Development of a New Canadian Endourology Group Stent Symptom Score

NCT04909541 | Recruiting

• 1 other identifier: 21.398
• Study Type: observational
• Target: 180
• Locations: 2 countries
• Sites: 9

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

Conditions

Urologic Diseases

Outcome Measures

Primary Outcomes (5)

• Likert scale rating

  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

  through study completion, an average of 1 year

• Home made survey about usability and acceptability

  Assessment of usability and acceptability of the questionnaire among patients using the CEGSSS survey

  through study completion, an average of 18 months

• Canadian Endourology Group Stent Symptom Score (CEGSSS)

  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

  At baseline (after stent placement)

• Canadian Endourology Group Stent Symptom Score (CEGSSS)

  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

  At follow-up (7 days after stent placement and before stent removal)

• Ureteral stent symptom questionnaire (USSQ)

  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

  At follow-up (7 days after stent placement and before stent removal)

Study Arms (1)

Patient with ureteral stent

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

Other: CEGSSS-Canadian Endourology Group Stent Symptom Score

Interventions

CEGSSS-Canadian Endourology Group Stent Symptom Score OTHER

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

Patient with ureteral stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient with ureteral stent

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Université de Montréal: collaborator
• University of British Columbia: collaborator
• University of Toronto: collaborator
• Dalhousie University: collaborator
• University of Alberta: collaborator
• McGill University: collaborator
• University of California, Los Angeles: collaborator
• University Health Network, Toronto: collaborator

Study Sites (9)

University of California, Los Angeles

Los Angeles, California, 90095, United States

NOT YET RECRUITING

Cleveland Clinic - University of Toronto.

Mayfield Heights, Ohio, 44124, United States

NOT YET RECRUITING

Alberta University - Northern Alberta Urology Centre

Edmonton, Alberta, T6G 1Z1, Canada

NOT YET RECRUITING

Vancouver General Hospital

Vancouver, British Columbia, V6X 1Z9, Canada

RECRUITING

Dalhousie University

Halifax, Nova Scottia, B3H 1Y6, Canada

NOT YET RECRUITING

St. Michael's Hospital - University of Toronto

Toronto, Ontario, M5B 1W8, Canada

NOT YET RECRUITING

Toronto General Hospital - University Health Network (UHN)

Toronto, Ontario, M5G 2C4, Canada

NOT YET RECRUITING

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

RECRUITING

Royal Victoria Hospital- McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

NOT YET RECRUITING

Related Publications (1)

• Joshi HB, Newns N, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG. Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure. J Urol. 2003 Mar;169(3):1060-4. doi: 10.1097/01.ju.0000049198.53424.1d.

  PMID: 12576846 BACKGROUND

MeSH Terms

Conditions

Urologic Diseases

Condition Hierarchy (Ancestors)

Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Naeem Bhojani, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Naeem Bhojani, MD

CONTACT

514-890-8000; naeem.bhojani@gmail.com

Kahina Bensaadi, DESS

CONTACT

514-890-8000; kahina.bensaadi.chum@ssss.gouv.qc.ca

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2021
• First Posted: June 1, 2021
• Study Start: May 15, 2022
• Primary Completion: March 15, 2025
• Study Completion: September 15, 2025
• Last Updated: June 7, 2024

Record last verified: 2024-06

Locations

CA (7); US (2)