Comparative analysis of immediate and delayed insertion of flexible cystoscope after application of topical anaesthetic lubricant on patient comfort

INTRODUCTION

The earliest use of fiberscope cystoscopy was by Marshall in 1964.¹ The earliest reported use of flexible cystoscope was by Tsuchida and Sugawara.² The regular use of the flexible cystoscope started in the first few years of the 1980s.^3,4 It has since evolved and is currently the most commonly performed urological procedure.⁵

The procedure is usually performed by the most junior members of the team as the level of skills required for this procedure are basic and attained pretty quickly. However it can be uncomfortable and painful even in experienced hands. There are two controversial aspects involved, the first one whether a simple lubricant or topical anaesthetic should be used and second one whether to perform cystoscopy immediately or delayed after application of topical anaesthetic. This study focussed on the second aspect and a prospective study was carried out comparing pain scores after lignocaine gel application in 127 male patients who underwent immediate or delayed flexible cystoscopy depending on the group they belonged.

METHODS

This prospective comparative trial was registered as an audit with Medway Maritime Hospital (ethical committee) but as the results were encouraging it was extended as a research project. Men undergoing flexible cystoscopy were randomized to undergo flexible cystoscope insertion either immediately after topical lubrication with lignocaine gel or after a 3-minute delay by the watch. Pain during the procedure was recorded on a visual analogue scale (scale from 1-10) and the data were analysed at the end of the study. All the successive patients with valid indications for flexible cystoscopy were recruited over a period of three months. The patients were informed about the trial and recruited only after their approval for randomisation. The indications for the office based flexible cystoscopy were visible/ nonvisible haematuria (microscopic and macroscopic haematuria), haematospermia, storage lower urinary tract symptoms, recurrent urinary tract infections and non-muscle invasive bladder cancer surveillance (Table 1). The patients were randomly assigned to the two groups without patient’s knowledge to which group they belonged to. Exclusion criteria included extremes of age (less than 20 years or more than 90 years), female patients, urethral stricture or where the passage of the cystoscope into the bladder was not possible and cystoscopy from suprapubic tract. The procedure was performed by two experienced senior urology middle grade registrars. In the supine position, skin prepped with chlorhexidine and 10 ml of lignocaine 2% gel with chlorhexidine was instilled into the urethra. Patients randomized to 3-minute delay cohort had their urethra clamped at the glans between two fingers. In the immediate cystoscopy cohort 10 ml of topical anaesthetic was instilled in the urethra followed by insertion of the cystoscope without any delay. Following completion of the procedure, the patients would mark discomfort/pain on a scale from 1-10, in absence of the urologist in the room. In the patients who couldn’t speak English an interpreter would assist in the marking on the visual analogue score. The statistics were performed by the unpaired “t” test.

RESULTS

A total of 127 men were randomized in the two groups, immediate group (n=84) and the delayed group (n=43). Mean pain score in the immediate group (n=84) was 1.69 whereas mean pain score in the delayed group (n=43) was 1.70 (p=0.9854) (Figure 1).

Overall 45 patients had cystoscopy for the first time, the mean pain score in the immediate group (n=28) was 2.54 whereas mean pain score in the delayed group (n=17) was 1.41 (p=0.1095) (Figure 2).

22 patients were younger than 50 years of age. Of these 13 patients were in the immediate group and they had mean pain score of 3.08. In the delayed group, there were 9 patients whose mean pain score was 1.33 (p=0.1455).

In the younger age immediate group, mean pain score in the subset of patients who underwent cystoscopy for the first time was (n=7) was 4.71, whereas it was 0.33 in delayed cystoscopy sub-group (n =6). The p value equals 0.0037. However the sample size was small.

105 patients were older than 50 years of age. In this cohort, 71 patients were in the immediate group with mean pain score of 1.44. 34 patients were in the delayed group and had mean pain score - 1.79 (p=0.3724).

In above 50 years immediate group, mean pain score in the sub-group of patients who underwent cystoscopy for the first time (n=22) was 1.81, whereas it was 2.0 in the delayed sub-group (p=0.7904) (Table 2).

From our study, we found that Flexible cystoscopy is a well-tolerated procedure, however in patients who are younger than 50 years of age delaying cystoscope insertion by 3 minutes after lubrication with topical lignocaine gel reduces pain, especially if the patients are having flexible cystoscopy for the first time. In men older than 50 years of age, delaying cystoscope insertion by 3 minutes after insertion of local anaesthetic gel makes no difference in pain scores, analgesia and patient comfort.

DISCUSSION

Flexible cystoscopy is a common urological procedure. The procedure is uncomfortable in both sexes however it is more so in males due to presence of the prostate gland and long urethral sphincter.⁶ 2% lidocaine gel is commonly used as a topical anaesthetic for the procedure but some clinicians’ only use lubricant without local anaesthetic. Further some investigators have suggested alternative analgesia including intravenous sedation, inhalation analgesia and even the role of per-rectal diclofenac suppositories.^7-9 However, there is controversy whether local anaesthetic gel facilitates flexible cystoscope insertion by mechanism of analgesia or lubrication only.⁷ Several studies have successfully demonstrated that in men topical anaesthetic functions mainly by mechanism of analgesia rather than lubrication only.^11-13 However this was not confirmed in the meta-analysis by Patel et al.^14,15

The other conflicting point is about the waiting or the retention time of the topical anaesthetic gel in the male urethra prior to the insertion of scope. In our study, we found that immediate flexible cystoscopy after lubrication with topical local anaesthetic provides similar patient comfort compared with delayed insertion by 3-minute interval. There was no difference in the outcome whether patients are having first or repeat flexible cystoscopy. This is supported by evidence from previous studies which have shown that shorter, clinically manageable time delay between lubrication and insertion of the cystoscope is equally effective compared to delayed insertion of the scope.¹⁶ On the other hand there is evidence that a retention time of 15-25 minutes significantly reduces pain from the procedure.¹⁷

Only young men who are having flexible cystoscopy for the first time have better analgesia and lower pain scores with delayed scope insertion. There is an option of considering additional/alternative analgesia or performing the procedure under general anaesthesia in the young men. Our study shows that the overall pain scores are very low indicating flexible cystoscopy is a very well tolerated procedure in experienced hands and patient friendly environment.

CONCLUSION

Flexible cystoscopy is a well-tolerated procedure, however in patients who are younger than 50 years of age delaying cystoscope insertion by 3 minutes after lubrication with topical lignocaine gel reduces pain, especially if the patients are having flexible cystoscopy for the first time. In men older than 50 years of age, delaying cystoscope insertion by 3 minutes after insertion of local anaesthetic gel makes no difference in pain scores, analgesia and patient comfort.

ACKNOWLEDGEMENTS

ZRB compiled the data and wrote paper, ZB and MMW helped in editing and processing of the paper.

Funding: No funding sources

Conflict of interest: None declared

Ethical approval: The study was approved by the Institutional Ethics Committee

REFERENCES

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