Hypothesis
pruritus, pain
Our hypothesis is to test whether the shea lubricant can achieve the same level of pain reduction as obtained with the use of 2% lidocaine gel for digital rectal examination, at a better ease of performing the procedure. The confirmation of non-inferiority involved the pre-specification of a mean pain difference for shea lubricant as compared to 2% lidocaine gel below a predefined margin, based on a relative measure.Primary outcome measures—mean difference in pain perception during the procedure with a non-inferiority limit set at − 0.72.Secondary outcome measures—differences in the perception of discomfort, peri-anal pruritus, bowel and urinary urgency during the procedure using Likert scales. Secondly, to assess the ease of use of the lubricants by trial doctors.