Stress Urinary Incontinence (SUI)SUINCT07553884
Baseline Knowledge of Stress Urinary Incontinence Among Urogynecology Patients
An observational study of Stress Urinary Incontinence (SUI), run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Stress Urinary Incontinence (SUI)
- What is being tested?
- 15 Item Questionnaire
- How many people
- 90 participants
- Where
- 1 siteCanada
- Study dates
- 30 Apr 2026to 31 Jul 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Population will be new patients referred to Urogynecology clinic at Sunnybrook Health Sciences Centre with clinical presentation of SUI
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Razia Sultana, MD, PhD contact
Canada1 site
Sunnybrook Health Sciences Centre
Toronto, Onatrio, M4N 3M5
Aysha Nedham, MD, BSc, FRCSC, (416) 480-6100, aysha.nedham@sunnybrook.ca
Aysha Nedham, MD, BSc, FRCSC
About this study
Official title: Knowledge, Awareness, and Understanding of Stress Urinary Incontinence in Patients Attending a Urogynecology Clinic
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:
Read more
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.
Read the 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.
- Conditions
- Stress Urinary Incontinence (SUI)
- Being tested
- 15 Item Questionnaire
- Keywords
- prospective cohort
- Medical subject headings
- Urinary Incontinence, Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: 15 Item Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At the same clinic visit: from enrollment to completing the post-intervention SUI Knowledge questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2026
- Study start30 Apr 2026 (estimated)
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Stress Urinary Incontinence (SUI)Studies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Patricia Lee, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07553884
- Sponsor's protocol ID
- 7119
- Acronym
- SUI
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 28 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Shaw C, Tansey R, Jackson C, Hyde C, Allan R. Barriers to help seeking in people with urinary symptoms. Fam Pract. 2001 Feb;18(1):48-52. doi: 10.1093/fampra/18.1.48.
PubMed 11145628Kinchen 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 (Larchmt). 2003 Sep;12(7):687-98. doi: 10.1089/154099903322404339.
PubMed 14583109Shaw C, Gupta RD, Bushnell DM, Assassa RP, Abrams P, Wagg A, Mayne C, Hardwick C, Martin M. The extent and severity of urinary incontinence amongst women in UK GP waiting rooms. Fam Pract. 2006 Oct;23(5):497-506. doi: 10.1093/fampra/cml033. Epub 2006 Jul 13.
PubMed 16840498Coyne KS, Wein A, Nicholson S, Kvasz M, Chen CI, Milsom I. Comorbidities and personal burden of urgency urinary incontinence: a systematic review. Int J Clin Pract. 2013 Oct;67(10):1015-33. doi: 10.1111/ijcp.12164.
PubMed 24073974Subak LL, Brown JS, Kraus SR, Brubaker L, Lin F, Richter HE, Bradley CS, Grady D; Diagnostic Aspects of Incontinence Study Group. The "costs" of urinary incontinence for women. Obstet Gynecol. 2006 Apr;107(4):908-16. doi: 10.1097/01.AOG.0000206213.48334.09.
PubMed 16582131Hannestad YS, Rortveit G, Sandvik H, Hunskaar S; Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trondelag. A community-based epidemiological survey of female urinary incontinence: the Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trondelag. J Clin Epidemiol. 2000 Nov;53(11):1150-7. doi: 10.1016/s0895-4356(00)00232-8.
PubMed 111068895. 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.
Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
PubMed 11857671Minassian VA, Drutz HP, Al-Badr A. Urinary incontinence as a worldwide problem. Int J Gynaecol Obstet. 2003 Sep;82(3):327-38. doi: 10.1016/s0020-7292(03)00220-0.
PubMed 14499979Wu JM, Vaughan CP, Goode PS, Redden DT, Burgio KL, Richter HE, Markland AD. Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol. 2014 Jan;123(1):141-148. doi: 10.1097/AOG.0000000000000057.
PubMed 24463674Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.11.1311.
