The Impact of Age and Sex on Anticipated and Experienced Pain in First-Time Outpatient Flexible Cystoscopy

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKayseri Education and Research Hospital

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

150 Participants
are grouped into 1 trial group
Group A: First-Time Flexible Cystoscopy Under Local Anesthesia Patient Group

Trial outcomes

Primary outcomes

1

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 \[VAS\]

Time frame
Immediately after completion of the cystoscopy procedure

Secondary outcomes

1

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)

Time frame
Immediately before flexible cystoscopy
2

Difference between expected and perceived pain levels

Difference between pre-procedural expected pain score and post-procedural perceived pain score

Time frame
From immediately before to immediately after the procedure
3

Effect of age on pain perception

Association between patient age and post-procedural pain intensity during flexible cystoscopy

Time frame
Immediately after the procedure
4

Effect of sex on pain perception

Comparison of post-procedural pain intensity between male and female patients undergoing first-time flexible cystoscopy

Time frame
Immediately after the procedure

Other outcomes

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