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NCT07204301Not yet recruiting

Enhancing Patient Comfort and Reducing Anxiety During Flexible Cystoscopy and Bladder Instillation in Bladder Cancer Patients: A Randomized Controlled Trial and Observational Study

Source: ClinicalTrials.gov · Last updated 2 Oct 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The goal of this clinical trial is to learn if certain comfort-enhancing interventions can reduce pain and anxiety during flexible cystoscopy and bladder instillation in patients with bladder cancer. The main questions it aims to answer are: * Do these interventions reduce patient-reported anxiety during the procedure? * Do these interventions reduce patient-reported pain or discomfort during the procedure? Researchers will compare patients receiving comfort interventions (such as timing of anesthetic gel, calming music, or visual distraction) to those receiving standard care to see if these changes improve patient experience. Participants will: * Undergo a flexible cystoscopy or bladder instillation as part of their usual care * Be randomly assigned to receive one or more comfort interventions, or standard care * Complete short questionnaires about their pain, comfort, and anxiety

Status (registry)
Not yet recruiting
Study type
Interventional
Enrollment
378 (estimated)
First submitted
24 Sept 2025
Start date
1 Nov 2025
Primary completion date
1 Jul 2026
Lead sponsor
Western University, Canada
NCT number
NCT07204301

What you commit to

  • Study type: Interventional
  • Planned participants: 378
  • From 1 Nov 2025 to the primary completion date, 1 Jul 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Individuals unable to communicate verbally with study staff (e.g., severe speech/hearing impairment without assistive support available).
  • Individuals with severe cognitive impairment or acute distress at the time of approach that prevents informed consent.
  • Individuals with known hypersensitivity or allergy to lidocaine, topical anesthetic gel, or any components used in the procedure.

Age

  • Individuals \<18 years of age.

Other

  • Individuals unable to provide informed consent (e.g., diminished or fluctuating capacity).
  • Individuals for whom, in the opinion of the treating urologist, participation would pose undue clinical risk or interfere with urgent clinical care.

Who the study is looking for

  • Age ≥ 18 years
  • Diagnosis of bladder cancer undergoing diagnostic/surveillance flexible cystoscopy or intravesical bladder instillation in the outpatient urology clinic
  • Able to provide informed consent

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Victoria Hospital - London Health Sciences Center
Coordinator of this site? Confirm its status
LondonCanadaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.