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2 0 0 5 B J U I N T E R N A T I O N A L | 9 6 , 5 6 6 5 71 | doi:10.1111/j.1464-410X.2005.05685.x
Original Article
ECONOMICS OF ALFUZOSIN FOR MANAGING AUR IN THE FIRST 6 MONTHS
ANNEMANS
et al.

The economic impact of using alfuzosin 10 mg once daily
in the management of acute urinary retention in the UK:
a 6-month analysis

LIEVEN ANNEMANS*, IRINA CLEEMPUT, MARK LAMOTTE, ALAN McNEILL and TIMOTHY HARGREAVE

*Department of Public Health, Ghent University, Ghent, Federal Knowledge Centre, Brussels, HEDM, Brussels, Belgium, Department of Urology,
Western General Hospital, and Department of Oncology, University of Edinburgh, Scotland, UK

Accepted for publication 19 April 2005

options within the rst 6 months after a rst
episode of AUR. Clinical data were obtained
from a large randomized clinical trial
comparing alfuzosin 10 mg with placebo, and
from published reports. Cost data were
obtained from both NHS and resource-use
data gathered during the clinical trial. A
Monte Carlo analysis, allowing variability in all
uncertain variables of the model, was used to
calculate the uncertainty surrounding the
results.

RESULTS

Treating patients with alfuzosin during initial
hospitalization for AUR and in the rst
6 months after a successful TWOC generates a
cost-saving of 349 relative to placebo.
Savings related to immediate prostatectomy
were 892; both savings were signicant
(

P



<

0.05). Alfuzosin treatment was
associated with a lower rate of prostatectomy
after discharge from hospital after a
successful TWOC.

CONCLUSION

Treatment with alfuzosin 10 mg once daily
before and after a successful TWOC has both
clinical and economic benets. It decreases
the need for emergency surgery for BPH and
reduces treatment costs in the rst 6 months.

KEYWORDS

acute urinary retention, cost, trial without
catheter, alfuzosin, prostatectomy,

a

-blocker

OBJECTIVE

To calculate the economic consequences of
using alfuzosin 10 mg once daily for
managing acute urinary retention (AUR)
related to benign prostatic hyperplasia (BPH).

METHODS

We examined whether alfuzosin use during
hospitalization for AUR and for 6 months
after a successful trial without catheter
(TWOC) is cost effective compared to placebo
and immediate prostatectomy, from the
perspective of patients managed in the
National Health Service (NHS) in the UK. A
decision-analysis model was developed to
estimate the costs of various treatment

INTRODUCTION

Acute urinary retention (AUR) is a common
complication of ageing men with BPH. Risk
factors for AUR include old age, increased
prostate volume, postvoid residual volume,
severe LUTS and reduced peak urinary ow
rate [1,2]. Reported incidence rates of AUR
vary widely, at 0.425% per year in men seen
in urological practice [2]. From a large cohort
of 2115 community-dwelling men aged
4079 years in Minnesota (USA), it was
estimated that a 60-year-old man had a 23%
probability of experiencing an episode of AUR
if he survived another 20 years [3].
The immediate treatment of AUR is
catheterization, which may be followed by
semi-urgent (immediate) BPH surgery or a
trial without catheter (TWOC). A success rate
of 2357% was reported in patients who had
a TWOC with no concomitant medical therapy
in observational studies [4,5] or in the placebo
arms of small randomized studies [6,7]. The
duration of catheterization strongly
inuences the success rate of a TWOC [8] and
probably contributes to the large variability of
TWOC results. Men in whom the TWOC fails
are usually offered surgery for BPH.

