RESUMO
STUDY DESIGN: Prospective, unblinded, multicenter, randomized, controlled, cross-over study assessing user preference and ease of use characteristics of two gel intermittent catheters in 81 self-catheterizing wheelchair-using men. OBJECTIVES: To evaluate the male user's preference between a 30-cm and a 40-cm intermittent catheter (Apogee Intermittent Catheter, Hollister Incorporated, Libertyville, IL, USA) regarding the ease of insertion and removal, ability to control the catheter during insertion, bladder emptying confidence and ease of draining urine into a receptacle or connecting to a urine bag. SETTING: Multiple institutions in the United States. METHODS: Subjects were randomized to order of catheter use, using both 10 test catheters (30-cm) and 10 control catheters (40 cm). All catheters were 12 or 14 French and identical in design and composition, except length. Safety was assessed during the entire study period regarding adverse events (AE) and adverse device events (ADE). Subjects evaluated their ease of use characteristics after each catheter use and final catheter preference. RESULTS: Subjects preferred the Apogee 40-cm intermittent catheter (91.4%) over the 30-cm length (8.6%). The preference was due to subject confidence of complete bladder emptying (70%), more satisfactory length (74%) and easier to drain into a receptacle (58%) with a portable urinal being the most utilized (37%), followed by toilet (35%). The only AE/ADE reported was minor urethral bleeding in one subject and minor pain in another subject, both with the 30-cm catheter. None were reported with the 40-cm catheter. CONCLUSIONS: The Apogee 40-cm catheter was the preferred intermittent catheter due to subject confidence in bladder emptying, ease of catheter manipulation and the ease of draining urine into a receptacle.