Urologic Diseases Clinical Trial
— CEGSSSOfficial title:
Canadian Endourology Group Stent Symptom Score: Development and Validation of A New Questionnaire
NCT number | NCT04909541 |
Other study ID # | 21.398 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | May 15, 2022 |
Est. completion date | September 15, 2025 |
Placement of a ureteral stent is a common urological intervention. For decades there was no valid measures available to assess quality of life issues in patients with ureteral stents, which has hampered the understanding of such symptoms and their true impact. In order to improve the outcomes associated with the placement of a stent, a validated tool is needed to measure its impact and the amount of undesirable effects it produces on patients requiring the placement of a stent. In 2003, the team of the Bristol Urological Institute developed a validated questionnaire called the: URETERAL STENT SYMPTOM QUESTIONNAIRE (USSQ). The questionnaire contains 38 items included in 6 sections. Despite the obvious need of a validated questionnaire, the latter remains unused by the community of peer urologists. Many of urologists consider it too long to be used in clinical practice and even for research purposes. This issue motivated the Canadian Endourology Group (CEG) to work collaboratively on the development of the CANADIAN ENDOUROLOGY GROUP STENT SYMPTOM SCORE (CEGSSS) in order to provide clinicians with a more useful and validated tool. To fulfill this objective, the CEG proceeds in three phases. Phase 1. A systematic, deliberative, and participatory approach mostly through face to face meetings, including patients, clinicians, and researchers in the field of Endourology to identify a minimum needs-based set of domains and items that are, clinically relevant to be included in the CEGSSS in order to ensure optimal uptake in the clinical setting. Phase 2. A pilot study to assess feasibility/acceptability and further refine the proposed set of items selected in phase 1 of the study. Phase 3. A multicentric prospective study to evaluate the validity, reliability and sensitivity to change of the CEGSSS. This research project is conducted by the Canadian Endourology Group (CEG), a panel of experts in the field of endourology in Canada. The CEG is a national member-based organization dedicated to enabling the profession to provide the highest possible standards of endourological care and to advance the science of endourology by collaboratively: 1. Fostering excellence in endourological practice through advocacy, education, research and practice support tools, 2. Leading evidence-based clinical practice through the development of practice standards and guidelines in endourology, 3. Providing continuous professional development for Canadian endourologists along the career-path continuum, 4. Providing leadership in public education for endourological conditions.
Status | Recruiting |
Enrollment | 180 |
Est. completion date | September 15, 2025 |
Est. primary completion date | March 15, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Age = 18 years - Patient with ureteral stent - Ability to communicate in English Exclusion Criteria: - Inability to provide an informed consent due to physical or mental inability - Active malignancy - Obstruction - Long-term stent (>2 weeks) |
Country | Name | City | State |
---|---|---|---|
Canada | Alberta University - Northern Alberta Urology Centre | Edmonton | Alberta |
Canada | Dalhousie University | Halifax | Nova Scottia |
Canada | Centre Hospitalier de l'Université de Montréal (CHUM) | Montréal | Quebec |
Canada | Royal Victoria Hospital- McGill University Health Centre | Montréal | Quebec |
Canada | St. Michael's Hospital - University of Toronto | Toronto | Ontario |
Canada | Toronto General Hospital - University Health Network (UHN) | Toronto | Ontario |
Canada | Vancouver General Hospital | Vancouver | British Columbia |
United States | University of California, Los Angeles | Los Angeles | California |
United States | Cleveland Clinic - University of Toronto. | Mayfield Heights | Ohio |
Lead Sponsor | Collaborator |
---|---|
Centre hospitalier de l'Université de Montréal (CHUM) | Dalhousie University, McGill University, Université de Montréal, University Health Network, Toronto, University of Alberta, University of British Columbia, University of California, Los Angeles, University of Toronto |
United States, Canada,
Joshi HB, Newns N, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG. Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure. J Urol. 2003 Mar;169(3):1060-4. doi: 10.1097/01.ju.0000049198.53424.1d. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Likert scale rating | Percentage of agreement on domains and items to be included in the CEGSSS is calculated based on the rating of each item using a Likert scale from 1 to 5. 5 being the highest level of rating regarding the clinical relevance and the necessity of inclusion of a given item | through study completion, an average of 1 year | |
Primary | Home made survey about usability and acceptability | Assessment of usability and acceptability of the questionnaire among patients using the CEGSSS survey | through study completion, an average of 18 months | |
Primary | Canadian Endourology Group Stent Symptom Score (CEGSSS) | The CEGSSS questionnaire will be administered to participants in order to measure, using the collected data, internal consistency (calculation of Cronbach's a), test retest reliability (calculation of intraclass coefficient), factor loadings, eigenvalues and explained variance of the construct | At baseline (after stent placement) | |
Primary | Canadian Endourology Group Stent Symptom Score (CEGSSS) | The CEGSSS questionnaire will be administered to participants in order to measure, using the collected data, internal consistency (calculation of Cronbach's a), test retest reliability (calculation of intraclass coefficient), factor loadings, eigenvalues and explained variance of the construct | At follow-up (7 days after stent placement and before stent removal) | |
Primary | Ureteral stent symptom questionnaire (USSQ) | The USSQ questionnaire will be administered to participants in order to measure, using the collected data, the correlation between the CEGSSS and the USSQ using Pearson correlation and Spearman rank correlation | At follow-up (7 days after stent placement and before stent removal) |
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