Development of a New Canadian Endourology Group Stent Symptom Score

Part of paid clinical trials in Los Angeles, California.

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Study ID
NCT04909541
Status
Recruiting
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Conditions

  • Urologic Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CEGSSS-Canadian Endourology Group Stent Symptom Score — OTHER
    Patient with ureteral stent complete the Canadian Endourology Group Stent Symptom Score (CEGSSS)

Study Details

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 Dates

Start date
May 15, 2022
Status verified
Jun 2024
Primary completion
Mar 15, 2025
Completion
Sep 15, 2025

Study Design

Enrollment
180 participants (estimated)

Arms

  • Arm: Patient with ureteral stent
    Patients with ureteral stent that meet the inclusion, exclusion criteria complete the Canadian Endourology Group Stent Symptom Score (CEGSSS)

Primary Outcome Measure

Likert scale rating [ Time Frame: through study completion, an average of 1 year ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of California, Los AngelesLos AngelesCalifornia90095
Kymora Scotland, MD
[email protected]
Cleveland Clinic - University of Toronto.Mayfield HeightsOhio44124
Sri Sivalingham, MD
[email protected]

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