a

1

-blockers have been shown to increase the
success rate of TWOC in patients presenting
with AUR [6,7]; by reducing sympathetic tone,
they reduce bladder outlet resistance and
postvoid residual urine, two factors important
in the development of AUR [2]. There is a
greater morbidity and mortality associated
with emergency surgery after AUR [2,9], and
therefore any treatment that increases the
success rate of a TWOC should be of benet.
Alfuzosin is a uroselective

a

1

-blocker that
may be used in the medical management of
AUR. The largest clinical trial published to
date (ALFAUR Study [10]) recruited 357
patients presenting with a rst episode of
AUR, and showed the short- and medium-
term (6 months) clinical effectiveness of
alfuzosin. Of the patients treated with
alfuzosin, 61.9% had a successful TWOC,
compared with 47.9% on placebo (

P



=

0.012).
In the follow-up, 165 patients with a
successful TWOC were re-randomized to
receive alfuzosin or placebo for 6 months; 20
(24%) of 83 placebo-treated patients needed
BPH surgery in the rst 6 months after
discharge from hospital, compared to 14/82
(17%) with alfuzosin. This 30% reduction in
the risk of BPH surgery with alfuzosin was not
signicant (

P



=

0.202), probably because
there were too few patients, but it is still
clinically signicant, i.e. 14 men would need
to be treated with alfuzosin for 6 months to
prevent one BPH surgery event.
In addition to the observed clinical benet,
the use of

a

1

-blockers in men with AUR may
have economic consequences. Although a
higher success rate of TWOC may decrease
costs associated with surgery and in-hospital
treatment, this has to be balanced against the
cost of medication. The economic impact of
using alfuzosin in the treatment of men with
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AUR has not previously been accounted.
Improved healthcare for the majority will only
be affordable in the context of cost-effective
treatments, and thus all new interventions
should be subject to economic as well as
clinical analysis.
Thus the objective of the present study was to
examine the impact of alfuzosin 10 mg once
daily on the treatment costs of AUR, when
this medication is used during the initial
hospitalization and the rst 6 months after
discharge from hospital and after a successful
TWOC, by comparing the treatment costs of
placebo with semi-urgent (immediate)
inpatient prostatectomy.

METHODS

The study used a simple decision-modelling
design that reects the design of the ALFAUR
study. A graphical presentation of the
decision model is given in Fig. 1. During
the initial hospitalization phase (index
hospitalization) there are mainly three
treatment options, which are the three
comparators in the present model: (i) TWOC
with previous intake of alfuzosin 10 mg once
daily (alfuzosin); (ii) TWOC with no

a

-
blockade (approximated by the placebo results
of phase 1 of the ALFAUR study, see below);
and (iii) immediate prostatectomy. The last
option was not an arm in the ALFAUR trial but
was added to the present analysis for
completeness.
If the TWOC fails, i.e. the patient requires
re-catheterization, he either undergoes
prostatectomy or is discharged with a
catheter. If the TWOC is successful, the patient
is discharged from hospital, with or with no
alfuzosin. However, some patients may
require BPH surgery during the follow-up for
recurrent AUR or severe symptoms. From
published reports, 5670% of BPH-related
surgery after a successful TWOC is within the
rst 6 months [11,12], although a recent
report showed that TURP may be delayed for
up to 3 years after the rst episode of AUR
[13].
Thus a limit of 6 months follow-up was
chosen for the present model, because this
was the follow-up in ALFAUR study, assuming
that most AUR relapses occur shortly after
the initial episode. The results should be
interpreted considering this relatively short
follow-up.
Data on TWOC success rates with alfuzosin
10 mg one daily and placebo are derived from
the ALFAUR study, a randomized double-
blind, multicentre programme, consisting of
two phases [10]. The rst phase (ALFAUR 1)
assessed the efcacy of alfuzosin 10 mg once
daily in improving the success rate of TWOC.
The second phase (ALFAUR 2) assessed the 6-
month efcacy of alfuzosin in preventing
BPH-related surgery after a successful TWOC.
In all, 363 patients were included in ALFAUR 1.
Alfuzosin was given for an average of 3 days
before the TWOC, which was successful in
61.9% of alfuzosin-treated patients and
47.9% of those on placebo. The relatively high
TWOC success rates in that study, especially in
the placebo arm, may be explained by the
duration of catheterization (mean 55 h). In
ALFAUR 2, 165 patients who successfully
voided at the end of ALFAUR 1 were re-
randomized to receive alfuzosin or placebo for
6 months (182 days). During this period,
17.1% of patients treated with alfuzosin
required BPH surgery, compared to 24.1%
of those treated with placebo [10].
Prostatectomy may be transurethral (TURP) or
open, and these procedures have different
associated costs, which are fully discussed
below [14].
Costs were analysed from the perspective of
the NHS in the UK. The cost gures used in the
model are based on two sources: the National

