NCT07553884

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
3mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Apr 2026Jul 2026

First Submitted

Initial submission to the registry

April 8, 2026

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 28, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 30, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2026

Last Updated

April 28, 2026

Status Verified

April 1, 2026

Enrollment Period

3 months

First QC Date

April 8, 2026

Last Update Submit

April 20, 2026

Conditions

Stress Urinary Incontinence (SUI)

Keywords

prospective cohort

Outcome Measures

Primary Outcomes (1)

  • Change in the total score of the 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.

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

Study Arms (1)

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.

Other: 15 Item Questionnaire

Interventions

15 Item QuestionnaireOTHER

Participants will complete a 15-item questionnaire assessing baseline knowledge of SUI. They will then review a standardized patient education Flyer developed by the American Urogynecologic Society (AUGS) about SUI and complete the same questionnaire again right after reading the flyer.

All participants receive the same intervention and complete the same questionnaire

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Population will be new patients referred to Urogynecology clinic at Sunnybrook Health Sciences Centre with clinical presentation of SUI

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sunnybrook Health Sciences Centre

Toronto, Onatrio, M4N 3M5, Canada

Location

Related Publications (11)

  • 11. Dmochowski RR, Newman DK, Johnson CP, Oefelein MG. Patient education in urinary incontinence. Urol Clin North Am. 2010;37(4):495-506. 12. Shaw C, Tansey R, Jackson C, Hyde C, Allan R. Barriers to help seeking in people with urinary symptoms. Fam Pract. 2001;18(1):48-52.

    BACKGROUND

  • 10. Kinchen KS, Burgio K, Diokno AC, Fultz NH, Bump R, Obenchain R. Factors associated with women's decisions to seek treatment for urinary incontinence. J Womens Health. 2003;12(7):687-698.

    BACKGROUND

  • 9. Shaw C, Gupta RD, Bushnell DM, Martin ML. The extent and severity of urinary incontinence amongst women in the UK. BJOG. 2006;113(4):414-421.

    BACKGROUND

  • 8. Coyne KS, Wein A, Nicholson S, Kvasz M, Chen CI, Milsom I. Comorbidities and personal burden of urgency urinary incontinence. BJU Int. 2014;113(3):438-444.

    BACKGROUND

  • 7. Subak LL, Brown JS, Kraus SR, Brubaker L, Lin F, Richter HE, et al. The costs of urinary incontinence for women. Obstet Gynecol. 2006;107(4):908-916.

    BACKGROUND

  • 6. Hannestad YS, Rortveit G, Sandvik H, Hunskaar S. A community-based epidemiological survey of female urinary incontinence. J Clin Epidemiol. 2000;53(11):1150-1157.

    BACKGROUND

  • 5. Milsom I, Altman D, Lapitan MC, Nelson R, Sillén U, Thom D. Epidemiology of urinary incontinence and other lower urinary tract symptoms. In: Abrams P, Cardozo L, Khoury S, Wein A, editors. Incontinence. 4th ed. Paris: Health Publication Ltd; 2009.

    BACKGROUND

  • 4. Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, et al. The standardisation of terminology of lower urinary tract function. Neurourol Urodyn. 2003;21(2):167-178.

    BACKGROUND

  • 3. Minassian VA, Drutz HP, Al-Badr A. Urinary incontinence as a worldwide problem. Int J Gynaecol Obstet. 2003;82(3):327-338.

    BACKGROUND

  • 2. Wu JM, Vaughan CP, Goode PS, Redden DT, Burgio KL, Richter HE, Markland AD. Prevalence and trends of symptomatic pelvic floor disorders in US women. Obstet Gynecol. 2014;123(1):141-148.

    BACKGROUND

  • 1. Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, et al. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008;300(11):1311-1316.

    BACKGROUND

MeSH Terms

Conditions

Urinary Incontinence, Stress

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Aysha Nedham, MD, FRCSC

CONTACT

1-416-480-6100aysha.nedham@sunnybrook.ca

Razia Sultana, MD, PhD

CONTACT

Razia.sultana@sri.utoronto.ca

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

April 8, 2026

First Posted

April 28, 2026

Study Start

April 30, 2026

Primary Completion (Estimated)

July 31, 2026

Study Completion (Estimated)

July 31, 2026

Last Updated

April 28, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)