Int Urol Nephrol (2013) 45:45–51
DOI 10.1007/s11255-012-0377-8
UROLOGY - ORIGINAL PAPER
The effect of first dose of tamsulosin on flow rate
and its predictive ability on the improvement
of LUTS in men with BPH in the mid-term
Yigit Akin • Hakan Gulmez • Murat Ucar •
Selcuk Yucel
Received: 11 December 2012 / Accepted: 27 December 2012 / Published online: 6 January 2013
Ó Springer Science+Business Media Dordrecht 2013
Abstract
Purpose To investigate if effects of the first single
dose of tamsulosin 0.4 mg on uroflowmetry parame-
ters would predict treatment response at the third
month.
Methods Men over 40 years old with complaints of
lower urinary tract symptoms associated with benign
prostatic hyperplasia were studied with physical
examination, urine and blood analysis, uroflowmetry
(UFM), post-voiding residual urine volume (PVR),
international prostate symptom score (IPSS), quality-
of-life (QoL) index and transrectal prostate ultraso-
nography (TRUS), and patients with prostate cancer
suspicion, past urinary surgery, urinary tract infection
and neurologic diseases were excluded. UFM, PVR,
IPSS, QoL were repeated at 6th hour of the first day,
first month and third month of oral tamsulosin 0.4 mg
treatment. All parameters were recorded as baseline,
and changes in the UFM parameters, PVR, IPSS and
QoL were evaluated in clinical visits.
Y. Akin
Department of Urology, Erzincan University School
of Medicine, 24040 Erzincan, Turkey
Y. Akin
M. Ucar
S. Yucel (&)
Department of Urology, Akdeniz University School
of Medicine, 07059 Antalya, Turkey
e-mail: drsyucel@yahoo.com
H. Gulmez
Department of Family Medicine, Baskent University
School of Medicine, 06600 Ankara, Turkey
Results As a total, 48 men (mean 60.17 ± 1.18 years)
were recruited. There was a significant increase in
maximum urine flow rate (Qmax) and average urine flow
rate (Qave) and decrease in PVR from baseline with the
first dose of tamsulosin as well as first and third month of
treatment (p \ 0.05). IPSS and QoL scores significantly
improved at the first month in correlation with UFM
parameters. Tamsulosin treatment was effective in 33
(68.7 %) patients at the first administration and 35
(72.9 %) at the third month. Positive predictive value
and negative predictive value of Qmax change at first dose
for the third month response rate were 90.9 and 66.6 %,
respectively.
Conclusions The mid-term effectiveness of tamsul-
osin may be predicted by changes in UFM parameters
achieved with its first dose.
Keywords Benign prostatic hyperplasia

Lower urinary tract symptoms
Tamsulosin

Uroflowmetry
Introduction
Benign prostatic hyperplasia (BPH), which is a
common cause of lower urinary tract symptoms
(LUTS), is a progressive disease of aging men [1].
Data have suggested that the incidence of symptom-
atic BPH is 23 % in men aged 50 years and 78 % in
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men aged 60–70 years [2]. LUTS related to BPH
influence the quality of life (QoL) with time and hence
require treatment [3].
Pharmacological therapy, minimally invasive treat-
ments such as transurethral microwave therapy and
surgery are the treatment options for BPH. Alpha
blockers are the first step of the treatment in patients
with BPH [4]. Tamsulosin is a highly selective a1a
blocker and also affects a1d-adrenergic receptors
which are in prostate, bladder neck and urethra. Thus,
tamsulosin provides comfortable micturition which
can be measured by uroflowmetry (UFM) parameters
such as maximum urinary flow rate (Qmax) and
average urinary flow rate (Qave) and also improves
QoL. The maximum serum concentration of tamsul-
osin can be measured 6 h after oral administration and
the effectiveness of drug can continue 24 h [5, 6].
However, there are some concerns about the time
interval required to decide whether the a-blocker
treatment is successful or not [7]. This trial has been
claimed to be 1 week–1 month depending on the type
of the a blocker [8].