FIG. 1.

The decision model.
Alfuzosin
Placebo
Immediate
Prostatectomy
Failed
TWOC
Successful
TWOC
Failed
TWOC
Prostatectomy
Prostatectomy
Discharge with
catheter
Prostatectomy
Lifelong catheter
Alfuzosin
Placebo
Prostatectomy
Discharge with
catheter
Prostatectomy
Lifelong catheter
No complications
Prostatectomy
No complications
AUR
A N N E MA N S

E T AL .

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Schedule of Reference Costs from the NHS
Trust (In-Patient DRG Data, 2002) and data on
resource use collected during ALFAUR 2. The
minimum and maximum data provided by the
NHS were used in a Monte Carlo analysis
(Beta distribution). Resource-use data
collected during ALFAUR 2 relate to the
follow-up costs and include GP and urologist
consultations, microbiology, in-hospital
interventions, and outpatient care in the
hospital. Unit costs for these items were
obtained from the NHS. Details of the cost of
follow-up calculations are provided in Table 1.
Costs from 2002 were inated to equivalent
costs in 2003 (inator 1.035). The cost
of follow-up, excluding the required
prostatectomies, was higher in the placebo
group because the resource use was higher,
although not signicantly higher (Table 2).
Some cost items in the model were not readily
available and three calculations were
required. First, the cost of the index
hospitalization if the TWOC failed was
calculated as the weighted average of the
index hospitalization cost of immediate
prostatectomy after failed TWOC (2685) and
the index hospitalization cost of patients who
did not receive immediate prostatectomy. The
latter is similar to the hospitalization cost of a
successful TWOC (718). There is evidence that
2442% of men undergoing prostatectomy in
the UK and USA presented with AUR, and that
many had prostatectomy during the index
hospitalization [1,2]. We therefore assumed
that 24% of patients presenting with AUR
had a prostatectomy during the index
hospitalization. The hospitalization cost of a
TWOC failure was then (2,685

0.24)

+


(718

0.76)

=

1190.
Second, the total 6-month cost after TWOC
failure adds the cost of BPH surgery during
the follow-up of patients discharged with a
catheter to the index hospitalization cost of a
TWOC failure (1190). The cost of BPH surgery
during the follow-up is the weighted average
of TURP (1517) and open prostatectomy
cost (2439). In the UK, according to the
Department of Health (DoH), 63.7% of
prostatectomies for BPH are TURPs [15]. Using
this weight leads to a cost of BPH surgery
after discharge of 1852. The proportion of
prostatectomies after discharge in patients
with a failed TWOC is 76% (see above). Hence,
the estimate for 6-months cost of TWOC
failure is 1190

+

(0.76

1852)

=

2598
Finally, the cost of a prostatectomy during
the follow-up of patients with an initial
successful TWOC is again a weighted average
of TURP and open prostatectomy cost. The
weights are dened as the relative frequency
of TURPs and open prostatectomies as
observed in ALFAUR 2. The proportion of
TURPs is slightly higher in ALFAUR 2 than in
the DoH data; 68% of prostatectomies in
patients with an initial successful TWOC were

TABLE 1

Clinical and cost data applied in the model

Item P (

SEM

) or cost (range) Source

Clinical data

Successful TWOC placebo 0.479 (0.045) ALFAUR [10]
Successful TWOC alfuzosin 0.618 (0.032) ALFAUR [10]
Prostatectomy placebo 0.181 (0.042) ALFAUR [10]
Prostatectomy alfuzosin 0.122 (0.036) ALFAUR [10]
Catheter ad vitam 0.032 (0.022) Klarskov

et al.

