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RECRUITING

Development of a New Canadian Endourology Group Stent Symptom Score

NCT04909541 · View on ClinicalTrials.gov ↗

Study Summary

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 organizat

Conditions Studied

Interventions

  • OTHER CEGSSS-Canadian Endourology Group Stent Symptom Score

Study Locations (9)

Ontario

  • St. Michael's Hospital - University of Toronto — Toronto
  • Toronto General Hospital - University Health Network (UHN) — Toronto

Quebec

  • Centre Hospitalier de l'Université de Montréal (CHUM) — Montreal
  • Royal Victoria Hospital- McGill University Health Centre — Montreal

California

  • University of California, Los Angeles — Los Angeles

Ohio

  • Cleveland Clinic - University of Toronto. — Mayfield Heights

Alberta

  • Alberta University - Northern Alberta Urology Centre — Edmonton

British Columbia

  • Vancouver General Hospital — Vancouver

Nova Scottia

  • Dalhousie University — Halifax

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2022-05-15
Est. Completion 2025-09-15

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04909541

The ClinicalTrials.gov registry entry for NCT04909541 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Centre hospitalier de l'Université de Montréal (CHUM), which has 7 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Urologic Diseases appearing as the primary indexed condition, and to 1 intervention — of which CEGSSS-Canadian Endourology Group Stent Symptom Score is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04909541 reports 9 study locations spanning 7 distinct geographic areas — top geographies include Ontario, Quebec, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04909541 about?

NCT04909541 is a clinical study titled "Development of a New Canadian Endourology Group Stent Symptom Score". 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 associ...

What is the current status of trial NCT04909541?

This trial is currently recruiting. The enrollment target is 180 participants. The study started on 2022-05-15. Estimated completion is 2025-09-15.

What conditions does trial NCT04909541 study?

This clinical trial studies the following conditions: Urologic Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04909541?

The interventions under investigation include: CEGSSS-Canadian Endourology Group Stent Symptom Score (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04909541?

This trial is sponsored by Centre hospitalier de l'Université de Montréal (CHUM), which has 7 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04909541 being conducted?

This trial has 9 study locations across California, Ohio, Alberta, British Columbia, Nova Scottia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial