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RECRUITING
NCT04909541

Development of a New Canadian Endourology Group Stent Symptom Score

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

View on ClinicalTrials.gov

Summary

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.

Official title: Canadian Endourology Group Stent Symptom Score: Development and Validation of A New Questionnaire

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2022-05-15

Completion Date

2025-09-15

Last Updated

2024-06-07

Healthy Volunteers

No

Interventions

OTHER

CEGSSS-Canadian Endourology Group Stent Symptom Score

Patient with ureteral stent complete the Canadian Endourology Group Stent Symptom Score (CEGSSS)

Locations (9)

University of California, Los Angeles

Los Angeles, California, United States

Cleveland Clinic - University of Toronto.

Mayfield Heights, Ohio, United States

Alberta University - Northern Alberta Urology Centre

Edmonton, Alberta, Canada

Vancouver General Hospital

Vancouver, British Columbia, Canada

Dalhousie University

Halifax, Nova Scottia, Canada

St. Michael's Hospital - University of Toronto

Toronto, Ontario, Canada

Toronto General Hospital - University Health Network (UHN)

Toronto, Ontario, Canada

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Royal Victoria Hospital- McGill University Health Centre

Montreal, Quebec, Canada