The Journal of International Medical Research

2010; 1436 – 1441 [first published online as 38(4) 13]

Efficacy of Tamsulosin 0.4 mg/day in

Relieving Double-J Stent-related
Symptoms: a Randomized Controlled
Study
N NAVANIMITKUL AND B LOJANAPIWAT
Division of Urology, Department of Surgery, Faculty of Medicine, Chiang Mai University,
Chiang Mai, Thailand

This study evaluated the efficacy of
tamsulosin in improving stent-related
symptoms and quality of life in patients
with in-dwelling double-J ureteral stents.
A total of 42 patients (15 males and 27
females) with ureteral stent placement
following ureteroscopy, percutaneous
nephrolithotomy or balloon dilatation,
were prospectively randomized into two
groups of 21 patients. Group I received
0.4 mg tamsulosin once daily for 4 weeks
and group II was a non-placebo, non-
treatment control. All patients
completed the International Prostate
Symptom Score (IPSS) and SF-36
questionnaires at 2 and 4 weeks post-
operatively. The IPSS scores for irritative
and obstructive symptoms were
significantly lower in group I than group
II at both 2 and 4 weeks. Among the
eight domains of SF-36, role limitation
due to physical health and bodily pain
was significantly better in group I at 2
and 4 weeks. General health was also
significantly better in group I at 2 weeks.
Tamsulosin improved both urinary
symptoms and quality of life without
causing serious side-effects.

KEY WORDS: TAMSULOSIN; a1-ADRENOCEPTOR ANTAGONIST; URETERAL STENT; QUALITY OF LIFE;

STENT-RELATED SYMPTOMS

Introduction encrustation and fragmentation of the

Ureteral stent placement is an increasingly
common procedure in urological practice,
due to growth in endourological surgery and
extracorporeal shock wave lithotripsy.1
Ureteral stent placement is also indicated
following ureteral reconstructive surgery and
as urinary diversion in patients with acute
obstruction from ureteral stones.
Complications following stent placement
include stent-related symptoms, migration,
stent.2,3 The degree of complications varies
among patients, but commonly affect
quality of life.2 – 4
α1-Adrenoceptors have been found in the
human ureter, with the highest density in the
distal ureter.5 α1-Adrenoceptor antagonists
dilate the lumen and reduce spasms by
inhibiting basal tone and peristaltic
frequency of the ureter, which may improve
stent-related symptoms.6 Tamsulosin is a

1436
 N Navanimitkul, B Lojanapiwat
Tamsulosin for relieving stent-related symptoms
selective α1A- and α1D-adrenoceptor
antagonist, relaxing smooth muscle in the
prostate, bladder neck and distal ureter.7 It is
generally used for the treatment of benign
prostatic hyperplasia, but there are several
reports on its use in the treatment of distal
ureteric stones.8 – 11 In the present study, the
effect of tamsulosin in improving double-J
stent-related symptoms and quality of life
following ureteral stent placement was
studied.
Patients and methods
PATIENTS
Patients who underwent ureteroscopy,
percutaneous nephrolithotomy or retrograde
balloon dilatation with post-operative
double-J stent insertion at Chiang Mai
University Hospital in Thailand between
January 2008 and June 2009 were enrolled.
Those who had open surgery, bilateral stent
insertion, benign prostatic hyperplasia-
related lower urinary tract symptoms,
history of chronic prostatitis, prostate cancer,
or history of chronic α-blocker or analgesic
drug use were excluded.
The study was approved by the
Institutional Review Board of Chiang Mai
University, Thailand and patients signed
informed consent before participating. All
patients were fully informed regarding the
potential side effects of tamsulosin.
STENT INSERTION
Blood creatinine was measured in all
patients before the surgery. All patients were
inserted for 4 weeks with identical double-J
flexible, variable length, size 6F stents
consisting of biocompatible polyurethane
with a HydroPlus™ coating (Microvasive,
stretch VL; Boston Scientific, Natick, MA,
USA). Insertion occurred under regional or
general anaesthesia and correct positioning
was confirmed by plain abdominal X-ray.
1437
No patient had any complications from the
procedure.
STUDY DESIGN
Patients were prospectively randomized by
random-number table into two groups.
Group I received tamsulosin (Harnal®;
Astellas Pharma Inc., Tokyo, Japan) 0.4
mg/day for 4 weeks. Group II was the control
and received neither tamsulosin nor placebo.
All patients received ofloxacin 200 mg twice
a day for 5 days and paracetamol
(acetaminophen) on demand.
URINARY TRACT SYMPTOM
ASSESSMENT
The International Prostate Symptom Score
(IPSS) questionnaire12 was used to assess
patients’ symptoms at 2 and 4 weeks post-
operatively. The IPSS questionnaire consists
of seven questions, four relating to voiding
(obstructive) symptoms and three to storage
(irritative) symptoms. Responses were graded
on a five-point rating scale. The maximum
scores for voiding and storage symptoms are
20 and 15, respectively; the higher the score,
the worse are the symptoms.
QUALITY OF LIFE ASSESSMENT
Quality of life (QofL) was assessed at 2 and 4
weeks post-operatively, using the QofL
section of the IPSS questionnaire and short
form 36 (SF-36).13 The SF-36 evaluates
patients in eight health status domains,
including physical functioning, role
limitations due to physical health or
emotional problems, vitality, mental health,
social functioning, bodily pain and general
health perceptions. Each domain comprises
several questions and the responses are
tallied to allocate a total score.
STATISTICAL ANALYSES
Data were analysed using χ2 and Student’s t-
 N Navanimitkul, B Lojanapiwat
Tamsulosin for relieving stent-related symptoms

