About this trial
Cystoscopy is a procedure frequently performed in daily urological practice for the diagnosis of various urological conditions, including bladder tumors, benign prostatic hyperplasia, recurrent cystitis, and urethral strictures. Cystoscopy can be performed either in the operating room under sedation, spinal anesthesia, or general anesthesia, or in the outpatient setting under local anesthesia. Performing cystoscopy under outpatient conditions for patients requiring the procedure for follow-up and treatment indications is important in terms of reducing the workload of operating rooms. Although cystoscopy is generally well tolerated under local anesthesia in the outpatient setting, it may cause pain and anxiety in some patients, even when a flexible cystoscope is used. This may lead to adverse outcomes, particularly in patients with bladder tumors, due to loss to follow-up. Despite the use of analgesic methods such as lidocaine-based lubricants to reduce pain and anxiety before cystoscopy, an optimal solution has not yet been achieved. Moreover, some studies have reported that the level of pain experienced during cystoscopy increases with advancing age.
In male patients, several studies have demonstrated that the most painful moment during cystoscopy occurs when the tip of the cystoscope passes through the external urinary sphincter. It has been shown that asking patients to take deep breaths or allowing them to watch cystoscopy videos while manually compressing the irrigation fluid bag during the passage of the cystoscope through the bulbar urethra, just distal to the external urinary sphincter, can reduce pain perception. Female patients tend to experience less pain due to the shorter urethral length. Various strategies have been employed to minimize pain and anxiety during the procedure, including listening to music, watching relaxing videos, or allowing patients to view their own cystoscopy recordings during the examination. Given the lack of prior cystoscopy experience, we planned this randomized prospective study to evaluate the effect of age and sex on pain perception during flexible cystoscopy. We believe that the findings of this study may be beneficial in counseling patients during cystoscopic evaluation of urological pathologies
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Patients undergoing flexible cystoscopy for the first time under local anesthesia in an outpatient setting
Ability to understand the study procedures and provide informed consent
Disqualifiers
Use of systemic analgesics, sedatives, or anxiolytics immediately before the procedure
Presence of active urinary tract infection at the time of cystoscopy
Presence of an indwelling urethral catheter at the time of cystoscopy
Trial population
Adult patients (≥18 years) undergoing first-time flexible cystoscopy under local anesthesia in an outpatient setting, with assessment of expected and perceived pain levels
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Correlation between expected pain and perceived pain
Correlation between pre-procedural expected pain scores and post-procedural perceived pain scores with using a validated pain scale of Visual Analog Scale \[VAS\]
Secondary outcomes
Pre-procedural expected pain level
Expected pain level assessed immediately before the procedure using a validated pain scale (e.g., Visual Analog Scale \[VAS\], 0-10)
Difference between expected and perceived pain levels
Difference between pre-procedural expected pain score and post-procedural perceived pain score
Effect of age on pain perception
Association between patient age and post-procedural pain intensity during flexible cystoscopy
Effect of sex on pain perception
Comparison of post-procedural pain intensity between male and female patients undergoing first-time flexible cystoscopy
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