Urinary tract infections in patients practicing intermittent catheterization

Poor bladder emptying is a well-known phenomenon in urology. Urine remaining in
the bladder increases the risk of an urinary tract infection (UTI).
Effective bladder emptying therefore is essential. This may be performed by
draining the bladder intermittently by means of a disposable catheter or by an
indwelling catheter. The method emptying the bladder intermittently is called
clean intermittent (self) catheterisation (CIC). Nowadays CIC is a commonly
recommended procedure for people with incomplete bladder emptying in order to
protect the bladder and renal health. It involves several times a day the
insertion of a disposable catheter into the bladder, outflow of the urine and
removal of the catheter. (Achterberg et al., 2006)


Urine normally does not contain microorganisms, but if urine is retained in the
bladder, it provides a good environment for bacteria to grow. Although CIC
insures bladder management to prevent complications as an UTI and
hydronefrosis, long-term catheterization can also cause an UTI (de Ridder,
2005). For example poor maintaining of following instructions or poor hygiene
can lead to bacteriuria and inflammation and subsequently pyelonefritis
(Getliffe, 2006).


Bacteria growing around the meatus can be introduced into the urethra to
manifest an UTI. Catheterisation can cause such introduction. The
microorganisms stick to the wall of the urethra, multiplying and moving up the
urethra to the bladder. Most UTI*s remain in the lower urinary tract, where
they cause symptoms such as urgency and burning sensation during micturition.
In general asymptomatic bacteriuria will not be treated. The blanket term UTI
is frequently used, but a urinary tract infection may also be identified by the
part of the urinary tract affected. Urethritis is an inflammation and/or
infection of the urethra. Bladder involvement is called cystitis, and when one
or two of the kidneys are inflamed or infected, it is called pyelonephritis.
In this study an UTI is defined as the combined outcome of bacteriuria (105
CFU/ML) and pyuria (> 10 white bloodcells/mm³) and one of the following
symptoms; frequency, urgency, dysuria, fever, stranguria or haematuria.


To a large extent the care for CIC patients is not evidence-based. Some studies
state that hydrophilic catheters might reduce UTI*s (Jaquet, 2009). According
to recent literature, approximately 30% of CIC patients get bacteriuria and
7-10% of the patients using CIC will get an UTI and need to be treated with
antibiotics (Rew. 2003). However, these numbers do not seem to reflect daily
practice and underreport the number of UTI*s. For example in Martini General
Hospital Groningen in the last two years, 32 % of the new CIC patients (n=123)
got an UTI within 6 months after starting CIC. This high incidence means that
more and more patients are treated with antibiotics by general
practitioners/urologists.
To detect an UTI urinalysis is needed. The most common way to analyse urine is
by means of a simple reagent strip. In this way abnormalities in the urine can
be detected.
A positive nitrite test on a reagent strip indicates bacterial infection.
Pyuria also indicates bacterial infection. If there are no symptoms,
antibiotics are normally not required. If systematic symptoms are present, full
microbiological analysis is warranted to prescribe specific and sensitive
antibiotics.

Suffering from an UTI influences patients quality of life. (Ellis. 2000). This
may lead to absence of work, loss of quality of life, taking more medicine
etc., resulting in more costs.

In summary, UTI*s are commonly seen in CIC patients. This can have great impact
on patients and healthcare expenders. However treatment and prevention of UTI*s
in CIC patients are largely not evidence-based.

Research questions:

* What is the incidence of UTI*s in patients in Martini General Hospital
Groningen and other Santeon hospitals using CIC to empty their bladder?
* What is the impact of an UTI on patients*quality of life and on illness
related (economic) costs e.g. direct costs of treatment, amount of hospital
visits, hospital recording, loss of productivity etc?

Study design and participants:
The study will be a prospective multi-centre observational trial. We will
perform the study within the Santeon network consisting of six large, top
clinical hospitals in the Netherlands (www.santeon.nl). These hospitals
collaborate on multiple domains, including scientific research. We aim to
include at least three other hospitals besides the Martini Hospital. In the
participating Santeon hospitals a nurse (specialist) will be trained in this
protocol and will locally coordinate the study. The overall coordination will
be done by the coordination team in the Martini hospital.

In the participating centres, patients starting CIC will be asked to
participate in the study. Patients starting CIC will receive standard care.
That is education according to the Dutch guideline (VenVN CVV; Verpleegkundigen
en Verzorgenden Nederland afdeling Continentie Verpleegkundigen en
Verzorgenden); association of Dutch nurses and carers department of
continence-care.
Standard catheter as given in the hospital or to patients* preference. Hence
different cathetertypes will be used

At baseline, and during the follow-up after one, three and twelve months an
urinary analysis will be done and patients are asked to fill in a questionnaire
on their health care consumption, quality of life, impact of an UTI and self
care behaviour. Moreover a selection of patients will be interviewed to get a
more in-depth view of their self-care and impact of the UTI (semi structured).
See flowchart of research fig 1.

If there are signs of an UTI during the study, patients are asked to come to
the hospital for urinary analysis and treatment if necessary.



Power and representativeness of the study population
The primary outcome measure is the occurrence of UTI*s. To assess the expected
30 % incidence of an UTI in this population with a 95% confidence interval of
plus or minus 5 % a sample of 384 patients is required.
These patients are retrieved from the populations of the Santeon hospitals
which account for more than 10% of the patients treated in Dutch general
hospitals. The Santeon hospitals can be considered to have a representative
sample of patients since they are almost non-restrictive in patient population,
i.e. provide both basic hospital care and complex care. Moreover, the Santeon
hospitals are geographically evenly distributed across the Netherlands in rural
and urban areas.

Minimal extent of burden and risk. The care given is acording to the standard.
During the follow-up a two time more visit is necessary.
During these visits patients will be asked to fill in a questionnaire. A
selection of patients will also be asked to have an interview.
Is symptoms of an UTI is present an extra visti to the hospital is necessary.



Minimale belasting. De gegeven zorg behoord tot de standaard zorg. Tijdens de
follow-up zal twee keer vaker dan normaal een controle volgen. Tijdens de
controle zal er een vragenlijst ingevuld dienen te worden. Bij een selecte
groep patiënten zal een interview worden afgenoemn.
Bij sympotmen van een UWI zal een tussentijds bezoek aan het ziekenhuis
noodzakelijk zijn.