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.
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。