First dose effect is also another concern for a
blockers. There have been some studies on the effect
of the first dose of a blockers for patients particularly
on acute urinary retention [9]. However, the studies
have suggested contradictory reports for different
alpha blockers [10]. Tamsulosin is known to have the
serum peak levels at the 6th hour but tissue peak levels
can be achieved in 7–10 days [11]. Therefore, single
dose effect of tamsulosin is under debate.
In this study, we aimed to investigate the first dose
effects of tamsulosin on LUTS related to BPH and the
predictive value of the change in UFM parameters at
the first dose of tamsulosin on the improvement of
LUTS symptoms in terms of UFM parameters and
IPSS and QoL index in mid-term.
Methods
This was a prospective, open-label study. All patients
fully understood the treatment and aim of this study,
and also written informed consent was obtained.
Ethical approval for this study was obtained from
our institute and ethics committee.
From July 2005 to January 2006, patients over
40 years old with complaints of LUTS associated
with BPH were recruited from urology outpatient
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Int Urol Nephrol (2013) 45:45–51
clinic at Akdeniz University. Physical examination
including digital rectal examination (DRE), blood
analysis including prostate-specific antigen (PSA),
liver functions and kidney functions (creatinine,
blood urea nitrogen), urinalysis, uroflowmetry
(UFM) (Solar Uroflow, Medical Measurement Sys-
tems, Inc. Dover, NH 03820, USA), and determina-
tion of post-voiding residual urine volume (PVR)
(The BioCon 500, Medline LA, CA 90245, USA),
international prostate symptom score (IPSS), qual-
ity-of-life (QoL) index, transrectal ultrasonography
of prostate (TRUS) with 7.5-MHz probe (Sonoline
SL 450, Siemens AG, Erlangen, Germany) were
performed. Patients who used a blockers and/or 5 a-
reductase inhibitors and/or phytotherapy before;
urinary dysfunction such as neurogenic bladder,
bladder neck sclerosis, urethral stricture, bladder
stone, urinary tract infection, hepatic and/or renal
impairment, severe cardiovascular disease;
PVR [ 100 ml, prostate surgery or other minimally
invasive interventions on prostate, cancer, Alzhei-
mer’s disease, senile dementia and drug hypersen-
sitivity were excluded. Additionally, patients whose
PSA [ 4 ng/dl and/or had rigid nodule in DRE were
excluded for further investigation with prostate
biopsy with TRUS.
As a total, 48 patients’ data were recorded as
baseline. After diagnosis of LUTS associated with
BPH, tamsulosin 0.4 mg once daily was administrated
orally after breakfast to all patients for 3 months.
UFM was performed as a single session. Addition-
ally, PVR of all patients was measured by a single
person (MU). Changes in the UFM parameters such as
Qmax, Qave and also PVR were evaluated in the 6th
hour of the first dose of tamsulosin, first and third
month of the treatment, respectively. IPSS and QoL
were evaluated in the first and third month of the
treatment. All of these parameters were also compared
with baseline parameters.
Descriptive results were reported for all studied
parameters. Paired t tests and Chi-square test were
used for statistical analysis. Univariate and multivar-
iate logistic regression analysis was performed to
identify factors predicting outcomes. Statistical sig-
nificance was considered p \ 0.05 and all p values
were two-sided. All statistical analyses were per-
formed with the Prism Version 5.01 (GraphPad
Software Inc., CA, USA) and graphics were plotted
using the same software.
Int Urol Nephrol (2013) 45:45–51
Results
Mean age of 48 patients was 60.17 ± 1.18 years.
Mean PSA level was 1.97 ± 0.19 ng/dl and mean
prostate volume was 35.77 ± 3.86 cc in TRUS. At the
baseline, mean Qmax was 12.54 ± 4.59 ml/sec, mean
Qave was 5.82 ± 2.18 ml/sec and PVR was
56.31 ± 44.97 ml (Table 1). Mean IPSS was
16.46 ± 5.77 and mean QoL index was 3.67 ± 1.08
(Table 1).
