Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure.
H B Joshi, N Newns, A Stainthorpe...
https://pubmed.ncbi.nlm.nih.gov/12576846Actively Recruiting
Age: 18Years +
All Genders
ID04909541
Canadian Endourology Group Stent Symptom Score: Development and Validation of A New Questionnaire
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2024-06-07
180
Participants Needed
9
Research Sites
26 weeks
Total Duration
On this page
Sponsors
C
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
U
Université de Montréal
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are developing and validating a new questionnaire called the Canadian Endourology Group Stent Symptom Score (CEGSSS) to better assess quality of life issues in patients with ureteral stents. This study addresses the lack of a practical and validated tool to measure symptoms and impacts caused by ureteral stents, aiming to improve clinical care and research in this area. The project is led by the Canadian Endourology Group, a national organization focused on advancing endourological care and research. The study is conducted in three phases: Phase 1 identified important symptom domains and items through expert and patient consensus. Phase 2 tested the feasibility and acceptability of the questionnaire in patients with ureteral stents. Phase 3, currently under preparation, will be a multicenter prospective study involving approximately 180 patients to evaluate the validity, reliability, and sensitivity to change of the CEGSSS. Patients will complete the CEGSSS and the existing Ureteral Stent Symptom Questionnaire (USSQ) at baseline and follow-up visits. Participants will complete the CEGSSS questionnaire at various time points after stent insertion, including baseline and before stent removal. Researchers will assess the questionnaire's internal consistency, test-retest reliability, factor structure, and validity by comparing it to the USSQ. Data will be collected securely and analyzed to ensure the tool accurately measures patient symptoms and quality of life related to ureteral stents. The study involves no physical or psychological risks, and participation will not affect the care patients receive.
CONDITIONS
Brief Title
Development of a New Canadian Endourology Group Stent Symptom Score
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Patient currently has a ureteral stent
- Ability to communicate in English
You will not qualify if you...
- Unable to provide informed consent due to physical or mental disability
- Active malignancy
- Presence of obstruction
- Long-term stent expected to be in place for more than 2 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Monitoring
Duration - Approximately 7 to 14 days
Participants with a ureteral stent complete the Canadian Endourology Group Stent Symptom Score (CEGSSS) questionnaire to evaluate stent symptoms and provide feedback on the questionnaire's clarity and usability.
2 visits (in-person or remote) at 7 days and 14 days after stent insertion
Long-term Monitoring
Duration - Up to 18 months
Participants' responses to the questionnaire are analyzed to assess the validity, reliability, and sensitivity to change of the CEGSSS over the study period.
Follow-up assessments via questionnaires during the study period
Trial Site Locations
Total: 9 locations
1
University of California, Los Angeles
Los Angeles, California, United States, 90095
Not Yet Recruiting
2
Cleveland Clinic - University of Toronto.
Mayfield Heights, Ohio, United States, 44124
Not Yet Recruiting
3
Alberta University - Northern Alberta Urology Centre
Edmonton, Alberta, Canada, T6G 1Z1
Not Yet Recruiting
4
Vancouver General Hospital
Vancouver, British Columbia, Canada, V6X 1Z9
Actively Recruiting
5
Dalhousie University
Halifax, Nova Scottia, Canada, B3H 1Y6
Not Yet Recruiting
6
St. Michael's Hospital - University of Toronto
Toronto, Ontario, Canada, M5B 1W8
Not Yet Recruiting
7
Toronto General Hospital - University Health Network (UHN)
Toronto, Ontario, Canada, M5G 2C4
Not Yet Recruiting
8
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
9
Royal Victoria Hospital- McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Not Yet Recruiting
Loading map...
Research Team
N
Naeem Bhojani, MD
K
Kahina Bensaadi, DESS
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here
Published Research Related To This Trial
Development and Initial Validation of a New Stent Symptom Questionnaire for Short-Term Dwell Time: The Canadian Endourology Group Stent Symptom Score.
Naeem Bhojani, Sri Sivalingam, Kymora B Scotland...
https://pubmed.ncbi.nlm.nih.gov/41529175