NCT04909541: CEGSSS

Development of a New Canadian Endourology Group Stent Symptom Score

Recruiting now Last updated 7 June 2024

What this trial tests

trial testing CEGSSS-Canadian Endourology Group Stent Symptom Score in Urologic Diseases in 180 participants. Currently enrolling.

Timeline

15 May 2022

Primary endpoint
15 March 2025

15 September 2025

Quick facts

Lead sponsor	Centre hospitalier de l'Université de Montréal (CHUM)
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	180
Start date	15 May 2022
Primary completion	15 March 2025
Estimated completion	15 September 2025
Sites	9 locations across Canada, United States

Drugs / interventions tested

• CEGSSS-Canadian Endourology Group Stent Symptom Score

Conditions studied

• Urologic Diseases — all drugs for Urologic Diseases →

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Who can join

18 and older, any sex, with Urologic Diseases. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.