There was a statistically significant increase in
Qmax and Qave and decrease in PVR from baseline at
the first administration of tamsulosin as well as first
and third months of the treatment (p \ 0.05)
(Table 1). Additionally, there was no statistical dif-
ference among after 6th hour, first and third month of
treatment for Qmax, Qave and PVR (p [ 0.05)
(Table 1).
The IPSS and QoL scores significantly increased
from baseline to first and third month of treatment
(p = 0.001). In addition, there was no statistical
difference for IPSS and QoL between first and third
month of treatment (p [ 0.05) (Table 1).
Thirty-three (68.7 %) patients provided benefits
from tamsulosin at 6th hour of the first dose when
compared to the baseline data of Qmax, Qave and PVR
(p \ 0.0001) (Table 2). Additionally, in this tamsul-
osin responsive group, the rates of response to
tamsulosin were correlated with each other for clinic
visits in first and third month as well as in 6th hour of
administration and there was no difference in response
to treatment between first and third month of treatment
(p [ 0.05, p = 0.655) (Fig. 1).
On the other hand, tamsulosin was not effective in
15 (31.3 %) patients after the first administration when
Table 1 Outcomes of uroflowmetry at baseline, after 6th hour, 30th and 90th days of treatment with tamsulosin and primary
efficacy outcomes at baseline and 30th and 90th days of treatment
Parameter (n = 48) Baseline 6th hour
Qmax 12.54 ± 4.59 15.58 ± 6.84
Qave 5.82 ± 2.18 6.95 ± 2.63
PVR 56.31 ± 44.97 48.15 ± 40.25
IPSS 16.46 ± 5.77 – 12.79 ± 6.13
QoL 3.67 ± 1.08 – 2.71 ± 1.13
Data are presented as mean ± SD
Qmax maximum urine flow in uroflowmetry; Qave average urine flow in uroflowmetry; PVR post-voiding residual urine volume; IPSS
international prostatic symptom score; QoL quality of life
* p \ 0.05 significant (vs baseline), paired samples test (T test)
47
compared to baseline data of Qmax, Qave and PVR
(p \ 0.05) (Table 2). In follow-up, these patients
continued to not to respond to tamsulosin in 30th
and 90th day of treatment. Moreover, there was not an
adequate response in 5 of 15 patients for the 30th and
90th days of the treatment (p [ 0.05, p = 0.083).
When we compare the response rates for Qmax
between first dose administration and 90th day,
positive predictive value was 90.9 % and negative
predictive value was 66.6 %. Furthermore, when we
compare the response rates for Qave between first dose
administration and 90th day, positive predictive value
was 86.1 % and negative predictive value was 50 %.
Four patients who did not respond to oral tamsul-
osin treatment underwent transurethral prostate resec-
tion (TURP). Only 1 patient experienced mild
dizziness in the first week of treatment and dizziness
disappeared with time.
Discussion
Benign prostatic hyperplasia usually occurs in men in
their 50s, and 80 % of men in their 70s suffer from
BPH-related LUTS, which is the result of dynamic and
static obstruction [12]. a-Blocker drugs such as
tamsulosin treat the dynamic component of BPH by
blocking a1-receptor-mediated sympathetic stimula-
tion to relax the smooth muscle in the prostate and also
produce their effects on voiding within hours of
administration, regardless of prostate size, without
altering serum prostate-specific antigen or volume
[13]. Tamsulosin is a super-selective subtype a1-a and
-d blocker for the treatment of LUTS associated with
BPH. The standard dose of tamsulosin for BPH is
30th day 90th day p value
16.5 ± 7.81 16.41 ± 7 \0.001*
7.02 ± 2.86 7.24 ± 2.64 \0.001*
38.9 ± 33.4 37.71 ± 32.54 \0.001*
12.15 ± 5.75 0.001*
2.4 ± 1.09 0.001*
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48 Int Urol Nephrol (2013) 45:45–51

Table 2 Compare with baseline and response/not response to tamsulosin in 6th hour
Parameter Response (n = 33, p value) Not response (n = 15, p value)

Mean range from baseline in Qmax 5.49 ml/sn, p \ 0.0001* -1.02 ml/sn, p [ 0.05
Mean range from baseline in Qave 2.01 ml/sn, p \ 0.0001* -0.79 ml/sn, p [ 0.05
