An interventional study of Optimized Timing of Intravesical Lidocaine Gel and Calming Music During Procedure in Bladder Cancer, sponsored by Western University, Canada. Not yet recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-10-02.
Sponsored by Western University, Canada · Not applicable, Interventional, and Supportive care
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:
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:
Bladder cancer is one of the most common malignancies of the urinary tract, and many patients require frequent endoscopic procedures as part of diagnosis, treatment, and surveillance. Flexible cystoscopy and intravesical instillation are standard procedures but are often associated with patient discomfort, anxiety, and negative procedural experiences. Improving comfort during these procedures has the potential to increase patient satisfaction, reduce procedural avoidance, and improve adherence to follow-up care.
Rationale Although flexible cystoscopy is minimally invasive, it can cause pain, embarrassment, and significant anxiety. Standard strategies to improve patient comfort, such as intravesical anesthetic gel, are variably effective. Previous work suggests that environmental modifications (e.g., calming music, ambient lighting), behavioral strategies (e.g., distraction), and optimization of local anesthetic use may enhance the patient experience. However, rigorous randomized controlled data in the cystoscopy and bladder instillation setting are lacking.
This study will address this gap by systematically evaluating comfort-enhancing interventions during flexible cystoscopy and bladder instillation for bladder cancer patients.
Study Objectives The primary objective is to determine whether comfort interventions reduce patient-reported anxiety and pain during flexible cystoscopy and bladder instillation procedures.
Secondary objectives include:
Study Design This study includes both a randomized controlled trial (RCT) and an observational component.
Randomized Controlled Trial (Interventional Arm):
Participants will be randomly assigned to receive standard care or a comfort interventions, such as:
Outcomes will be assessed using validated questionnaires (e.g., visual analogue scales for pain and anxiety, standardized patient-reported outcome measures).
Observational Arm:
Parallel to the RCT, observational data will be collected from a cohort undergoing flexible cystoscopy or intravesical instillation under standard care conditions. This will allow comparison with historical and real-world data, provide additional context for generalizability, and help inform the feasibility of widespread adoption of interventions.
Participant Population Participants will include adults undergoing flexible cystoscopy or bladder instillation for bladder cancer. Eligibility is broad to maximize generalizability, with minimal exclusion criteria. Translation services and literacy supports will be offered to ensure equitable participation.
Study Procedures
Outcomes
Significance This study will generate high-quality evidence on practical, low-cost, and easily implementable interventions to improve the patient experience during routine urological procedures. Findings may inform best practice guidelines, enhance patient-centered care, and support broader adoption of comfort-enhancing strategies in cystoscopy services.
1,616 studies on the registry are indexed under Urinary Bladder Neoplasms; 421 are open to participants now.
This study's planned enrollment of 378 is above the median of 60 across 1,163 interventional studies indexed under Urinary Bladder Neoplasms.
Browse Urinary Bladder Neoplasms studies →Western University, Canada is the lead sponsor of 221 studies on the registry; 56 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Individuals \<18 years of age.
Usual flexible cystoscopy or intravesical instillation under routine clinic conditions. Local anesthetic gel used per usual practice; no added comfort intervention.
2% lidocaine uro-gel instilled before and after procedure to maximize mucosal anesthesia.
Other: Optimized Timing of Intravesical Lidocaine Gel
Patients listen to a standardized calming playlist via headphones during the procedure.
Behavioral: Calming Music During Procedure
Patients view standardized visual content on a tablet/monitor positioned for comfort-focused distraction.
Behavioral: Visual Distraction with Screen Content
Procedure performed under standardized calming ambient lighting (blue-hue) per protocol.
Other: Calming Ambient Lighting
At the end of the procedure the flexible cystoscope is deliberately left in the bladder for 2 minutes, without manipulation, to reduce intensity/discomfort, based on the psychological principle of the "peak-end rule," aiming to improve overall remembered experience of the procedure.
Behavioral: Peak-End Modification of Procedure
Procedural modification of intravesical anesthetic gel administration. Lidocaine gel is instilled before and after flexible cystoscopy or bladder instillation to optimize mucosal anesthesia. This differs from standard practice where timing is not standardized - usually just before flexible cystoscopy.
Also known as: Anesthetic Gel Timing Modification, Lidocaine Gel Administration Interval
Participants listen to a standardized playlist of calming instrumental music delivered through headphones during the procedure. Intervention is intended to reduce procedural anxiety and discomfort.
Also known as: Relaxing Music, Music Therapy
Participants watch standardized visual content (e.g., relaxing video) on a screen or tablet during cystoscopy or bladder instillation. Designed to distract attention and enhance comfort.
Also known as: Video Distraction, Screen Viewing
Flexible cystoscopy or intravesical instillation performed under standardized calming ambient lighting (blue-hue) instead of standard clinical lighting. Intervention aims to promote relaxation and reduce anxiety.
Also known as: Lighting Modification
Modification of the procedural ending based on the psychological "peak-end rule." The end of the cystoscopy or instillation is deliberately altered to reduce final discomfort, aiming to improve overall remembered patient experience.
Also known as: Peak-End Rule Adjustment
Patient-reported Anxiety (VAS 0-100)
Anxiety level reported by participants immediately following flexible cystoscopy or bladder instillation, measured on a 0-100 visual analogue scale (0 = no anxiety, 100 = worst possible anxiety).
Time frame: Before and immediately after the procedure (within 30 minutes).
Patient-reported Anxiety (VAS 0-100)
Pain/discomfort reported by participants immediately following flexible cystoscopy or bladder instillation, measured on a 0-100 visual analogue scale (0 = no pain, 100 = worst possible pain).
Time frame: Immediately after the procedure (within 30 minutes).
Change in Anxiety from Baseline (VAS 0-100)
Difference in anxiety score from pre-procedure to post-procedure, measured using the 0-100 visual analogue scale.
Time frame: Before and immediately after procedure (within 30 minutes).
Baseline Anxiety (GAD-7 Score)
Participant baseline anxiety assessed using the Generalized Anxiety Disorder 7-item (GAD-7) questionnaire. Each item is scored 0-3; total score ranges 0-21, with higher scores indicating greater baseline anxiety.
Time frame: At baseline (pre-procedure, prior to randomization).
Patient Satisfaction (Survey-based)
Patient-reported satisfaction with procedure experience, measured using a structured post-procedure survey (includes overall satisfaction, willingness to repeat, perceived helpfulness of interventions, comparison to expectations, likelihood to recommend, and post-procedure symptoms).
Time frame: Immediately post-procedure and within 24 hours.
Quality of Life (EORTC QLQ-C30 Global Health Status)
Patient-reported quality of life assessed using the European Organisation for Research and Treatment of Cancer QLQ-C30 questionnaire. Includes global health status and functional scales (0-100).
Time frame: Prior to procedure
Plan to share: Yes — De-identified individual participant data (IPD) underlying the primary results will be made available to researchers upon reasonable request, beginning 12 months after publication. Requests will require a methodologically sound proposal and approval by the study steering committee. Data will be shared via secure transfer after execution of a data use agreement.
Supporting information: Study protocol, Sap
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Western University, Canada