Journal of Pediatric Urology (2012) 8, 544e548

Tamsulosin for the management of distal ureteral

stones in children: A prospective randomized study
Ibrahim Mokhless, Abdel-Rahman Zahran, Mohamed Youssif*, Ahmed Fahmy
Section of Pediatric Urology and Endourology, Department of Urology, Alexandria University, Alexandria, Egypt
Received 18 March 2011; accepted 12 September 2011
Available online 17 November 2011

KEYWORDS
Tamsulosin;
Adrenergic alphaantagonists;
Pediatrics;
Urolithiasis

Abstract Purpose: Based on efficacy demonstrated in the adult population, tamsulosin was
evaluated with regard to facilitating ureteral stone expulsion in children presenting with distal
ureteric calculi.
Patients and methods: A prospective randomized controlled study involving 61 children with
distal ureteric calculi <12 mm was performed. The children were randomly divided into two
groups. Group I (study group, n Z 33) received tamsulosin and standard analgesia, and Group
II (placebo group, n Z 28) received standard analgesia and placebo. Patients were offered
a closely monitored trial for spontaneous stone passage in the 4-week period prior to definitive
therapy. The stone expulsion rate, number and duration of pain episodes, need for analgesia
and possible side effects of medications were observed.
Results: All patients completed the study and none were excluded due to side effects. No
significant differences were found between the groups for age, gender and stone size. Mean
patient age was 8.1
6.8 years. There were 25 females and 36 males. The stone-free rate
was 87.8% in Group I (29/33), compared with 64.2% (18/28) in Group II. A mean stone expulsion
time of 8.2 and 14.5 days was recorded for Group I and II respectively, and this difference was
statistically significant (P < 0.001).
Conclusions: Medical expulsion therapy for lower ureteric stones is a successful procedure in
children. Tamsulosin demonstrated no clinically significant adverse effect, while proving to
be a safe and effective treatment option.
2011 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.

Introduction
The incidence and characteristics of urolithiasis in children
reflect a wide geographic variation, but stones occur in

children of all ages without a clear gender predominance.

Although uncommon in the Western hemisphere, pediatric
stone disease is considered endemic in developing nations
[1,2]. The natural history of pediatric stone disease is not as

* Corresponding author. Pediatric Urology Unit, Department of Urology, University of Alexandria School of Medicine, Alexandria, Egypt.
Tel./fax: 20 203 486 0029.
E-mail address: dr.youssif@gmail.com (M. Youssif).
1477-5131/$36 2011 Journal of Pediatric Urology Company. Published by Elsevier Ltd. All rights reserved.
doi:10.1016/j.jpurol.2011.09.008

Tamsulosin for management of distal ureteral stones

well defined as in adulthood, but better understanding of
the pathophysiology of childhood urolithiasis has influenced
the approach over time [3e5]. In the 1980s, the advent of
extracorporeal shock-wave lithotripsy (ESWL) revolutionized pediatric stone management. Currently, it is the
procedure of choice in treating most upper tract calculi.
However, with miniaturization of endoscopes, access to the
entire pediatric urinary tract is possible. If ureteral stones
could be expelled with pharmacotherapy, these procedures
and their associated costs could possibly be avoided [6]. In
the last few years, medical expulsive therapy for ureteral
stones using alpha-adrenergic receptor antagonists (alphablockers) has been developed [7e10]. Ureteral stones tend
to be lodged in the distal part of the ureter and, therefore,
blockage of alpha1-adrenoceptors mostly facilitates stone
passage in adults [11]. Especially in the last decade, the use
of alpha-adrenoceptor antagonists has expanded in pediatric urology to treat neurogenic bladder and lower urinary
tract dysfunction [12]. However, published data are limited
regarding the use of alpha-blockers to manage distal
ureteral stones in children. We conducted a randomized
prospective study to evaluate the efficacy of tamsulosin,
a selective alpha-1-blocker, in promoting spontaneous
passage of distal ureteral stones in children.