Mean range from baseline in PVR 11.7 ml, p \ 0.05* 0.4, p [ 0.05
Qmax Maximum urine flow in uroflowmetry; Qave average urine flow in uroflowmetry; PVR post-voiding residual urine volume
* Statistically significant p value

Fig. 1 The mean and

standard deviation of PVR,
Qmax and Qave in 33 patients
who responded to
tamsulosin

0.4 mg and it is administered once a day orally after
breakfast [14]. Although safety and efficiency of
tamsulosin was provided before, a blockers may not
be effective in long-term period as well as in short-
term [15, 16]. To determine the alpha-blocker treat-
ment effect, a 3-week trial is generally preferred and if
an improvement in IPSS and/or QoL with UFM
parameters is obtained, the treatment is continued until
failure of treatment or patient’s desire for another
therapy [17]. In our study, we used standard dose of
0.4 mg tamsulosin and once daily orally administered
after breakfast for all patients as Michel and de la
Rosetta reported [18]. In our series, we aimed to
investigate whether the first dose of oral tamsulosin
0.4 mg is effective in terms of UFM parameters and
whether the first change of UFM parameters could
predict the mid-term results in terms of UFM param-
eters and IPSS and QoL indices. Our uncontrolled
prospective study presents that the first dose of
tamsulosin 0.4 mg is effective to improve UFM
parameters immediately and also can predict the
mid-term change in UFM parameters as well as IPSS
and QoL indices in the treatment of BPH-related
LUTS.
In our series, we used a selected population that
suffers from ‘‘moderate LUTS’’ (mean IPSS of
16.46 ± 5.77) and relatively young mean age of
60 years (mean age 60.17 ± 1.18 years). This was an
ideal population for treatment with alpha blockade
[18, 19]. We preferred to study the UFM at the 6th
hour of the first dose since the peak serum level of
tamsulosin occurs at 6 h. However, the tissue level
occurs at the 7.6–10.9 days with continuous medica-
tion [19, 20]. Tamsulosin 0.4 mg is one of the most
widely used drugs in the treatment of LUTS associated
with BPH and it is well established that tamsulosin is
relatively uroselective for a-1A and -1D adrenocep-
tors over a-1B adrenoceptors in prostate, bladder neck
and bladder [21, 22]. Tamsulosin formulation has an
absorption profile that depends on food intake, and is
associated with low levels of intestinal absorption.
Additionally, serum level of tamsulosin depends on
food and gastrointestinal transit time, resulting in
70 % higher serum levels when taken on an empty
stomach compared to after a meal [23]. After oral
administer of tamsulosin, drug is absorbed from
intestine and carried by plasma proteins in serum
and also bioavailable of tamsulosin is nearly 100 %.

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Int Urol Nephrol (2013) 45:45–51
Tamsulosin is extensively metabolized by cytochrome
p-450 in the liver [24]. Tamsulosin is eliminated 5–7 h
and approximately 10 % is excreted unchanged in
urine. Korstanje et al. [19] reported calculation on
unbound tamsulosin, a ratio of 63 resulted for prostate
and plasma maximum concentrations. Therefore, as
Korstanje et al. reported, our results are parallel with
them; response rate for tamsulosin treatment was
statistically significant in the first day at the 6th hour as
well as first and third month of treatment according to
tamsulosin metabolism in men [19]. These findings
provide us rapid effects clinically as results of our
series supported. However, we have not looked into its
efficacy on acute urinary retention. In this series, we
investigated whether this rapid effectiveness of tam-
sulosin would continue in mid-term.
We determined statistically significant increase in
Qmax and Qave and decrease in PVR for 33 (68.7 %)
patients from baseline at the first dose of tamsulosin
as well as first and third month of the treatment. At
the third month, all patients continued to have
improved UFM parameters and IPSS and QoL index.
