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

Western University, Canada

Status: Not yet enrolling

Conditions: Bladder Cancer

Treatments: Behavioral: Visual Distraction with Screen Content; Behavioral: Calming Music During Procedure; Behavioral: Peak-End Modification of Procedure; Other: Optimized Timing of Intravesical Lidocaine Gel; Other: Calming Ambient Lighting

Study type: Interventional

Funder types: Other

Identifiers

NCT07204301

16395

Details and patient eligibility

About

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

Full description

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:

• To assess whether these interventions improve overall patient satisfaction.
• To determine whether these interventions influence willingness to undergo repeat procedures.
• To explore procedural efficiency, clinician satisfaction, and feasibility of implementing these interventions in routine care.

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:

• Optimized timing of intravesical anesthetic gel
• Calming background music
• Visual distraction or environmental modifications
• Ambient lighting changes

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

• All participants will undergo flexible cystoscopy or intravesical instillation as clinically indicated.
• RCT participants will be randomized to intervention vs. standard care groups.
• Participants will complete short questionnaires before, during, and after the procedure assessing comfort, pain, and anxiety.
• Follow-up will include willingness to undergo repeat procedures and satisfaction ratings.

Outcomes

• Primary outcomes: Patient-reported pain and anxiety scores.
• Secondary outcomes: Overall satisfaction, willingness to repeat procedure, efficiency measures, and clinician feedback.

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.

Enrollment: 378 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

Individuals <18 years of age.

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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378 participants in 6 patient groups

No Intervention

No Intervention group

Description:

Usual flexible cystoscopy or intravesical instillation under routine clinic conditions. Local anesthetic gel used per usual practice; no added comfort intervention.

Optimized Anesthetic Gel Timing

Experimental group

Description:

2% lidocaine uro-gel instilled before and after procedure to maximize mucosal anesthesia.

Treatment:

Other: Optimized Timing of Intravesical Lidocaine Gel

Calming Music

Experimental group

Description:

Patients listen to a standardized calming playlist via headphones during the procedure.

Treatment:

Behavioral: Calming Music During Procedure

Visual Distraction

Experimental group

Description:

Patients view standardized visual content on a tablet/monitor positioned for comfort-focused distraction.

Treatment:

Behavioral: Visual Distraction with Screen Content

Ambient Lighting

Experimental group

Description:

Procedure performed under standardized calming ambient lighting (blue-hue) per protocol.

Treatment:

Other: Calming Ambient Lighting

Peak-End Modification

Experimental group

Description:

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.

Treatment:

Behavioral: Peak-End Modification of Procedure