Material and methods

After obtaining the approval of the ethical committee in
our center, from April 2007 to July 2010 we prospectively
studied 61 children with radiopaque lower ureteral stones
of 12 mm or smaller. Children with anatomical abnormalities, non-radiopaque stones, voiding dysfunction, urinary
tract infection (UTI), severe hydronephrosis, or history of
endoscopic or open ureteral surgery were excluded. All
patients were evaluated via ultrasound of urinary tract,
plain X-ray of abdomen and pelvis (KUB), and renal function
tests. Non-contrast computerized tomography (NCCT) was
performed in select cases when indicated. Children were
randomly divided into two groups. Group I (study group of
33 children; 18 presented with lower third ureteric calculi
<12 mm, 14 with lower ureteric stone fragment after ESWL,
and 1 with lower ureteric stone fragment after percutaneous nephrolithotomy) received tamsulosin 0.4 mg for
children older than 4 years and 0.2 mg for younger children
at bed time in addition to standard analgesia (ibuprofen).
Those who could swallow the whole capsule were allowed
to do so otherwise the content of the capsule was evacuated in water or juice. Group II (placebo group of 28 children presented with lower third ureteric calculi <12 mm)
received standard analgesia (ibuprofen) and placebo. If
pain was controlled with oral analgesia with no evidence of
UTI, patients were offered a closely monitored trial of
spontaneous passage for 4 weeks prior to definitive treatment. The stone expulsion rate, number and duration of
pain episodes, need for analgesia, and possible side effects
of medications were observed in both groups. To detect
fragments or stone expulsion, parents of all children were
asked to filter the urine. Only patients with no residual
fragments were considered cured. The off-label use of tamsulosin and adverse effects of the medication were discussed
with families and informed consents were received.

545
On follow-up, blood pressure values, pain episodes,
need for analgesics and time to stone expulsion were
noted. The time for spontaneous passage was defined as
the day the parent reported the passage of a stone and the
report was confirmed by absence of the radiopaque calculi
on KUB. If a 4-week treatment failed to expel the stone,
pain was uncontrolled by medications, or fever was documented as a sign of UTI or worsening hydronephrosis, then
definitive treatment whether by ESWL or ureteroscopic
procedures was performed.
The primary endpoint was stone-free rate and time to
stone passage, determined by KUB or NCCT at 4 weeks. The
secondary endpoint was incidence of adverse effects during
the 4-week period. Statistical analyses were carried out
using Fishers exact test and the level of statistical significance was set at P < 0.05.

Results
All patients completed the study and none were excluded
due to side effects. No significant differences were found
between the two groups regarding age, gender and stone
size (Table 1). Mean patient age was 8.1
6.8 (range 2e15
years). There were 25 girls and 36 boys. Stone size was less
than 12 mm with a mean of 7.4 mm (mean
SD
7.4
4.5 mm). The stone-free rate was 87.8% in the study
group (29/33), compared with 64.2% (18/28) in the placebo
group. This difference is statistically significant (P < 0. 01).
A mean stone expulsion time of 8.2 and 14.5 days was
recorded respectively for Group I and II, indicating
a difference of high statistical significance in favor of the
tamsulosin group (Table 2 and Fig. 1).
In Group I, the mean number of pain episodes (1.4
1.2)
was significantly less than in the placebo group (2.2
1.4).
Also, the need for analgesia was less in the tamsulosin
group. None of the patients had any major side effects
while receiving tamsulosin. Blood pressure readings
remained normal at all follow-up visits. One-quarter of
patients treated with tamsulosin reported a mild degree of
somnolence and nasal congestion. Table 3 further illustrates the treatment results as stratified by stone size
(<5 mm, 5e10 mm and >10 mm) in both groups.

Table 1

Characteristics of patients in both groups.

Age (mean
SD) in years

Gender
Male
Female
Stone size (mean
SD) in mm
Stone size (n)
<5 mm
5e10 mm
>10 mm
Stone side
Right
Left

Group I

Group II

7.3
4.2

7.1
3.2

18
15
8.2
2.3

18
10
7.8
3.1

17
13
3

14
13
1

17
16

11
17

546
Table 2

I. Mokhless et al.
Overall results in both groups.

Expulsion rate
Days to expulsion
(mean
SD)
Pain episodes
(mean
SD)
Need for analgesia
(mean
SD)
Side effects (n)
 postural hypotension
 syncope
 palpitations
 somnolence
 headache
 nasal congestion
Total

