Development of a New Canadian Endourology Group Stent Symptom Score (CEGSSS)
This observational study is developing a new questionnaire, the Canadian Endourology Group Stent Symptom Score (CEGSSS), to better understand the impact of ureteral stents (small tubes placed in the urinary tract) on patients' quality of life. Currently, there isn't a good tool to measure these symptoms, which makes it hard to improve care for people with stents. This study aims to create a reliable tool by asking patients with ureteral stents to complete the CEGSSS. Researchers will look at how patients rate their symptoms using a Likert scale and how usable and acceptable the new survey is. You might be able to join if you are 18 or older, have a ureteral stent, can communicate in English, and do not have an active cancer, an obstruction, or a long-term stent (over 2 weeks). The study is currently in its third phase of development, with the first two phases completed.
- Study design
- This is an observational study with a planned enrollment of 180 participants. It is not a randomized or blinded study.
- What's involved
- Participants will complete the Canadian Endourology Group Stent Symptom Score (CEGSSS) at baseline (after stent placement). They will also complete a Likert scale rating and a home-made survey about usability and acceptability over an average of 1 to 1.5 years.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed through study completion, which is an average of 1 year for Likert scale ratings and 18 months for the usability and acceptability survey.
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Development of a New Canadian Endourology Group Stent Symptom Score
At a glance
Conditions
NCT04909541
Where you'd take part
This study runs at 9 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Alberta University - Northern Alberta Urology Centre
Edmonton, Alberta, Canadastudy coordinator listed
Not yet recruiting
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canadastudy coordinator listed
Recruiting
Cleveland Clinic - University of Toronto.
Mayfield Heights, Ohiostudy coordinator listed
Not yet recruiting
Dalhousie University
Halifax, Nova Scottia, Canadastudy coordinator listed
Not yet recruiting
Royal Victoria Hospital- McGill University Health Centre
Montreal, Quebec, Canadastudy coordinator listed
Not yet recruiting
St. Michael's Hospital - University of Toronto
Toronto, Ontario, Canadastudy coordinator listed
Not yet recruiting
Toronto General Hospital - University Health Network (UHN)
Toronto, Ontario, Canadastudy coordinator listed
Not yet recruiting
University of California, Los Angeles
Los Angeles, Californiastudy coordinator listed
Not yet recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Naeem Bhojani, MD · PRINCIPAL_INVESTIGATOR · Centre hospitalier de l'Université de Montréal (CHUM)
Who to contact
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Inclusion
Exclusion
What this trial measures
- Likert scale ratingthrough study completion, an average of 1 year
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 acceptabilitythrough study completion, an average of 18 months
Assessment of usability and acceptability of the questionnaire among patients using the CEGSSS survey
- Canadian Endourology Group Stent Symptom Score (CEGSSS)At baseline (after stent placement)
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)At follow-up (7 days after stent placement and before stent removal)
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
- Ureteral stent symptom questionnaire (USSQ)At follow-up (7 days after stent placement and before stent removal)
The USSQ questionnaire will be administered to participants in order to measure, using the collected data, the correlation between the CEGSSS and the USSQ using Pearson correlation and Spearman rank correlation