urinary tract infections in CIC patients and impact of UTI
Conditions
Interventions
None listed
Sponsors
Martini Ziekenhuis
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: Patients needing CIC to empty their bladder properly (residu after voiding/ retention) or needing CIC to prevent strictures of the urethra
Exclusion criteria
Exclusion criteria: patients younger than 18 years, patients who are pregnant or get pregnant during the study, mentally-retarded or demented patients, patients starting with antibiotics precautionary longer then three days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome is the incidence of UTI*s in CIC patients. In the field of Urology, there is no universal consensus for the definition of UTIs However, classification of UTIs is important for clinical decisions and research. In this study we based the definition for UTIs on the classifications of the Centres of Disease and Prevention in de USA (CDC 2008), the classification of the European Assosiation of Urology (EAU 2010) and Prezies 2012 (Dutch guidelines of hospital infections); this guideline Is also based on the CDC classifications. In fact, these definitions are rather similar and reflect the opinion of the major expert groups in this field. The current classifications of UTIs are based on the concept of two main categories: uncomplicated and complicated UTIs. An uncomplicated UTI/asymptomatic bacteriuria (ASB) is considered not as an infection but a risk factor for a UTI. A Symptomatic UTI is present if there are clinical symptoms indicative of UTI and if the presence of pathogens can be verified by culture or dipstick. The clinical presentation is classified as cystitis (dysuria, frequency, urgency, suprapubic pain), pyelonefritis (fever, flank pain). Significant bacteriuria in adults is considered * 105 uropathogens/ml in midstream urine of women or 104 uropathogens/ml of midstream urine in men with complicated UTI (EAU2012) UTI in concrete defined in this study: the combined outcome of bacteriuria (105 CFU/ML) and pyuria (> 10 white bloodcells/mm³) and one or more of the following symptoms; frequency, urgency, dysuria, stranguria, fever or haematuria. Urinary analysis will be based on a reagent test and if positive (for nitrite) as well on full-microbiological analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| The Secondary outcomes are: * The impact of UTI in daily life measured by questionnaire and interviews * Self-care behaviour, measured by interviews * Health related quality of life measured by the Rand-36 (Van der Zee 1993) * Health-care consumption based on hospital records/patient files and a checklist for patients Confounders are patient characteristics (e.g. gender, age, educational level), catheter type, frequence of CIC and clinical features (e.g. disease status). All measurements (except demographics) will be done at baseline, one month, three, and twelve months follow. | — |
Countries
Netherlands
Outcome results
None listed