Evaluation of a New Intermittent Urinary Catheter for Adult Men Using Hydrophilic Catheters Assessing Safety, Usability, and Performance Compared to Current Catheters

What this Trial Is About

This research aims to evaluate the initial safety and performance of a new intermittent urinary catheter designed for adult men who use hydrophilic intermittent catheters. The study focuses on male participants who self-catheterize multiple times daily and compares the investigational catheter to their current catheter products. The purpose is to gather detailed information on safety, usability, comfort, satisfaction, and overall catheter performance. Participants will first use 30 of their usual hydrophilic intermittent catheters and then switch to using 30 of the investigational study catheters in a fixed sequence. During both periods, they will complete daily questionnaires about catheter use, comfort, ease of insertion, bladder drainage, confidence, and satisfaction. The study also monitors health changes and any adverse events experienced. Throughout the study, participants provide feedback on various aspects of catheter use including insertion ease, bladder emptying, catheter handling, discomfort, and overall preference. Researchers will assess safety by tracking health changes and adverse events. The total study duration for each catheter-use period is approximately 6 to 20 days, during which participant experience and device performance are carefully monitored.

Consumer Evaluation of an Investigational Intermittent Catheter