About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 years
Patient with ureteral stent
Ability to communicate in English
Disqualifiers
Inability to provide an informed consent due to physical or mental inability
Active malignancy
Obstruction
Long-term stent (>2 weeks)
Trial population
Patient with ureteral stent
Trial design
Case-only
Prospective
Treatments tested in this trial
CEGSSS-Canadian Endourology Group Stent Symptom Score
Other interventionPatient with ureteral stent complete the Canadian Endourology Group Stent Symptom Score (CEGSSS)
Treatment groups
Trial outcomes
Primary outcomes
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
Home made survey about usability and acceptability
Assessment of usability and acceptability of the questionnaire among patients using the CEGSSS survey
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 α), test retest reliability (calculation of intraclass coefficient), factor loadings, eigenvalues and explained variance of the construct
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 α), test retest reliability (calculation of intraclass coefficient), factor loadings, eigenvalues and explained variance of the construct
Sponsors and contacts
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Centre hospitalier de l'Université de Montréal (CHUM)
Lead sponsor
Université de Montréal
Collaborator
University of British Columbia
Collaborator
University of Toronto
Collaborator
Dalhousie University
Collaborator
University of Alberta
Collaborator
McGill University
Collaborator
University of California, Los Angeles
Collaborator
University Health Network, Toronto
Collaborator