Study design: Interventional, multi-center, open-label, randomized and crossover study.
Objectives: The study objectives were to describe the current catheterization habits of the French neurogenic bladder patients using intermittent catheterization (IC), and to evaluate the ease of use, reliability and patients' comfort and patients' acceptance of the new 'no-touch', presumably easy-to-use VaPro catheter.
Setting: Patients were recruited from 11 centers in France.
Methods: In total, 106 men and women (age 18-65 years) with neurogenic bladder using IC at least four times a day were randomized into two groups. All subjects were trained to use the approved 'no-touch' method. A questionnaire evaluating patients' experiences was distributed before the start of the trial and after each 15-day period of catheter use, that is, VaPro vs conventional catheter.
Results: The majority of patients in this French IC user panel had very strong catheterization habits: 2/3 of them had been using IC for >2 years with high ease of use and comfort. Nevertheless, >50% of patients would recommend the VaPro catheter to other people who need IC. More than three out of four patients felt confident and more secure with the new catheter. Men and spinal cord injury (SCI) patients were significantly more positive about the VaPro catheter than women and patients without SCI, respectively.
Conclusion: The VaPro catheter is an acceptable and reliable alternative to the existing hydrophilic-coated 'no-touch' catheter.
Sponsorship: This study was sponsored by Hollister France Inc.