Creating a new symptom score for patients with ureteral stents
Canadian Endourology Group Stent Symptom Score: Development and Validation of A New Questionnaire
Centre hospitalier de l'Université de Montréal (CHUM) · NCT04909541
This study is trying to create a new symptom score to better understand how ureteral stents affect patients' quality of life.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 180 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre hospitalier de l'Université de Montréal (CHUM) (other) |
| Locations | 9 sites (Los Angeles, California and 8 other locations) |
| Trial ID | NCT04909541 on ClinicalTrials.gov |
What this trial studies
This observational study aims to develop a new symptom score specifically for patients with ureteral stents, addressing the limitations of existing questionnaires. The project is conducted in three phases, with the first two phases completed and the third phase pending ethics approval. The initial phases involve identifying and prioritizing the key symptoms and domains that should be included in the new Canadian Endourology Group Stent Symptom Score (CEGSSS) through a collaborative approach involving patients and experts. The goal is to create a validated tool that can effectively measure the quality of life impacts associated with ureteral stent placement.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older who currently have a ureteral stent and can communicate in English.
Not a fit: Patients with active malignancy, obstruction, or those who have had a long-term stent for more than two weeks may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective tool for assessing and improving the quality of life for patients with ureteral stents.
How similar studies have performed: While the approach of developing a new symptom score is not widely tested, the use of validated questionnaires in similar contexts has shown promise in improving patient outcomes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 18 years * Patient with ureteral stent * Ability to communicate in English Exclusion Criteria: * Inability to provide an informed consent due to physical or mental inability * Active malignancy * Obstruction * Long-term stent (\>2 weeks)
Where this trial is running
Los Angeles, California and 8 other locations
- University of California, Los Angeles — Los Angeles, California, United States (NOT_YET_RECRUITING)
- Cleveland Clinic - University of Toronto. — Mayfield Heights, Ohio, United States (NOT_YET_RECRUITING)
- Alberta University - Northern Alberta Urology Centre — Edmonton, Alberta, Canada (NOT_YET_RECRUITING)
- Vancouver General Hospital — Vancouver, British Columbia, Canada (RECRUITING)
- Dalhousie University — Halifax, Nova Scottia, Canada (NOT_YET_RECRUITING)
- St. Michael's Hospital - University of Toronto — Toronto, Ontario, Canada (NOT_YET_RECRUITING)
- Toronto General Hospital - University Health Network (UHN) — Toronto, Ontario, Canada (NOT_YET_RECRUITING)
- Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal, Quebec, Canada (RECRUITING)
- Royal Victoria Hospital- McGill University Health Centre — Montreal, Quebec, Canada (NOT_YET_RECRUITING)
Study contacts
- Principal investigator: Naeem Bhojani, MD — Centre hospitalier de l'Université de Montréal (CHUM)
- Study coordinator: Naeem Bhojani, MD
- Email: naeem.bhojani@gmail.com
- Phone: 514-890-8000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Urologic Diseases