A health-related quality-of-life study comparing Vitala continence control device versus traditional pouch system only in patients with end colostomy.

ABSTRACT

PURPOSE: The aim of this study was to evaluate the health-related quality-of-life (HRQL) impact of using the Vitala continence control device (CCD) in addition to the traditional pouch system among patients with an end colostomy. MATERIALS AND METHODS: End colostomy patients aged 18 years or older from the Czech Republic, Netherlands, and UK who were using at least 15 Vitala CCDs per month for at least 3 months and those using only pouches were surveyed over the Internet when possible or alternatively using a local personal computer arranged by a professional recruiter. The survey included the EQ-5D, Stoma Quality of Life Scale, Stoma Appliance-specific Questionnaire (SAQ), in addition to demographics and medical history. Univariate and regression analyses were performed to compare the HRQL between the patient groups. RESULTS: A total of 165 patients completed the survey 103 (62.4%) from the Czech Republic, 11 (6.7%) from the Netherlands, and 51 (30.9%) from the UK. Of these, 70 (42%) were Vitala CCD users. The mean age (±SD) was 62.5 (±10.9) years and 61.2% of the patients were men. Patients using the Vitala CCD on average had significantly higher scores on EQ-5D utility (0.84±0.20 vs. 0.75±0.25, P=0.013), EQ Visual Analog Scale (77.0±17.06 vs. 71.2±18.49, P=0.043), and SAQ (27.1±4.21 vs. 24.9±4.29, P=0.001). The Stoma Quality of Life Scale scores did not differ significantly between the groups. A higher proportion of Vitala CCD users had 'no problems' on all five EQ-5D domains (44.3 vs. 25.3%, P=0.010). A higher proportion of Vitala CCD users' scores were at or above the mean score of patients indicating 'enjoyed life' 'most of the time', for both the EQ-5D (64.3 vs. 48.4%, P=0.043) and the EQ Visual Analog Scale (67.1 vs. 51.6%, P=0.045). CONCLUSION: Findings from this study demonstrate that patients using the Vitala CCD appear to have better HRQL compared with those using only pouches. The difference might be meaningful to the patients, as reflected in the generic EQ-5D and the device-specific SAQ measures.