Whereas in the remaining 15 (31.3 %) men with no
improvement in UFM parameters at the first dose,
only 2 of them had an improvement in the UFM
parameters at the third month. This represents that
first dose might predict the improvement at the third
month. Overall, tamsulosin 0.4 mg treatment was
effective in 35 men (72.9 %), was effective in
increasing Qmax and Qave, and decrease in PVR and
IPSS at the third month. These results are parallel to
Chung et al. [25]. However, they used 0.2–0.4 mg of
tamsulosin and both were effective for LUTS related
with BPH. Although there are some studies that
0.2 mg tamsulosin was effective for BPH in Korean
patients, there is no study for exact effective dose of
tamsulosin in BPH patients in Turkey [26]. In our
series, there was a good response for tamsulosin with
a selected population.
We found the positive predictive value of the first
dose Qmax change for third month Qmax improvement
as 90.9 % and negative predictive value as 66.6 %.
Furthermore positive predictive value for Qave was
86.1 % and negative predictive value was 50 %. In
light of these findings, at the first dose of tamsulosin
0.4 mg, if the change in Qmax was at the least ?5 ml/
sec and in Qave at the least ?2 ml/sec, we may predict
that tamsulosin would be effective at the third month.
Similarly, if the decrease was -11 ml in PVR at the
49
first dose, we may mention that there would have been
response to tamsulosin treatment at the third month.
Mean prostate volume was 35.77 ± 3.86 in trans-
rectal USG. Moreover, according to our results,
prostate volume, age, PSA, baseline IPSS, baseline
UFM parameters such as Qmax, Qave and also PVR
were not associated with response to tamsulosin
treatment in multivariate regression analysis
(p [ 0.05) (Table 3). These findings are parallel with
Kang et al. [27], especially, response to tamsulosin
treatment was not associated with prostate volume in
our series like Kang et al. [27]. Additionally, these
finding may support that a-blocker drugs such as
tamsulosin is the first step of treatment in patients with
BPH.
There was statistically significant increase in IPSS
and QoL scores from baseline to first and third month
of treatment. These results are similar like the report of
Djavan et al. [28]. Tamsulosin improves both voiding
and storage symptoms by inhibiting the detrusor
muscle contraction by blocking a-1a and -d adreno
receptors in urethra and bladder [29]. However, IPSS
does not contain any objective information; it is
associated with obstructive symptoms [30]. In our
study, changes in IPSS and QoL scores were statisti-
cally significant in clinical visits. The IPSS and QoL
scores were correlated with UFM parameters and PVR
in 33 patients whom tamsulosin resolved obstructive
symptoms (Table 1) (p \ 0.05).
There are some limitations in our study. Firstly, this
is an uncontrolled study and we cannot escape from its
drawbacks. However, our overall results are parallel
Table 3 Evaluation for response to tamsulosin treatment in
multivariate regression analysis
Parameter p value
Age 0.113
Baseline IPSS 0.106
Baseline Qmax 0.270
Baseline Qave 0.632
Baseline PVR 0.207
Prostate volume 0.134
PSA 0.707
IPSS internationale prostate symptom score; Qmax maximum
urine flow in uroflowmetry; Qave average urine flow in
uroflowmetry; PVR post-voiding residual urine volume; PSA
prostate-specific antigen
* Statistically significant p value
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with the literature [27]. Secondly, UFM study has been
performed only once particularly at the first dose.
UFM should be repeated at least three times at
different days for a reliable result [11]. However,
since we were investigating the first dose results at the
6th hour, only one UFM study was possible. Another
limitation is that we could not elongate the study for
the long term due to patient compliance problems. In
our community, patients with BPH tend to change the
medication frequently since even family doctors can
prescribe a blockers or other drugs such as phytother-
apy and 5 a-reductase inhibitors.
Conclusions
Tamsulosin 0.4 mg once daily is a rapidly effective
and safe treatment for LUTS related with BPH and
also improves UFM parameters in the first day of
treatment. To predict the mid-term efficacy of tam-
sulosin, it may be possible with using the change in
UFM parameters at the first dose of tamsulosin.
Acknowledgments This project has been supported by
Akdeniz University Scientific Research and Project Units.
Conflict of interest The authors have no conflict of interests.
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