Abstract：
OBJECTIVE: It has been proposed that reusable catheters are more cost effective and environmentally sustainable than single-use catheters intended for intermittent catheterization (IC). However, the aspect of individuals\' well-being and preference for catheter type is not considered. In this study, we investigated the impact on individuals\' health-related quality of life (HR-QoL) when testing a reusable catheter.
METHODS: The study was an open-labeled, single-arm, multicenter investigation with a treatment period of 28 days. Forty subjects using single-use hydrophilic catheters were accustomed to a reusable catheter for managing IC. HR-QoL was evaluated by the Intermittent-Self Catheterization Questionnaire (ISC-Q). Additionally, satisfaction was evaluated by the Intermittent Catheterization Satisfaction Questionnaire (InCaSa-Q). The difference in total score was analyzed using a mixed linear model. Furthermore, preference for IC (single-use vs. reusable) was assessed and microbial evaluation of the catheters was performed.
RESULTS: The total ISC-Q score measuring HR-QoL decreased significantly by 28% (p < 0.001). Two of the four subdomains (ease-of-use and discreetness) also decreased significantly (p < 0.001). The total InCaSa-score and all four subdomains evaluating satisfaction decreased significantly (p < 0.005). The primary study results were supported by the fact that 90.9% of subjects preferred to use a single-use catheter for IC. Furthermore, 50% of reusable catheters were contaminated with bacteria.
CONCLUSIONS: Switching from single-use to reusable IC resulted in a significant decrease in HR-QoL and satisfaction. Moreover, the vast majority preferred the single-use catheter due to handling and convenience. The users\' rights to their preferred bladder management method should be acknowledged.
METHODS: The study was an open-labeled, single-arm, multicenter investigation with a treatment period of 28 days. Forty subjects using single-use hydrophilic catheters were accustomed to a reusable catheter for managing IC. HR-QoL was evaluated by the Intermittent-Self Catheterization Questionnaire (ISC-Q). Additionally, satisfaction was evaluated by the Intermittent Catheterization Satisfaction Questionnaire (InCaSa-Q). The difference in total score was analyzed using a mixed linear model. Furthermore, preference for IC (single-use vs. reusable) was assessed and microbial evaluation of the catheters was performed.
RESULTS: The total ISC-Q score measuring HR-QoL decreased significantly by 28% (p < 0.001). Two of the four subdomains (ease-of-use and discreetness) also decreased significantly (p < 0.001). The total InCaSa-score and all four subdomains evaluating satisfaction decreased significantly (p < 0.005). The primary study results were supported by the fact that 90.9% of subjects preferred to use a single-use catheter for IC. Furthermore, 50% of reusable catheters were contaminated with bacteria.
CONCLUSIONS: Switching from single-use to reusable IC resulted in a significant decrease in HR-QoL and satisfaction. Moreover, the vast majority preferred the single-use catheter due to handling and convenience. The users\' rights to their preferred bladder management method should be acknowledged.
摘要：
目的：有人提出，可重复使用的导管比旨在用于间歇性导管插入术（IC）的一次性导管更具成本效益和环境可持续性。然而,不考虑个人的健康和对导管类型的偏好。在这项研究中,我们调查了在测试可重复使用的导管时对个体健康相关生活质量(HR-QoL)的影响.
方法：这项研究是一项开放标签，单臂,多中心调查，治疗期为28天。使用一次性亲水导管的40名受试者习惯于可重复使用的导管来管理IC。HR-QoL通过间歇性自我导尿问卷（ISC-Q）进行评估。此外,满意度通过间歇性导管插入满意度问卷（InCaSa-Q）进行评估。使用混合线性模型分析总分的差异。此外，首选IC(一次性使用与可重复使用）进行了评估，并对导管进行了微生物评估。
结果：测量HR-QoL的ISC-Q总评分显著下降28%(p<0.001)。四个子域中的两个（易用性和离散度）也显着降低（p<0.001）。总InCaSa评分和所有四个评估满意度的子域均显着降低（p<0.005）。主要研究结果得到了以下事实的支持：90.9％的受试者更喜欢使用一次性导管进行IC。此外，50%的可重复使用的导管被细菌污染。
结论：从一次性使用IC切换到可重复使用IC导致HR-QoL和满意度显着下降。此外，由于操作和便利性，绝大多数人首选一次性导管。应确认用户对其首选膀胱管理方法的权利。
方法：这项研究是一项开放标签，单臂,多中心调查，治疗期为28天。使用一次性亲水导管的40名受试者习惯于可重复使用的导管来管理IC。HR-QoL通过间歇性自我导尿问卷（ISC-Q）进行评估。此外,满意度通过间歇性导管插入满意度问卷（InCaSa-Q）进行评估。使用混合线性模型分析总分的差异。此外，首选IC(一次性使用与可重复使用）进行了评估，并对导管进行了微生物评估。
结果：测量HR-QoL的ISC-Q总评分显著下降28%(p<0.001)。四个子域中的两个（易用性和离散度）也显着降低（p<0.001）。总InCaSa评分和所有四个评估满意度的子域均显着降低（p<0.005）。主要研究结果得到了以下事实的支持：90.9％的受试者更喜欢使用一次性导管进行IC。此外，50%的可重复使用的导管被细菌污染。
结论：从一次性使用IC切换到可重复使用IC导致HR-QoL和满意度显着下降。此外，由于操作和便利性，绝大多数人首选一次性导管。应确认用户对其首选膀胱管理方法的权利。