[12]
Proportion TURP if prostatectomy 0.68 (0.051) UK DoH

Cost data

Hospitalization cost:
of successful TWOC 718 (518943) NHS
immediate prostatectomy 2685 (20033144) NHS
TWOC failure 1190 (NA) Calculated*
Scheduled TURP 1517 (12651851) NHS
Scheduled open prostatectomy 2439 (17612807) NHS
Prostatectomy in follow-up, TWOC failures 1852 (NA) Calculated*
6-month cost after failed TWOC including
prostatectomy
2598 (NA) Calculated*
Prostatectomy during follow-up, successful
TWOC
1812 (NA) Calculated*
Cost catheter ad vitam rst 6 months 904 (7241169) NHS
Additional costs:
placebo-6 months (extra visits, etc.) 315 (53.22) ALFAUR 2 [10]
alfuzosin-6 months (extra visits, etc.) 151 (36.59) ALFAUR 2 [10]
Alfuzosin cost per unit (10 mg) 0.793 (NA) NHS

*See explanation in text; NA, not available.

TABLE 2

Resource use during the follow-up in ALFAUR 2 (excluding number of prostatectomies)

Alfuzosin Placebo P
N patients 82 83
N (%) of bladders catheterized 11 (13.4) 17 (20.5) 0.30
Mean (

SD

):
N of extra GP visits 0.11 (0.38) 0.10 (0.40) 0.83
N extra urologist visits 0.22 (0.96) 0.38 (1.56) 0.41
N extra tests 0.22 (0.65) 0.31 (0.90) 0.44
Urine culture, n 8 6 0.59
Full blood count, n 1 5 0.21
PSA, n 3 4 1
Ultrasonography, n 3 5 0.72
Ionogram

+

renal function

+

liver tests 2 0 0.16
Prostate biopsy 0 1 0.32
Electrocardiogram 0 1 0.32
Urine analysis 0 2 0.16
Other 1 1 0.99
Other surgical interventions:
Cystostomy 0 1 0.32
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TURP. Thus the weighted average cost of
prostate surgery was (32%

cost open
prostatectomy, 2439)

+

(68%

cost TURP,
1517)

=

1812.
The decision tree was built in Microsoft Excel
and analysed using the built-in software
@Risk v4.5 (Palisade Corporation, Neweld,
NY, USA) allowing probabilistic uncertainty
analysis. A Monte Carlo simulation was run in
@Risk 4.5 to estimate the uncertainty
associated with each cost estimate resulting
from the model. All probabilities and cost data
in the model are characterized by uncertainty,
as expressed in distribution characteristics
(Table 1). This distribution is obviously the
consequence of the fact that the risk for an
event is not equal in all patients and that the
same procedure is not equally expensive in all
patients. When evaluating the model, this
variability in risks and costs is taken into
account. The distributions of the uncertain
model variables (costs and risks) will
determine the distribution of the model
outcomes, in this case the estimates of the
differences in costs between treatment
options. A cost difference between treatment
options is further called an incremental cost.
To evaluate the shape and characteristics of
the incremental cost distribution, a Monte
Carlo procedure simulates many patients
(

n



=

1000) running through the model. At
each simulation, the Monte Carlo procedure
picks a value for each uncertain variable in the
model, taking into account the distribution of
the values, and calculates the incremental
cost resulting from the model. After 1000
simulations, a mean and a 95% CI incremental
cost are produced.

