Comfort-Enhancing Techniques for Bladder Cancer

(Flexi-comfort Trial)

Overseen By Kaydee Connors

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Western University, Canada

Disqualifiers: Severe cognitive impairment, hypersensitivity, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether certain comfort techniques can make procedures for bladder cancer patients less painful and stressful. It aims to determine if calming music, ambient lighting, and other soothing methods can reduce anxiety and discomfort during cystoscopy (a procedure to look inside the bladder) and bladder treatments. Participants will receive either these comfort interventions or the usual care to assess which is more effective. People with bladder cancer who undergo regular bladder checks and experience anxiety or discomfort during the procedure might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance comfort for future patients during bladder procedures.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

What prior data suggests that these comfort-enhancing techniques are safe for bladder cancer patients?

Research shows that the treatments tested to ease pain and anxiety during bladder procedures are generally safe. Let's break it down:

For the timing of lidocaine gel, studies suggest that while it might not significantly reduce urinary symptoms, using lidocaine is common and usually safe for bladder procedures.

Listening to calming music during similar procedures has reduced pain and anxiety. It's a simple and safe way to improve the patient experience.

Watching a screen for visual distraction has also been used safely. Studies found that it can lower pain and anxiety without any side effects.

The peak-end modification, which involves holding the cystoscope in place briefly at the end, has reduced remembered pain and anxiety without causing harm.

Using calming ambient lighting, like blue light, has been reported as safe and well-tolerated in similar medical settings.

Overall, these comfort-enhancing methods are not only safe but also potentially helpful in making the procedure more comfortable. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these new comfort-enhancing techniques for bladder cancer procedures because they aim to make the experience less stressful and more bearable for patients. Unlike traditional methods that focus mainly on the medical aspect, these techniques incorporate calming ambient lighting, soothing music, and visual distractions to create a more relaxed environment during procedures. Additionally, the optimized timing of intravesical lidocaine gel and the innovative use of the peak-end rule seek to minimize discomfort and improve the overall remembered experience. These approaches are unique because they address the psychological and sensory aspects of the procedure, potentially transforming how patients perceive and tolerate bladder cancer treatments.

What evidence suggests that these comfort-enhancing techniques are effective for reducing pain and anxiety during bladder cancer procedures?

Research shows that the comfort-enhancing techniques studied in this trial can reduce pain and anxiety during bladder procedures. Participants may receive different interventions, such as the optimized timing of lidocaine gel, which several studies have proven to significantly lower pain during cystoscopy. Another group may listen to calming music during the procedure, which can also reduce pain and anxiety, as supported by findings from three out of four studies. Watching relaxing videos is another option being tested, which can help lessen pain and improve patient satisfaction. The peak-end modification technique, which involves ending the procedure on a calm note, is also being evaluated for its potential to meaningfully decrease pain and anxiety. These methods aim to make the procedure more comfortable by focusing on both physical and mental comfort. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for bladder cancer patients undergoing flexible cystoscopy and bladder instillation. Participants must be able to complete questionnaires about their pain, comfort, and anxiety levels during the procedure.

Inclusion Criteria

Able to provide informed consent

I am 18 years old or older.

I have bladder cancer and am getting cystoscopy or treatment in the clinic.

Exclusion Criteria

Individuals unable to communicate verbally with study staff (e.g., severe speech/hearing impairment without assistive support available)

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo flexible cystoscopy or bladder instillation with or without comfort interventions

1 day

1 visit (in-person)

Follow-up

Participants complete questionnaires assessing comfort, pain, and anxiety immediately post-procedure and within 24 hours

1 day

1 visit (virtual or phone)

Observational

Observational data collected from a cohort undergoing standard care for comparison

Concurrent with treatment phase

What Are the Treatments Tested in This Trial?

Interventions

• Calming Ambient Lighting
• Calming Music During Procedure
• Optimized Timing of Intravesical Lidocaine Gel
• Peak-End Modification of Procedure
• Visual Distraction with Screen Content

Trial Overview The study tests if interventions like optimized timing of anesthetic gel, calming ambient lighting, visual distractions, and calming music can reduce pain and anxiety compared to standard care during cystoscopy and bladder instillation.

How Is the Trial Designed?

Group I: Visual Distraction Experimental Treatment 1 Intervention

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

Group II: Peak-End Modification Experimental Treatment 1 Intervention

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.

Group III: Optimized Anesthetic Gel Timing Experimental Treatment 1 Intervention

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

Group IV: Calming Music Experimental Treatment 1 Intervention

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

Group V: Ambient Lighting Experimental Treatment 1 Intervention

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

Group VI: No Intervention Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Western University, Canada

Lead Sponsor

Trials

270

Recruited

62,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07204301

Study Details | NCT07204301 | Enhancing Patient Comfort ... The goal of this clinical trial is to learn if certain comfort-enhancing interventions can reduce pain and anxiety during flexible ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/27780784/

Comparative Effectiveness of Fluorescent Versus White ... Abstract. Purpose: We systematically reviewed the comparative effectiveness of fluorescent vs white light cystoscopy on bladder cancer clinical outcomes.

3. urotoday.com urotoday.com/video-lectures/bladder-cancer/video/4006-va-bravo-2-study-blue-light-cystoscopy-improves-outcomes-in-nmibc-patients-in-equal-access-setting-stephen-b-williams.html

VA BRAVO 2 Study: Blue Light Cystoscopy Improves ... We notice a significantly decreased risk of recurrence, decreased progression and improved overall survival in patients who underwent blue light cystoscopy.

4. cysviewhcp.com cysviewhcp.com/evidence-and-patient-cases/

Clinical evidence supporting use of Blue Light Cystoscopy ... A prospective, open-label, within-patient controlled, clinical trial using BLC with Cysview in the detection of bladder cancer during surveillance cystoscopy.

5. urotoday.com urotoday.com/conference-highlights/aua-2023/aua-2023-bladder-cancer/143973-aua-2023-mp08-15-the-role-of-flexible-blue-light-cystoscopy-in-surveillance-of-non-muscle-invasive-bladder-cancer-results-from-a-nordic-registry.html

AUA 2023: The Role of Flexible Blue Light Cystoscopy in ... Available, recorded data included patients' demographics, patients' bladder cancer history, findings on blue light and white light ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24768013/

Safety of hexaminolevulinate for blue light cystoscopy in ... Safety of hexaminolevulinate for blue light cystoscopy in bladder cancer. A combined analysis of the trials used for registration and postmarketing data.

7. cinj.org cinj.org/patient-care/blue-light-cystoscopy

Blue Light Cystoscopy Clinical studies have shown that blue light cystoscopy is safe and well tolerated. Patients should discuss with their provider if the procedure is right for ...

8. researchgate.net researchgate.net/publication/363068174_The_use_of_blue-light_cystoscopy_in_the_detection_and_surveillance_of_nonmuscle_invasive_bladder_cancer

(PDF) The use of blue-light cystoscopy in the detection and ... Conclusions: Office-based blue light flexible cystoscopy significantly improves detection of patients with recurrent bladder cancer, and is safe ...

9. pennmedicine.org pennmedicine.org/treatments/blue-light-cystoscopy

Blue Light Cystoscopy (Bladder Scope) Research has shown that blue light cystoscopy is generally safe. Our bladder cancer surgeons can help you decide if it's right for you.