Development of a New Canadian Endourology Group Stent Symptom Score

Status unconfirmed

Conditions studied: Urologic Diseases

In brief

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.

Key facts

Study ID: NCT04909541
Run by: Centre hospitalier de l'Université de Montréal (CHUM)
People needed: 180
Starts: 2022-05-15
Expected to finish: 2025-09-15
Last updated by the study team: 2024-06-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Age ≥ 18 years
Patient with ureteral stent
Ability to communicate in English

You may not qualify if…

Inability to provide an informed consent due to physical or mental inability
Active malignancy
Obstruction
Long-term stent (>2 weeks)

Where it is running

Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada (enrolling)
Vancouver General Hospital — Vancouver, British Columbia, Canada (enrolling)
Alberta University - Northern Alberta Urology Centre — Edmonton, Alberta, 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
University of California, Los Angeles — Los Angeles, California, United States
Royal Victoria Hospital- McGill University Health Centre — Montreal, Quebec, Canada
Cleveland Clinic - University of Toronto. — Mayfield Heights, Ohio, United States

Full record on ClinicalTrials.gov

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