Recruiting

Endourology Stent Score

Sponsor:

Centre hospitalier de l'Université de Montréal (CHUM)

Code:

NCT04909541

Conditions

Urologic Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CEGSSS-Canadian Endourology Group Stent Symptom Score

Study Details

Brief 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 organization dedicated to enabling the profession to provide the highest possible standards of endourological care and to advance the science of endourology by collaboratively:

1. Fostering excellence in endourological practice through advocacy, education, research and practice support tools,
2. Leading evidence-based clinical practice through the development of practice standards and guidelines in endourology,
3. Providing continuous professional development for Canadian endourologists along the career-path continuum,
4. Providing leadership in public education for endourological conditions.

Conditions

Urologic Diseases

Study ID

NCT04909541

Start date

May 15, 2022

Status verified date

Jun, 2024

Completion date

Sep 15, 2025

Anticipated

Primary completion date

Mar 15, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

180 participants

Anticipated

Interventions and Outcome Measures

Arms

Patient with ureteral stent

Patients with ureteral stent that meet the inclusion, exclusion criteria complete the Canadian Endourology Group Stent Symptom Score (CEGSSS)

Interventions

CEGSSS-Canadian Endourology Group Stent Symptom Score

Patient with ureteral stent complete the Canadian Endourology Group Stent Symptom Score (CEGSSS)

Primary outcome measure

  • Likert scale rating [ Time Frame: through study completion, an average of 1 year ]
  • Home made survey about usability and acceptability [ Time Frame: through study completion, an average of 18 months ]
  • Canadian Endourology Group Stent Symptom Score (CEGSSS) [ Time Frame: At baseline (after stent placement) ]
  • Canadian Endourology Group Stent Symptom Score (CEGSSS) [ Time Frame: At follow-up (7 days after stent placement and before stent removal) ]
  • Ureteral stent symptom questionnaire (USSQ) [ Time Frame: At follow-up (7 days after stent placement and before stent removal) ]

Central Contacts and Locations

Locations

Vancouver General Hospital

Recruiting

Vancouver, British Columbia, Canada, V6X 1Z9

Contacts

Centre Hospitalier de l'Université de Montréal (CHUM)

Recruiting

Montréal, Quebec, Canada, H2X 3E4

Contacts

More Information

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Last update posted

Jun 7, 2024

Last verified

Jun, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Centre hospitalier de l'Université de Montréal (CHUM) on 2024-06-07.