tests with SPSS® statistical software, version
17.0 (SPSS Inc., Chicago, IL, USA). A P-value
< 0.05 was considered statistically
significant.
Results
The study included 42 patients (15 men and
27 women) of which 21 (50%) had ureteral
stents inserted following ureteroscopy, 13
(31%) following percutaneous nephro-
lithotomy and eight (19%) following ureteral
balloon dilatation. Patient demographic
data were comparable between the two
groups (Table 1). None of the patients had
any lower urinary tract symptoms prior to
the start of the study.
Table 2 shows the results of patient
questionnaires regarding urinary tract
symptoms and QofL at 2 and 4 weeks post-
operatively. The IPSS irritative symptom and
obstructive symptom scores were
significantly lower in group I (tamulosin
treated) than group II (control) at both time
points (week 2, P ≤ 0.044; week 4, P ≤ 0.003).
Of the eight domains of the SF-36, role
limitation due to physical health and bodily
pain were significantly better in group I than
group II at both time points (week 2, P ≤
0.002; week 4, P ≤ 0.028). General health was
significantly worse at week 2 in the control
group. There were no significant differences
in any of the other parameters measured.
All patients completed the 4-week study.
Tamsulosin was well tolerated with two
patients (9.52%) experiencing mild side-
effects, such as dizziness and headache.
Discussion
The double-J stent is a common tool used in
urological surgery.1 Despite improved design
and materials, many patients still develop
stent-related symptoms, sometimes
necessitating early removal.14 – 17 Candela
and Bellman16 found that stent diameter
and composition (including 6F Percuflex®, 6F
HydroPlus™ and 4.8F HydroPlus™) did not
affect double-J stent-related symptoms, such
as haematuria. The aetiology of double-J

TABLE 1:
Characteristics of the 41 patients who underwent ureteroscopy, percutaneous
nephrolithotomy or retrograde balloon dilatation with post-operative double-J stent
insertion stratified according to whether they received tamulosin 0.4 mg/day for 4 weeks
(tamulosin, group I) or neither tamsulosin nor placebo (group II, control)
Characteristic Tamulosin (group I) Control (group II)
Patients, n 21 21
Age (years)
Mean 46.1 51.5
Range (24 – 64) (35 – 71)
Gender, n
Male 9 6
Female 12 15
Indication, n
Ureteroscopy 12 9
Percutaneous nephrolithotomy 4 9
Balloon dilatation 5 3
Employed, n (%) 14 (66.66) 15 (71.43)
Creatinine, mg/dl 1.23 1.20
No statistically significant between-group differences (P > 0.05).

