Randomized Double-Blind Controlled Trial Comparing Safety and Efficacy between Plain Lubricant and Lidocaine Gel during Ambulatory Cystoscopy

Abstract

Background: Cystoscopy is a basic procedure for urologists to visualize the urethra, the prostate gland, and the urinary bladder. However, ambulatory cystoscopy may be associated with pain and discomfort. Accordingly, varied types and amounts of lubricating gels were studied to relieve these symptoms. Objective: To compare the efficacy and safety between plain lubricant and lidocaine gel during ambulatory cystoscopy. Materials and Methods: The present study was a double-blind randomized controlled trial conducted to evaluate pain during cystoscopy. One hundred patients were randomized into two groups. Group A, 20 mL of 2% lidocaine hydrochloride gel and Group B, 20 mL of plain lubricant gel were instilled into urethra 15 minutes before the procedure. Pain was assessed by an independent data collector using a numerical rating scale (NRS) and visual analog score (VAS). Blood pressure and pulse rate were compared before and after the procedure. Complications were recorded by telephone within several days. Results: The mean NRS of Group A was lower (3.8±2.38) than that of Group B (4.22±2.65) (p=0.407) and the mean VAS of Group A was 2.7±1.36, Group B was 2.66±1.27 (p=0.880). Additionally, the present study found no difference in the change in mean arterial blood pressure (MAP) (Group A 6.69±11.18 mmHg, Group B 4.84±11.45 mmHg, p=0.416) and pulse rate (Group A 6.4±11.9 BPM, Group B 3.73±13.67 BPM, p=0.302). Gross hematuria was seen in one patient (2%) in Group A and three patients (6%) in Group B. Dysuria was equal in both groups. Conclusion: The plain lubricant gel used for cystoscopy without otherwise manipulation has similar safety and efficacy compared to the lidocaine gel. Keywords: Lubricant gel; Ambulatory cystoscopy; Cystoscopy without otherwise manipulation