PubMed 18799443
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Knowledge, Awareness, and Understanding of Stress Urinary Incontinence in Patients Attending a Urogynecology Clinic
- ClinicalTrials.gov ID
- NCT07553884
- Acronym / sponsor ID
- SUI / 7119
- Conditions
- Stress Urinary Incontinence (SUI)
- Keywords
- prospective cohort
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- 30 Apr 2026 (estimated)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 28 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All participants receive the same intervention and complete the same questionnaire | – | Other: 15 Item QuestionnaireConsenting 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Population will be new patients referred to Urogynecology clinic at Sunnybrook Health Sciences Centre with clinical presentation of SUI
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 15 Item QuestionnaireParticipants 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. | Other | All participants receive the same intervention and complete the same questionnaire |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2026.
- Background: PubMed 11145628Shaw C, Tansey R, Jackson C, Hyde C, Allan R. Barriers to help seeking in people with urinary symptoms. Fam Pract. 2001 Feb;18(1):48-52. doi: 10.1093/fampra/18.1.48.
- Background: PubMed 14583109Kinchen 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 (Larchmt). 2003 Sep;12(7):687-98. doi: 10.1089/154099903322404339.
- Background: PubMed 16840498Shaw C, Gupta RD, Bushnell DM, Assassa RP, Abrams P, Wagg A, Mayne C, Hardwick C, Martin M. The extent and severity of urinary incontinence amongst women in UK GP waiting rooms. Fam Pract. 2006 Oct;23(5):497-506. doi: 10.1093/fampra/cml033. Epub 2006 Jul 13.
- Background: PubMed 24073974Coyne KS, Wein A, Nicholson S, Kvasz M, Chen CI, Milsom I. Comorbidities and personal burden of urgency urinary incontinence: a systematic review. Int J Clin Pract. 2013 Oct;67(10):1015-33. doi: 10.1111/ijcp.12164.
- Background: PubMed 16582131Subak LL, Brown JS, Kraus SR, Brubaker L, Lin F, Richter HE, Bradley CS, Grady D; Diagnostic Aspects of Incontinence Study Group. The "costs" of urinary incontinence for women. Obstet Gynecol. 2006 Apr;107(4):908-16. doi: 10.1097/01.AOG.0000206213.48334.09.
- Background: PubMed 11106889Hannestad YS, Rortveit G, Sandvik H, Hunskaar S; Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trondelag. A community-based epidemiological survey of female urinary incontinence: the Norwegian EPINCONT study. Epidemiology of Incontinence in the County of Nord-Trondelag. J Clin Epidemiol. 2000 Nov;53(11):1150-7. doi: 10.1016/s0895-4356(00)00232-8.
- Background5. 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: PubMed 11857671Abrams P, Cardozo L, Fall M, Griffiths D, Rosier P, Ulmsten U, van Kerrebroeck P, Victor A, Wein A; Standardisation Sub-committee of the International Continence Society. The standardisation of terminology of lower urinary tract function: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn. 2002;21(2):167-78. doi: 10.1002/nau.10052. No abstract available.
- Background: PubMed 14499979Minassian VA, Drutz HP, Al-Badr A. Urinary incontinence as a worldwide problem. Int J Gynaecol Obstet. 2003 Sep;82(3):327-38. doi: 10.1016/s0020-7292(03)00220-0.
- Background: PubMed 24463674Wu JM, Vaughan CP, Goode PS, Redden DT, Burgio KL, Richter HE, Markland AD. Prevalence and trends of symptomatic pelvic floor disorders in U.S. women. Obstet Gynecol. 2014 Jan;123(1):141-148. doi: 10.1097/AOG.0000000000000057.
- Background: PubMed 18799443Nygaard I, Barber MD, Burgio KL, Kenton K, Meikle S, Schaffer J, Spino C, Whitehead WE, Wu J, Brody DJ; Pelvic Floor Disorders Network. Prevalence of symptomatic pelvic floor disorders in US women. JAMA. 2008 Sep 17;300(11):1311-6. doi: 10.1001/jama.300.11.1311.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Razia Sultana, MD, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stress Urinary Incontinence (SUI), run by Sunnybrook Health Sciences Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aysha Nedham, MD, FRCSC (1-416-480-6100, aysha.nedham@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07553884, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.