- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07553884
Baseline Knowledge of Stress Urinary Incontinence Among Urogynecology Patients (SUI)
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:
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Aysha Nedham, MD, FRCSC
- Phone Number: 1-416-480-6100
- Email: aysha.nedham@sunnybrook.ca
Study Contact Backup
- Name: Razia Sultana, MD, PhD
- Email: Razia.sultana@sri.utoronto.ca
Study Locations
-
-
Onatrio
-
Toronto, Onatrio, Canada, M4N 3M5
- Sunnybrook Health Sciences Centre
-
Contact:
- Aysha Nedham, MD, BSc, FRCSC
- Phone Number: (416) 480-6100
- Email: aysha.nedham@sunnybrook.ca
-
Sub-Investigator:
- Aysha Nedham, MD, BSc, FRCSC
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
At the same clinic visit: from enrollment to completing the post-intervention SUI Knowledge questionnaire
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 3. Minassian VA, Drutz HP, Al-Badr A. Urinary incontinence as a worldwide problem. Int J Gynaecol Obstet. 2003;82(3):327-338.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urogenital Diseases
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urination Disorders
- Lower Urinary Tract Symptoms
- Urological Manifestations
- Urinary Incontinence
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Urinary Incontinence, Stress
Other Study ID Numbers
- 7119
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Stress Urinary Incontinence (SUI)
-
Shin Kong Wu Ho-Su Memorial HospitalCompletedFemale Stress Urinary Incontinence | Stress Urinary Incontinence (SUI)Taiwan
-
Procter and GambleCompletedStress Urinary Incontinence (SUI)United States
-
Lahore University of Biological and Applied SciencesActive, not recruitingStress Urinary Incontinence in Women | Stress Urinary Incontinence (SUI)Pakistan
-
Peking Union Medical College HospitalNot yet recruitingStress Urinary Incontinence (SUI)China
-
IRCCS San RaffaeleNot yet recruitingStress Urinary Incontinence (SUI)
-
Sanliurfa Education and Research HospitalActive, not recruitingStress Urinary Incontinence (SUI)Turkey (Türkiye)
-
Atlantic Health SystemCompletedStress Urinary Incontinence (SUI)United States
-
Ceragem Clinical Inc.RecruitingStress Urinary Incontinence (SUI)South Korea
-
Lahore University of Biological and Applied SciencesActive, not recruitingStress Urinary Incontinence (SUI)Pakistan
-
Ain Shams UniversityNot yet recruiting
Clinical Trials on 15 Item Questionnaire
-
M.D. Anderson Cancer CenterSigma Theta Tau InternationalActive, not recruiting
-
Chinese University of Hong KongCompletedBenign Prostatic Hyperplasia (BPH)Hong Kong
-
Brugmann University HospitalCompletedSarcopenia | Old Age; Debility | SensitivityBelgium
-
Memorial Sloan Kettering Cancer CenterM.D. Anderson Cancer Center; University of California, Los Angeles; Icahn School... and other collaboratorsActive, not recruitingRenal CancerUnited States
-
Massachusetts General HospitalShriners Hospitals for ChildrenCompleted
-
University Hospital, Strasbourg, FranceCompletedSurgical Intervention | MinorFrance
-
University Hospital, AngersCompletedPostoperative RecoveryFrance
-
Saglik Bilimleri Universitesi Gulhane Tip FakultesiRecruitingQuality of Life | Postoperative Complications | Surgery | AnesthesiaTurkey
-
University Hospital, AngersNot yet recruitingPostoperative Complications | Surgery | Anesthesia | Patient Reported Outcome Measures | Quality of Recovery | Perioperative Complication | Emergency Surgery
-
Federico II UniversityCompletedCOVID | Psychological Distress | Severe Mental DisorderItaly