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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NCT04909541

Development of a New Canadian Endourology Group Stent Symptom Score

UNKNOWN
Not specifiedAges 18+Observational
Centre hospitalier de l'Université de Montréal (CHUM)
~180 participants
Updated 2024-06-07 on ClinicalTrials.gov
What's tested:CEGSSS-Canadian Endourology Group Stent Symptom Score

At a glance

Recruiting sites
2 of 9 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Likert scale rating
Measured over through study completion, an average of 1 year
+4 more outcomes measured
Urologic Diseases

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.

  • Naeem Bhojani, MD · PRINCIPAL_INVESTIGATOR · Centre hospitalier de l'Université de Montréal (CHUM)

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Eligibility criteria

Inclusion

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

Exclusion

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