Group I

Group II

P value

87.8%
8.2
3.4

64.2%
14.5
4.5

<0.01
<0.001

1.4
1.2

2.2
1.4

<0.02

0.7
0.9

1.4
1.1

<0.02

0
0
0
3
1
5
9

0
0
0
2
1
3
6

Discussion
Although uncommon in the Western hemisphere, pediatric
stone disease is considered endemic in developing nations,
including India, Turkey, Pakistan, and the Far East. In these
areas, ammonium acid urate and uric acid stones predominate, strongly implicating dietary factors [1]. Despite this
discrepancy between hemispheres, urolithiasis in children
is increasing in occurrence globally [2], likely reflecting
Westernized lifestyles and dietary changes including higher
salt intake with processed foods and decreased water
consumption. Treatment modalities for ureteral stones
have greatly changed during the last 20 years, especially
following the introduction of minimally invasive procedures
such as ESWL and ureterorenoscopy. Ureteroscopy and
percutaneous nephrolithotomy are being performed on
a wider scale. Although these procedures are effective,
they are not risk free and they have high costs [6].
Conservative management of pediatric urolithiasis
closely mirrors that in adults. Even in very young children,
ureteral calculi <3 mm are likely to spontaneously pass,
and stones 4 mm in the distal ureter are likely to require
endourologic treatment [13,14]. In clinical practice, if
a childs pain is controlled with oral analgesia, clear liquids
are tolerated, and there is no evidence of UTI, parents are

offered a closely monitored trial of spontaneous passage for

3e4 weeks prior to definitive therapy, since most studies
demonstrate stone expulsion in the first 10 days of medical
therapy, and despite complete ureteral obstruction the
kidneys can function without any permanent damage [15].
Spontaneous expulsion of distal ureteral stones depends
on several factors, including size, number and location, as
well as associated smooth muscle spasm and ureteral
edema. Coll et al. found a linear relationship between
stone size and spontaneous expulsion [15]. They indicated
that in adults spontaneous expulsion rates for stones
5e7 mm and greater than 8 mm are 60% and 39%, respectively. The aims of conservative treatment are preventing
muscular spasms, ureteral edema and possible infections,
and reducing pain until spontaneous expulsion occurs
[17,18]. Although ureteral stones have been studied
extensively in adults, it is unknown whether similar treatments can be used for children. Interest in alpha-blockers
stems from the understanding that ureteral smooth
muscle contraction is driven by an increase in intracellular
calcium and is modulated by the autonomic nervous system
[19]. The blockage of alpha1-adrenoceptors by antagonists
decreases spontaneous contractions of the ureteral
musculature. The density of alpha1-adrenoceptors, especially subtype D, is higher in the distal part than in other
areas of the ureter. The advantage of medical expulsive
therapy is important because the risks related to surgical
intervention are not trivial [20]. Studies have reported
overall complication rates after ureteroscopy of 10e20%,
with major complications such as ureteral perforation,
avulsion and stricture occurring in 3e5% of procedures [21].
Many studies have been published on the clinical efficacy of alpha-blockers to promote the passage of distal
ureteral stones in adults since the first report in 2002
[8e10,22,23]. Two meta-analyses provided a high level of
evidence for a clinical benefit of alpha-blockers in patients
with distal ureteral calculi, in which patients given alphablockers had a 52% and 44% greater likelihood of stone
passage than those not given such treatment [3].
In the pediatric population, the non-selective alphablocker phenoxybenzamine and long-acting a1-antagonist
doxazosin have been used to treat dysfunctional voiding
[24,25]. While the reported incidence of hemodynamic
alteration in these prior pediatric studies has not been as
high as in adults, Donohoe et al. [25] found that 75% of
their patients receiving terazosin or doxazosin had mostly

Figure 1 A NCCT of 7-year-old girl with left lower third ureteric stone 10 mm in diameter. B NCCT after passage of this stone with
2 weeks of tamsulosin treatment.

Tamsulosin for management of distal ureteral stones

Table 3

Treatment result as categorized by stone size.

