Major Article
Impact of StatLock securing device on symptomatic catheter-related urinary tract infection: A prospective, randomized, multicenter clinical trial

https://doi.org/10.1016/j.ajic.2006.03.010Get rights and content

Background

The objective of this study was to assess the impact of using the StatLock securing device on symptomatic catheter-related urinary tract infection (UTI).

Methods

In this prospective, randomized, multicenter clinical trial, adult patients with spinal cord injury or dysfunction because of multiple sclerosis were randomized to have their indwelling bladder catheters secured in place by using the StatLock device (experimental group) versus preexisting methods (control group that included tape, Velcro strap, CathSecure, or none). Patients were monitored for the development of symptomatic UTI within the subsequent period of 8 weeks.

Results

Of a total of 127 enrolled patients, 118 (60 in the experimental group and 58 in the control group) were evaluable. The 2 groups of evaluable patients were comparable in terms of clinical characteristics and risk factors for infection. Symptomatic UTI was diagnosed in 8 of 60 (13.3%) patients in the experimental group versus 14 of 58 (24.1%) patients in the control group (P = .16; RR = 0.55, 95% confidence interval: 0.25-1.22).

Conclusion

Although the trial size precluded the demonstration of statistically significant differences, the finding of a 45% reduction in the rate of symptomatic UTI in patients who received the StatLock securing device is clinically relevant and prompts further investigations.

Section snippets

Study design

This prospective, randomized, multicenter clinical trial was approved by the institutional review boards of all 4 participating, tertiary care medical centers. Adult patients with SCI who were diagnosed with neurogenic bladder and required a long-term indwelling transurethral or suprapubic bladder catheter were eligible for enrollment in the study. After obtaining an informed consent from the patients or their legal guardians, enrolled patients were randomized (using a separate randomization

Patients and clinical characteristics

Of 127 enrolled patients, 9 were not followed for >10 days and, therefore, were excluded from analysis. The 9 excluded patients included 5 in the experimental group (2 voluntarily withdrew from the study and 3 developed UTI ≤10 days after enrollment) and 4 in the control group (1 withdrew from the study and 3 developed UTI ≤10 days after enrollment). A total of 118 patients (60 in the experimental group and 58 in the control group) were evaluable. The 2 groups of evaluable patients had

Discussion

Prevention of UTI, the most common health care-acquired infection, can be difficult to achieve, particularly in patients with long-term indwelling bladder catheters.15, 22 The results of this clinical trial indicate that the use of the StatLock securing device was associated with a 45% reduction in the rate of symptomatic UTI in patients with a catheter-dependent neurogenic bladder. Although this observed level of protection against UTI that was afforded by the use of the StatLock securing

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    Presented in part at the 15th Annual Meeting of the Society for Healthcare Epidemiology of America, Los Angeles, CA, 2005; Abstract No. 163.

    Supported by funds from the Department of Veterans Affairs, Washington, DC, and by a grant from Venetec International, San Diego, CA. The funding institutions played no role in the conduct of the study and did not contribute to the decision to submit the manuscript for publication.

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