PURPOSE: Intermittent catheterization is the recommended standard treatment for neurogenic bladder dysfunction. However, standard intermittent catheters can be unwieldy, difficult to use and carry discreetly. This can influence patient ability to perform catheterization efficiently, discreetly and privately, therefore, affecting patient quality of life. We evaluated whether the discreet design of the compact catheter would improve quality of life in intermittent catheterization users compared with standard catheters. MATERIALS AND METHODS: We performed a nonblinded, randomized, multicenter, 2-way crossover study with 2 treatment periods of 6 weeks ± 3 days. A total of 125 patients with neurogenic bladder dysfunction were included in the study from 17 study sites, including 7 in France, 3 each in Germany, Denmark and Sweden, and 1 in Norway. Quality of life was evaluated by the intermittent self-catheterization questionnaire. The difference in questionnaire scores between the compact catheter and standard hydrophilic coated catheters was analyzed using a mixed linear normal model. RESULTS: The intermittent catheterization questionnaire score increased significantly due to compact catheter use. We noted an estimated mean difference of 17.0 between the compact and standard intermittent catheters (p <0.001), corresponding to a 28% increase. The primary study results were further supported by the positive results of the secondary objective of preference, that is 63% of patients preferred the compact catheter. CONCLUSIONS: The discreet design of the compact catheter significantly improved patient quality of life related to intermittent self-catheterization.
RCT Entities:
PURPOSE: Intermittent catheterization is the recommended standard treatment for neurogenic bladder dysfunction. However, standard intermittent catheters can be unwieldy, difficult to use and carry discreetly. This can influence patient ability to perform catheterization efficiently, discreetly and privately, therefore, affecting patient quality of life. We evaluated whether the discreet design of the compact catheter would improve quality of life in intermittent catheterization users compared with standard catheters. MATERIALS AND METHODS: We performed a nonblinded, randomized, multicenter, 2-way crossover study with 2 treatment periods of 6 weeks ± 3 days. A total of 125 patients with neurogenic bladder dysfunction were included in the study from 17 study sites, including 7 in France, 3 each in Germany, Denmark and Sweden, and 1 in Norway. Quality of life was evaluated by the intermittent self-catheterization questionnaire. The difference in questionnaire scores between the compact catheter and standard hydrophilic coated catheters was analyzed using a mixed linear normal model. RESULTS: The intermittent catheterization questionnaire score increased significantly due to compact catheter use. We noted an estimated mean difference of 17.0 between the compact and standard intermittent catheters (p <0.001), corresponding to a 28% increase. The primary study results were further supported by the positive results of the secondary objective of preference, that is 63% of patients preferred the compact catheter. CONCLUSIONS: The discreet design of the compact catheter significantly improved patient quality of life related to intermittent self-catheterization.
Authors: Lysanne Campeau; Samer Shamout; Richard J Baverstock; Kevin V Carlson; Dean S Elterman; Duane R Hickling; Stephen S Steele; Blayne Welk Journal: Can Urol Assoc J Date: 2020-07 Impact factor: 1.862
Authors: Andrei Krassioukov; Yasuhiko Igawa; Márcio Augusto Averbeck; Helmut Madersbacher; Andrew J Lloyd; Mette Bøgelund; Nikesh Thiruchelvam Journal: Med Devices (Auckl) Date: 2018-10-01