecology Clinics with the condition of SUI.
  • ≥ 18 years old
  • Able to provide informed consent and communicate in English

Exclusion Criteria

  • Under the age of 18 years
  • Urge-predominant mixed urinary incontinence or pure urinary urge incontinence
  • Inability to respond to research questionnaires in English
  • Unable to provide informed consent

Arms & Interventions

All participants receive the same intervention and complete the same questionnaire

Consenting new patients presenting to a urogynecology clinic with SUI will 1) complete a 15-item questionnaire upon arrival in the clinic (pre intervention) , 2) will read the SUI educational flyer and 3) complete a post-knowledge questionnaire right after reading the flyer.

Intervention: 15 Item Questionnaire (Other)

Outcomes

Primary Outcomes

Change in the total score of the SUI knowledge questionnaire

Time Frame: At the same clinic visit: from enrollment to completing the post-intervention SUI Knowledge questionnaire

The change in SUI knowledge questionnaire total score (15-item questionnaire, with each correct answer equals 1 point, maximum number of points is 15) before and right after reading the AUGS SUI flyer.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Patricia Lee

Dr

Sunnybrook Health Sciences Centre

Study Sites (1)

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