1438
 N Navanimitkul, B Lojanapiwat
Tamsulosin for relieving stent-related symptoms

TABLE 2:
Results of the International Prostate Symptom Score (IPSS) and short form 36 (SF-36)
questionnaires used to assess symptoms at 2 and 4 weeks after double-J stent insertion
according to whether patients received tamulosin 0.4 mg/day for 4 weeks (tamulosin,
group I) or neither tamsulosin nor placebo (group II, control)
Tamsulosin Control Statistical
Variable (group I) (group II) significance
IPSS (2 weeks)
Irritative symptoms 5.48 (3.91 – 7.04) 7.81 (6.07 – 9.55) P = 0.044
Obstructive symptoms 1.38 (0.28 – 2.48) 4.86 (3.43 – 6.28) P < 0.001
Quality of life 1.71 (1.10 – 2.33) 3.38 (2.76 – 3.99) P < 0.001
IPSS (4 weeks)
Irritative symptoms 3.81 (2.66 – 4.96) 8.19 (6.90 – 9.48) P < 0.001
Obstructive symptoms 1.24 (0.38 – 2.10) 4.00 (2.40 – 5.60) P = 0.003
Quality of life 1.62 (1.20 – 2.04) 2.86 (2.31 – 3.40) P < 0.001
SF-36 (2 weeks)
Physical functioning 0.82 (0.74 – 0.90) 0.71 (0.63 – 0.79) NS
Role limitations due to physical
health 0.65 (0.53 – 0.77) 0.39 (0.28 – 0.49) P < 0.001
Role limitations due to emotional
problems 0.72 (0.59 – 0.85) 0.79 (0.68 – 0.91) NS
Vitality 0.70 (0.63 – 0.77) 0.60 (0.51 – 0.70) NS
Mental health 0.81 (0.73 – 0.88) 0.72 (0.63 – 0.81) NS
Social functioning 0.94 (0.87 – 1.00) 0.83 (0.71 – 0.95) NS
Bodily pain 0.66 (0.53 – 0.71) 0.47 (0.37 – 0.57) P = 0.002
General health 0.62 (0.53 – 0.71) 0.49 (0.40 – 0.58) P = 0.042
SF-36 (4 weeks)
Physical functioning 0.84 (0.78 – 0.91) 0.76 (0.69 – 0.83) NS
Role limitations due to physical
health 0.67 (0.55 – 0.79) 0.48 (0.36 – 0.60) P = 0.028
Role limitations due to emotional
problems 0.86 (0.76 – 0.95) 0.74 (0.61 – 0.87) NS
Vitality 0.73 (0.65 – 0.81) 0.65 (0.57 – 0.73) NS
Mental health 0.81 (0.74 – 0.89) 0.72 (0.63 – 0.81) NS
Social functioning 0.93 (0.86 – 1.00) 0.85 (0.72 – 0.97) NS
Bodily pain 0.71 (0.63 – 0.79) 0.52 (0.43 – 0.61) P = 0.002
General health 0.63 (0.53 – 0.72) 0.52 (0.43 – 0.61) NS
NS, not statistically significant (P > 0.05).

stent-related symptoms can be explained by prospective, randomized study comparing

multiple factors such as trigone, ureteral and
renal irritation, and pressure between the
bladder and renal pelvis.14 – 17 It is known
that α1D receptors are present in the ureter,6
and that α-blockers relieve double-J stent-
related symptoms by decreasing ureteral
spasm, trigone sensitivity and urine reflux
during voiding.6 Wang et al.18 reported a
tamsulosin with placebo in 79 patients with
double-J stents and found that tamsulosin
improved stent-related symptoms and
quality of life, and could be applied in
routine clinical practice. Damiano et al.19
demonstrated the positive effect of
tamsulosin 0.4 mg once daily in improving
stent-related urinary symptoms and pain

1439
 N Navanimitkul, B Lojanapiwat
Tamsulosin for relieving stent-related symptoms

after 1 week in 75 patients (38 of whom
received tamulosin) implanted with 7F
ureteral stents following ureteroscopy with
ballistic lithotripsy.
The effect of the α-blocker, alfuzosin, was
studied in patients inserted with double-J
ureteral stents for unilateral ureteral stone-
related hydronephrosis.6 When assessed with
the ureteral stent symptom questionnaire
(USSQ), patients who received alfuzosin 10
mg/day had better urinary symptom, pain
and general health index scores than those
who received placebo. These patients also
had less pain and lower analgesic use. Joshi
et al.20 reported the clinical use of the USSQ
for evaluation of quality of life after ureteral
stent placement. Among 62 patients who
completed the questionnaire, up to 80%
experienced stent-related problems that
affected their work performance, general
health and quality of life, with the most
bothersome symptoms being storage
problems and incontinence.
The present study minimized within-study
variations by using identical stents during
endourological surgery. All patients tolerated
the indwelling stents for the 4 weeks’ post-
operative study period. The IPSS irritative
and obstructive symptom scores at 2 and 4
weeks were significantly lower and the QofL
scores were significantly better in patients
who received tamsulosin compared with the
control group. The limitations of this study
are that it was not blinded and had no
placebo control; there may have been a
placebo effect in patients who received the
active drug.
Acknowledgement
The authors wish to thank Shirani
Kanaganayagam for her assistance in
preparing the manuscript.
Conflicts of interest
The authors had no conflicts of interest to
declare in relation to this article.

