Comparing the effectiveness and lubricity of a novel Shea lubricant to 2% Lidocaine gel for digital rectal examination: a randomized non-inferiority trial

Abstract This study compared the level of lubricity and pain reduction of a novel shea lubricant to 2% lidocaine gel during digital rectal examination (DRE).Our research group performed a 9-week single blind non-inferiority trial at the Ho Teaching Hospital involving 153 patients. Primary outcome measure was the mean pain difference during the procedure using a Visual Analogue Scale. 75 and 78 patients were randomized to the shea lubricant and 2% lidocaine gel groups respectively. Analysis considered the per protocol population. The mean pain difference at end point was Δ -0.01. The 95% lower confidence interval was a -0.595 difference in means, above the non-inferiority (NI) limit of -0.720, thus establishing non-inferiority (Δ -0.01, 95% CI -0.59–0.57, NI -0.72). With secondary outcome measures, perianal pruritus (p = 0.728), discomfort (p = 0.446), bowel urgency (p = 0.077) and urinary urgency (p = 0.841) were similar except for bowel urgency which was worse for shea lubricant 30 minutes after DRE (p = 0.018). Shea lubricant had a better lubricity and ease of use (p = 0.002). While the novel shea lubricant achieved similar level of pain reduction as obtained with 2% lidocaine gel, it had better ease of performance and lubricity. This trial was registered with the Pan African Clinical Trials Registry on the 18/11/2020 with the unique identification number PACTR202011687956222.