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Bladder CancerFlexi-comfortNCT07204301

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

A study testing Optimized Timing of Intravesical Lidocaine Gel, Calming Music During Procedure and Visual Distraction with Screen Content in people with Bladder Cancer, run by Western University, Canada at 1 site in Canada.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bladder Cancer
What is being tested?
Optimized Timing of Intravesical Lidocaine Gel, Calming Music During Procedure and Visual Distraction with Screen Content
Could I receive a placebo?
No, everyone receives an active treatment
How many people
378 participants
Where
1 siteCanada
Study dates
1 Nov 2025to 1 Jul 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Canada1 site
  • Victoria Hospital - London Health Sciences Center

    London, Ontario, N6A 5W9

    Kaydee Connors, 519-685-8500 ext. 56366, kaydee.connors@lhsc.on.ca

    Lorraine Scanlon, MD

Other trials in Canada

About this study

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?
Read more

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
Read the detailed 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.

Conditions
Bladder Cancer
Being tested
Optimized Timing of Intravesical Lidocaine Gel, Calming Music During Procedure, Visual Distraction with Screen Content, Calming Ambient Lighting, Peak-End Modification of Procedure
Keywords
flexible cystoscopy, bladder instillation, Patient comfort, Anxiety reduction, Pain management, Urologic oncology, Bladder cancer surveillance, Patient-reported outcomes, Procedural anxiety, Minimally invasive urology
Medical subject headings
Urinary Bladder Neoplasms, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Optimized Timing of Intravesical Lidocaine GelOther

    Also called Anesthetic Gel Timing Modification, Lidocaine Gel Administration Interval

    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.

  • Calming Music During ProcedureBehavioural

    Also called Relaxing Music, Music Therapy

    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.

  • Visual Distraction with Screen ContentBehavioural

    Also called Video Distraction, Screen Viewing

    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.

  • Calming Ambient LightingOther

    Also called Lighting Modification

    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.

  • Peak-End Modification of ProcedureBehavioural

    Also called Peak-End Rule Adjustment

    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.

Study groups in NCT07204301
Study groupRoleWhat they receive
No InterventionNo interventionUsual flexible cystoscopy or intravesical instillation under routine clinic conditions. Local anesthetic gel used per usual practice; no added comfort intervention.
Optimized Anesthetic Gel TimingExperimental2% lidocaine uro-gel instilled before and after procedure to maximize mucosal anesthesia.
Receives: Other: Optimized Timing of Intravesical Lidocaine Gel
Calming MusicExperimentalPatients listen to a standardized calming playlist via headphones during the procedure.
Receives: Behavioral: Calming Music During Procedure
Visual DistractionExperimentalPatients view standardized visual content on a tablet/monitor positioned for comfort-focused distraction.
Receives: Behavioral: Visual Distraction with Screen Content
Ambient LightingExperimentalProcedure performed under standardized calming ambient lighting (blue-hue) per protocol.
Receives: Other: Calming Ambient Lighting
Peak-End ModificationExperimentalAt 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.
Receives: Behavioral: Peak-End Modification of Procedure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Before and immediately after the procedure (within 30 minutes).

  2. 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).

    Measured: Immediately after the procedure (within 30 minutes).

Secondary outcomes (4)
  1. 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.

    Measured: Before and immediately after procedure (within 30 minutes).

  2. 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.

    Measured: At baseline (pre-procedure, prior to randomization).

  3. 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).

    Measured: Immediately post-procedure and within 24 hours.

  4. 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).

    Measured: Prior to procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2025
  2. Study start1 Nov 2025 (estimated)
  3. Primary completion1 Jul 2026 (estimated)
  4. Study completion1 Jul 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants will be randomly assigned in a parallel fashion to either standard care or comfort-enhancing interventions during flexible cystoscopy or intravesical instillation. Each participant will remain in their assigned group for the duration of the study, and outcomes will be compared between groups. The interventions include practical, non-pharmacologic strategies (e.g., optimized timing of anesthetic gel, calming music, visual distraction, or ambient lighting changes) that can be readily implemented in routine urologic practice. This design allows assessment of the effectiveness of each intervention compared with usual care in a real-world procedural setting.
Masking
None (open label)
Enrolment
378 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07204301
Sponsor's protocol ID
16395
Acronym
Flexi-comfort
Status last verified
Sep 2025
First submitted
24 Sep 2025
Last updated
2 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Questions about this trial

What is this clinical trial studying?

A study testing Optimized Timing of Intravesical Lidocaine Gel, Calming Music During Procedure and Visual Distraction with Screen Content in people with Bladder Cancer, run by Western University, Canada at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Nicholas E Power, MD (519-667-6787, nicholas.power@lhsc.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient-reported Anxiety (VAS 0-100) (time frame: Before and immediately after the procedure (within 30 minutes).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2025.

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