Trial process
tenderness, tightness, streaks of blood or any discharge, prostate
STERILE, PROSTATE
In all, two trial nurses independent of the study and eight (8) trial doctors were recruited. To ensure quality control, reliability and reproducibility, the trial recruits were trained in data collection, trial protocols and procedures, seeking informed consent and safe disposal of waste. The investigational products were stored at the hospital’s pharmacy under ambient conditions. The lubricants were prepared by the independent trial nurses and delivered in marked 5 ml—syringes labelled A and B to trial doctors. The control lubricant (Optilube active gel) has similar constituents to the reference lubricant used in previous trialsAll DRE examinations were done in the presence of a chaperone due to the sensitivity of the procedure. After explaining the procedure and seeking consent, participants were asked to undress including undergarments in privacy. A gown was used to preserve modesty till the procedure was performed. Patients were made to lie on a couch in the left lateral position facing away from the examiner with the legs drawn up towards the chest. The examiner puts on sterile gloves and the examination starts with the inspection of the natal clefts (the groove between the buttocks), the anus and the perianal skin for lesions. Any lesion that constitutes a contraindication (refer to inclusion/exclusion criteria) led to the abandonment of the procedure. The patient is then asked to bear down, observing for lesions. The examiner lubricates the examining finger with 5 mls of the selected lubricant. At this stage, the examiner alerts the patient about the commencement of the procedure. The examiner gently pats the buttocks and applies gentle pressure at the anal margin to enter the anus and the rectum. The anal tone is determined by asking the patients to “squeeze” on the examining finger and release it. The finger is then directed posteriorly following the curve of the sacrum observing for any lesions, tenderness, tightness and mobility of the rectal mucosa. The finger is then swept anteriorly in a clockwise direction to examine the prostate in men and the pouch of douglas in women. The examination is completed by inspecting the examining finger for the nature of fecal matter, streaks of blood or any discharge.