RESULTS

The comparison was between (i) alfuzosin and
placebo, (ii) alfuzosin and immediate
prostatectomy, and (iii) placebo and
immediate prostatectomy. Each comparison
results in an incremental cost estimate. The
calculations of the total costs for all
treatment strategies are shown in Table 3. The
mean incremental costs, their

SD

s and the
95% CIs as derived from the Monte Carlo
simulations based on a rate of 24% of
immediate prostatectomies are presented in
Table 4.
For none of the comparisons did the 95% CIs
contain the zero point; more specically, this
means that the alfuzosin 10 mg once daily is
saving costs (349) relative to placebo and to
immediate prostatectomy (892) with

>

95%
certainty. Moreover, undertaking a TWOC with
no adjunctive medication (placebo) is also
saving costs compared with immediate
prostatectomy (543), with

>

95% certainty. If
the number of patients having an immediate
prostatectomy after a failed TWOC is 42%
(published upper range) instead of the 24%
used in the present base case analysis, savings
with alfuzosin are even higher (399 vs 349).

DISCUSSION

Based on the currently available data of
the ALFAUR study [10] and assuming that
24% of patients will have an immediate
prostatectomy after a failed TWOC, we
conclude that there are signicant cost
savings for the NHS associated with the use
of alfuzosin 10 mg once daily in the
management of AUR. Compared with
immediate prostatectomy, alfuzosin 10 mg
saved signicant costs, with a mean of 892.
Compared with placebo (i.e. watchful
waiting), the mean cost saving was 349. This
saving was even greater (399) if the upper
reported range of immediate prostatectomies
(42%) was considered.
The savings are the result of a combined
signicant acute effect and a trend of reduced
prostate surgery rates in the 6-month follow-
up of a successful TWOC in alfuzosin-treated
patients compared with placebo. The model
did not take into account that in those
patients requiring surgery after a successful
TWOC, it could be done in an elective setting
and therefore be likely to be less costly [9]. If
this had been considered it would have led to
an even larger cost difference between
alfuzosin and the other two treatment
options.
Another aspect not considered was that some
centres may consider a second TWOC before
considering surgery [16]. There are few data
on results of a second TWOC. If we assume
that a second TWOC is not very likely to be
successful, considering it in the decision
model would have contributed to increasing
the costs in the control arm, and hence
favoured alfuzosin.
This analysis is based on economic data
collected during a 6-month period, but in real

TABLE 3

Calculation of total treatment costs (in )

Cost Alfuzosin Placebo Immediate prostatectomy
Of hospitalization before TWOC 718 718 0
Of direct prostatectomy 0 0 2685
3-day drug (3



0.793)

=

2.38 0 0
Unsuccessful TWOC (0.381



2598)

=

990 0.521



2598

=

1353 0
6-month drug 182



0.793



0.619

=

89 0 0
Of scheduled prostatectomy 0.122



0.619



1812

=

137 0.181



0.479



11812

=

157 0
Extra follow-up 0.619



151

=

93 0.479



315

=

151 235
Total 2029 2378 2921

TABLE 4

Incremental costs for 6 months of treatment (in ), based on Monte Carlo simulation

Treatment Incremental cost, mean (

SD

) [95% CI]
Placebo alfuzosin 349 (139) [64624]
Immediate prostatectomy alfuzosin 892 (118) [6441121]
Immediate prostatectomy placebo 543 (132) [228776]
A N N E MA N S

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practice the benet of a successful TWOC may
be maintained for longer. Some patients may
be able to avoid prostate surgery in the
follow-up of a rst AUR episode. Those with
symptoms or signs sufciently severe to
require surgery after a successful TWOC may
be spared the discomfort of having to wait
at home with a urinary catheter until
prostatectomy can be arranged. Also for these
men, there is an added benet of a window of
opportunity for elective prostate surgery,
instead of the day dictated for the operation
dictated being that of the episode of AUR.
These benets are difcult to quantify in cost
terms. Furthermore, it is known that the
presence of a urinary catheter before
prostatectomy increases the risk of infection
and associated events, including septic shock
[17,18]. Thus when applied to very large
numbers of men, perhaps the use of

