Hypothesis / aims of study
Besides preventing upper urinary tract deterioration and symptomatic urinary tract infection, improving patient reported outcomes (PROs) in persons with spinal cord lesion (SCL) is attracting a lot of interest in the field of neurourology [1,2]. This study was a pre-planned exploratory fact-finding study using data derived from a burden of illness study, which was conducted with an internet survey of persons with SCL who were considered to be able to perform intermittent self-catheterization (ISC). We investigated PROs by types of urinary catheters in Japanese persons with SCL with a special attention to a reusable as well as an intermittent balloon catheter.
Study design, materials and methods
We performed a cross-sectional study by adult members of patient advocacy groups of traumatic as well as non-traumatic spinal cord injury and spina bifida, using an internet survey [3]. Despite a pre-planned study, the sample size was not calculated because this study was an exploratory one. PROs were evaluated by SF-Qualiveen, EuroQol 5-Dimension 5-Level (EQ-5D-5L), EQ Visual Analogue Scale (EQ VAS), and Work Productivity and Activity Impairment (WPAI). We compared these patient reported outcome measures (PROMs) between different types of catheters. The types of catheters in this study included an indwelling catheter (IDC), a reusable catheter (RC), a single-use catheter (SC), and an intermittent balloon catheter (i-IDC). The “REUSABLE” catheter is “NOT” a reuse of the SC but a specialized silicone catheter developed to be “REUSABLE”, which have been widely used for more than 30 years in Japan. At the time of this survey, most SCs were polyvinyl chloride catheters and a few hydrophilic catheters in Japan. The i-IDC is also a unique reusable one in order to prevent bladder overdistension and high-pressure urine storage in persons with nocturnal polyuria or difficulty with ISC when out, which should be left in place for a maximum of 12 hrs. Data were shown as mean (SD) when otherwise specified, and Mann-Whitney U test was used for statistical analysis. P <0.05 was considered to be statistically significant.
Results
A total of 282 persons were included in the analysis, of which 247 (87.6%) performed ISC and 35 (12.4%) were managed by IDC. Of persons in the ISC group, 136 (55.1%) and 111 (44.9%) used the RCs and SCs, respectively, and 45 (18.2%) used the i-IDC concomitantly. Findings of PROMs are shown in Table1, and items from SF-Qualiveen that revealed significant differences or tended to have differences are shown in Table 2.
Interpretation of results
Although we only performed descriptive statistical analyses in this study, we noticed complex associations between the type of catheter and PROs. Persons performing ISC would face particular difficulties when going out despite having higher QOL on EQ-5D-5L, compared with those managed with IDC. Taking findings of SF-Qualiveen domain scores, total score, and several individual scores into consideration, the Japanese “REUSABLE” silicone catheters have a potential to benefit selected persons with SCL, which should reduce economic concerns for stakeholders and environmental burden for the earth. Still not a satisfactory level, the results suggest that the i-IDC helps to maintain QOL in persons with SCL.