<5 mm

5e10 mm

Expulsion rate: n(%)

Group I
16 (94.1)
11 (84.6)
Group II
11 (87.5)
7 (53.8)
Days to expulsion: (mean
SD)
Group I
7.2
2.0
8.8
0.9
Group II
10
2.9
16.0
1.9

>10 mm
2 (66.6)
0
10.6
1.9
e

central nervous system side effects such as mild degrees

of headache, somnolence and nausea The incidence of
hypotension has been observed to be dose related to
a1-antagonists such as terazosin and doxazosin. The
development of a specific a1A-antagonist with less of
a hemodynamic effect subsequently came about with
tamsulosin. Donohoe et al. [25] first reported the use of
tamsulosin as primary or second-line therapy in children
treated with a variety of a1-anatagonists for primary
bladder neck dysfunction. They reported excellent
success rates with no major adverse effects. The tolerability and variable degrees of efficacy of alpha-blockers in
adults have been well documented [8e10]. Long-term
safety and efficacy of tamsulosin for treatment of
bladder outlet obstruction in the adult population led us
to examine its use in our pediatric population with distal
ureteric stones. We did not have any child or parent
reporting symptoms of postural hypotension, syncope or
palpitation throughout the 4-week duration of treatment.
Side effects observed in the study and placebo groups were
comparable and mild, and no patient withdrew because of
them. Tamsulosin seems to be a safe treatment option for
select children with distal ureteric calculi devoid of any
hemodynamic adverse sequel.
Our study was limited to patients affected by ureteral
stones equal to or smaller than 12 mm Al-Ansari et al. [26]
evaluated the effectiveness of tamsulosin for treating distal
ureteral stones in adults and concluded that it is effective
for stones sized 10 mm or smaller. Our results using tamsulosin for distal ureteral stones in children parallel their
findings. Moreover, we observed a decrease in time to stone
expulsion rate for the treatment group, and the difference
was statistically significant. Few randomized trials have
been carried out to study the impact of alpha-blockers on
the rate of spontaneous passage of distal ureteral stones in
children. Aydogdu et al. [27] showed no significant difference in stone expulsion in children after administration of
doxazosin daily to treat distal ureteral stones of up to
10 mm as compared to analgesic alone. This could be
explained by the relatively small size of the stones in this
study (6.2
1.1 mm). The mean stone size was more than
7.4 mm in both groups of our study population. Differences
in the results could also be attributed to differences in
patients and stone characteristics.
In our study, time to expulsion was significantly shorter
in the tamsulosin group. Miller et al. suggested that
a pediatric ureter is capable of transporting comparatively
larger fragments after lithotripsy [14]. However, as we
included children with distal ureteral stones of up to
12 mm, the potential benefits of alpha-blockers have been

547
more pronounced. Another possible reason that results
were in favor of the tamsulosin group is that the drug
dosage used in the study, which was reported to be effective in adults, was well tolerated in children. The dose
response of alpha-blockers is well known, and higher doses
could possibly demonstrate a significant difference.
Although Lojanapiwat et al. [28] showed that low dose
(0.2 mg daily) and standard dose (0.4 mg daily) tamsulosin
for distal ureter stones produced significantly higher stone
expulsion rates compared to controls, they observed no
significant difference between the two doses. Evaluating
the dose response has provided important information in
our study. Our dose was 0.2 mg daily in children younger
than 4 years and 0.4 mg daily in older children, which is
quite high. Although this dose was safe and tolerable,
different doses should be investigated in future studies to
determine optimum dosage and evaluate the dose response
in separate age groups.
Some prospective randomized studies have revealed that
medical treatment with alpha-blockers of distal ureteral
stones in adults decreases the demand for analgesics and
reduces patient discomfort associated with stone passage
[19]. We observed fewer pain episodes and less need for
analgesics in the treatment group. These results demonstrate that tamsulosin probably decreases the frequency of
phasic peristaltic contractions in the pediatric ureter.
The main limitation of our study is the small number of
patients, which makes stratification by age and gender
difficult. Placebo control has provided information especially about analgesic needs and frequency of pain
episodes. We have demonstrated that tamsulosin therapy in
children had better results regarding the frequency of
episodes of renal colic, the need for analgesics, and its
total dose.
To our knowledge, the present study is the first to show
the efficacy of tamsulosin for spontaneous stone passage in
a pediatric population. Tamsulosin proved to be effective in
facilitating expulsion of ureteral stones in addition to
decreasing time to expulsion.

Conclusion
In this randomized placebo-controlled study, we have
demonstrated that medical expulsion therapy for lower
ureteric stones is a successful procedure in children. Tamsulosin demonstrated no clinically significant adverse
effect, while increasing spontaneous expulsion of distal
ureteral stones in addition to decreasing time to expulsion,
pain episodes, and need for and dose of analgesic in this
pediatric population.

Funding
None.

Conflict of interest
None.

548

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