a

1

-
blockers at the time of AUR may make
prostatectomy slightly safer for some men
and spare for some the need for very
expensive intensive-care treatment. In the
Medical Therapy of Prostate Symptoms study
[19], monotherapy with the

a

1

-blocker
doxazosin over 4 years did not signicantly
reduce the incidence of AUR or prostatic
surgery compared to placebo, whilst
combination with nasteride signicantly
reduced the incidence of both events. Such
data were obtained in a different population,
i.e. men with symptomatic BPH who never
had an episode of AUR, and may not be
extrapolated to the ALFAUR study population.
Meanwhile only the impact on a 6-month
follow-up within the context of the ALFAUR
study can be considered. Factors such as
amount of residual urine at catheter removal
and prostate size predict the need for surgery
for BPH after a TWOC. Applying such
factors in the 6-months period of opportunity
may help to better select men who should
benet from elective (catheter-free) prostate
surgery and those who can continue with
medical treatment and perhaps avoid
prostatectomy altogether. Additional studies
are required to answer these questions.
Poor patient compliance with medication was
not considered in the present model, but we
recognize that perfect compliance is rare [20].
Poor compliance with alfuzosin intake may
have two opposing effects on the costs of
treatment. First, a decrease in the total cost
of alfuzosin, but only if the prescribed
medication is not supplied or purchased.
Second, poor compliance may decrease the
effectiveness of the medication, which leads
to fewer avoided prostatectomies and hence
higher costs. As compliance was not analysed
in the ALFAUR study, it was not possible to
evaluate the clinical consequences of a poor
compliance with alfuzosin.
The present study only assessed healthcare-
related costs to the NHS, using Diagnosis
Related Groups data as the basis for all
calculations. Other cost categories, e.g.
productivity losses (time off work) and non-
medical costs (e.g. patients out-of-pocket
expenses for transport) were not taken into
account. These are especially relevant as
society becomes more interested in the costs
of healthcare. Productivity losses are expected
to be small in this patient age group, as many
are no longer working. The ambulatory costs
(e.g. outpatient specialist visits and GP visits)
as a consequence of TWOC failure are likely to
have been underestimated, and thus the
calculated savings probably underestimate
the true savings of avoiding a TWOC
failure.
Finally, our analysis only considers costs, but if
prostatectomy can be avoided, considering
the small mortality rate associated with this
intervention, a strategy based on a TWOC
associated with alfuzosin treatment may
reduce deaths. Pickard

et al.

[9] reported that
mortality related to prostatectomy was higher
in patients with AUR than in patients who had
an elective prostatectomy (in-hospital
mortality 0.7% vs 0.2%; 90 days out-of-
hospital mortality 4.0% vs 0.7%). When these
values are applied in the model, alfuzosin
intake before and after a TWOC would result
in a 2.75% lower mortality rate than direct
prostatectomy, and in a 0.65% lower
mortality than with placebo. However, these
values must be interpreted cautiously, as the
data from Pickard

et al.

[9] are now at least
17 years old and mortality has decreased
since then.
In conclusion, alfuzosin 10 mg once daily in
patients with AUR, before and after a
successful TWOC, saves costs for the NHS over
the rst 6 months. The required investment in
the pharmaceutical budget is relatively small
compared to the benecial clinical and
economic effects it generates.

CONFLICT OF INTEREST

A. McNeill is a source of funding, paid
consultant to sponsor and study investigator
funded by sponsor. T. Hargreave is a principle
investigator for the ALFAUR study. He was
paid for his time spent co-ordinating this
international study but has received no
payment in relation to the preparation of this
paper. Source of funding: This study was
funded by a research grant from Sano-
Aventis.

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Correspondence: Lieven Annemans, Rue De
Crayer 6, B-1000, Brussels, Belgium.
e-mail: LAnnemans@be.imshealth.com
Abbreviations: AUR, acute urinary retention;
DoH, Department of Health; NHS, National
Health Service (UK); TWOC, trial without
catheter.