• Received for publication 24 December 2009 • Accepted subject to revision 13 January 2010
• Revised accepted 24 March 2010
Copyright © 2010 Field House Publishing LLP

References double-J stent-related symptoms? Urology 2006;

1 Chew BH, Knudsen BE, Denstedt JD: The use of
stents in contemporary urology. Curr Opin Urol
2004; 14: 111 – 115.
2 Joshi HB, Newns N, Stainthorpe A, et al:
Ureteral stent symptom questionnaire:
development and validation of a α1D-adrenergic receptor antagonist tamsulosin.
multidimensional quality of life measure. J Urol
2003; 169: 1060 – 1064.
3 Richter S, Ringel A, Shalev M, et al: The
indwelling ureteric stent: a ‘friendly’ procedure
with unfriendly high morbidity. BJU Int 2000;
85: 408 – 411.
4 Joshi HB, Stainthorpe A, Keeley FX Jr, et al:
Indwelling ureteral stents: evaluation of quality
of life to aid outcome analysis. J Endourol 2001;
15: 151 – 154.
5 Sigala S, Dellabella M, Milanese G, et al:
Evidence for the presence of α1 adrenoceptor
subtypes in the human ureter. Neurourol Urodyn
2005; 24: 142 – 148.
6 Deliveliotis C, Chrisofos M, Gougousis E, et al: Is
there a role for alpha1-blockers in treating
67: 35 – 39.
7 Bouchelouche K, Andersen L, Alvarez S, et al:
Increased contractile response to
phenylephrine in detrusor of patients with
bladder outlet obstruction: effect of the α1A and
J Urol 2005; 173: 657 – 661.
8 Michel MC, Mehlbuurger L, Bressel HU, et al:
Tamsulosin treatment of 19,365 patients with
lower urinary tract symptoms: does co-
morbidity alter tolerability? J Urol 1998; 160:
784 – 791.
9 Schulman CC, Lock TM, Buzelin JM, et al: Long-
term use of tamsulosin to treat lower urinary
tract symptoms/benign prostatic hyperplasia. J
Urol 2001; 166: 1358 – 1363.
10 Küpeli B, Irkilata L, Gürocak S, et al: Does
tamsulosin enhance lower ureteral stone
clearance with or without shock wave
lithotripsy? Urology 2004; 64: 1111 – 1115.
11 Porpiglia F, Ghignone G, Fiori C, et al:
Nifedipine versus tamsulosin for the

1440
 N Navanimitkul, B Lojanapiwat
Tamsulosin for relieving stent-related symptoms

management of lower ureteral stones. J Urol
2004; 172: 568 – 571.
12 Cockett ATK, Aso Y, Denis L, et al on behalf of
the members of the committees:
Recommendations of the International
Consensus Committee. In: Proceedings of The
Second International Consultation on Benign
Prostatic Hyperplasia (BPH) (Cockett ATK, Aso Y,
Chatelain C, et al, eds). Paris: Pitié Salpêtrière,
1993; pp553 – 564.
13 Ziebland S: The short form 36 health status
questionnaire: clues from the Oxford region’s
normative data about its usefulness in
measuring health gain in population surveys. J
Epidemiol Community Health 1995; 49: 102 –
105.
14 Denstedt JD, Reid G, Sofer M: Advances in
ureteral stent technology. World J Urol 2000; 18:
237 – 242.
15 Beiko DT, Knudsen BE, Denstedt JD: Advances
in ureteral stent design. J Endourol 2003; 17: 195
– 199.
16 Candela JV, Bellman GC: Ureteral stents:
impact of diameter and composition on patient
symptoms. J Endourol 1997; 11: 45 – 47.
17 Thomas R: Indwelling ureteral stents: impact of
material and shape on patient comfort. J
Endourol 1993; 7: 137 – 140.
18 Wang CJ, Huang SW, Chang CH: Effects of
specific α-1A/1D blocker on lower urinary tract
symptoms due to double-J stent: a prospectively
randomized study. Urol Res 2009; 37: 147 – 152.
19 Damiano R, Autorino R, De Sio M, et al: Effect
of tamsulosin in preventing ureteral stent-
related morbidity: a prospective study. J
Endourol 2008; 22: 651 – 656.
20 Joshi HB, Stainthorpe A, MacDonagh RP, et al:
Indwelling ureteral stents: evaluation of
symptoms, quality of life and utility. J Urol
2003; 169: 1065 – 1069.

Author’s address for correspondence:

Dr B Lojanapiwat
Division of Urology, Department of Surgery, Faculty of Medicine, Chiang Mai University,
Chiang Mai, Thailand.
E-mail: blojanap@mail.med.cmu.ac.th

1441