Efficacy of Tamsulosin 0.4 mg/day in Relieving Double-J Stent-related Symptoms: a Randomized Controlled Study
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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 Symptom Score (IPSS) and SF-36
tamsulosin in improving stent-related questionnaires at 2 and 4 weeks post-
symptoms and quality of life in patients operatively. The IPSS scores for irritative
with in-dwelling double-J ureteral stents. and obstructive symptoms were
A total of 42 patients (15 males and 27 significantly lower in group I than group
females) with ureteral stent placement II at both 2 and 4 weeks. Among the
following ureteroscopy, percutaneous eight domains of SF-36, role limitation
nephrolithotomy or balloon dilatation, due to physical health and bodily pain
were prospectively randomized into two was significantly better in group I at 2
groups of 21 patients. Group I received and 4 weeks. General health was also
0.4 mg tamsulosin once daily for 4 weeks significantly better in group I at 2 weeks.
and group II was a non-placebo, non- Tamsulosin improved both urinary
treatment control. All patients symptoms and quality of life without
completed the International Prostate 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 stent.2,3 The degree of complications varies
common procedure in urological practice, among patients, but commonly affect
due to growth in endourological surgery and quality of life.2 – 4
extracorporeal shock wave lithotripsy.1 α1-Adrenoceptors have been found in the
Ureteral stent placement is also indicated human ureter, with the highest density in the
following ureteral reconstructive surgery and distal ureter.5 α1-Adrenoceptor antagonists
as urinary diversion in patients with acute dilate the lumen and reduce spasms by
obstruction from ureteral stones. inhibiting basal tone and peristaltic
Complications following stent placement frequency of the ureter, which may improve
include stent-related symptoms, migration, stent-related symptoms.6 Tamsulosin is a
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Tamsulosin for relieving stent-related symptoms
selective α1A- and α1D-adrenoceptor No patient had any complications from the
antagonist, relaxing smooth muscle in the procedure.
prostate, bladder neck and distal ureter.7 It is
generally used for the treatment of benign STUDY DESIGN
prostatic hyperplasia, but there are several Patients were prospectively randomized by
reports on its use in the treatment of distal random-number table into two groups.
ureteric stones.8 – 11 In the present study, the Group I received tamsulosin (Harnal®;
effect of tamsulosin in improving double-J Astellas Pharma Inc., Tokyo, Japan) 0.4
stent-related symptoms and quality of life mg/day for 4 weeks. Group II was the control
following ureteral stent placement was and received neither tamsulosin nor placebo.
studied. All patients received ofloxacin 200 mg twice
a day for 5 days and paracetamol
Patients and methods (acetaminophen) on demand.
PATIENTS
Patients who underwent ureteroscopy, URINARY TRACT SYMPTOM
percutaneous nephrolithotomy or retrograde ASSESSMENT
balloon dilatation with post-operative The International Prostate Symptom Score
double-J stent insertion at Chiang Mai (IPSS) questionnaire12 was used to assess
University Hospital in Thailand between patients’ symptoms at 2 and 4 weeks post-
January 2008 and June 2009 were enrolled. operatively. The IPSS questionnaire consists
Those who had open surgery, bilateral stent of seven questions, four relating to voiding
insertion, benign prostatic hyperplasia- (obstructive) symptoms and three to storage
related lower urinary tract symptoms, (irritative) symptoms. Responses were graded
history of chronic prostatitis, prostate cancer, on a five-point rating scale. The maximum
or history of chronic α-blocker or analgesic scores for voiding and storage symptoms are
drug use were excluded. 20 and 15, respectively; the higher the score,
The study was approved by the the worse are the symptoms.
Institutional Review Board of Chiang Mai
University, Thailand and patients signed QUALITY OF LIFE ASSESSMENT
informed consent before participating. All Quality of life (QofL) was assessed at 2 and 4
patients were fully informed regarding the weeks post-operatively, using the QofL
potential side effects of tamsulosin. section of the IPSS questionnaire and short
form 36 (SF-36).13 The SF-36 evaluates
STENT INSERTION patients in eight health status domains,
Blood creatinine was measured in all including physical functioning, role
patients before the surgery. All patients were limitations due to physical health or
inserted for 4 weeks with identical double-J emotional problems, vitality, mental health,
flexible, variable length, size 6F stents social functioning, bodily pain and general
consisting of biocompatible polyurethane health perceptions. Each domain comprises
with a HydroPlus™ coating (Microvasive, several questions and the responses are
stretch VL; Boston Scientific, Natick, MA, tallied to allocate a total score.
USA). Insertion occurred under regional or
general anaesthesia and correct positioning STATISTICAL ANALYSES
was confirmed by plain abdominal X-ray. Data were analysed using χ2 and Student’s t-
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Tamsulosin for relieving stent-related symptoms
tests with SPSS® statistical software, version Of the eight domains of the SF-36, role
17.0 (SPSS Inc., Chicago, IL, USA). A P-value limitation due to physical health and bodily
< 0.05 was considered statistically pain were significantly better in group I than
significant. group II at both time points (week 2, P ≤
0.002; week 4, P ≤ 0.028). General health was
Results significantly worse at week 2 in the control
The study included 42 patients (15 men and group. There were no significant differences
27 women) of which 21 (50%) had ureteral in any of the other parameters measured.
stents inserted following ureteroscopy, 13 All patients completed the 4-week study.
(31%) following percutaneous nephro- Tamsulosin was well tolerated with two
lithotomy and eight (19%) following ureteral patients (9.52%) experiencing mild side-
balloon dilatation. Patient demographic effects, such as dizziness and headache.
data were comparable between the two
groups (Table 1). None of the patients had Discussion
any lower urinary tract symptoms prior to The double-J stent is a common tool used in
the start of the study. urological surgery.1 Despite improved design
Table 2 shows the results of patient and materials, many patients still develop
questionnaires regarding urinary tract stent-related symptoms, sometimes
symptoms and QofL at 2 and 4 weeks post- necessitating early removal.14 – 17 Candela
operatively. The IPSS irritative symptom and and Bellman16 found that stent diameter
obstructive symptom scores were and composition (including 6F Percuflex®, 6F
significantly lower in group I (tamulosin HydroPlus™ and 4.8F HydroPlus™) did not
treated) than group II (control) at both time affect double-J stent-related symptoms, such
points (week 2, P ≤ 0.044; week 4, P ≤ 0.003). 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).
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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 tamsulosin with placebo in 79 patients with
renal irritation, and pressure between the double-J stents and found that tamsulosin
bladder and renal pelvis.14 – 17 It is known improved stent-related symptoms and
that α1D receptors are present in the ureter,6 quality of life, and could be applied in
and that α-blockers relieve double-J stent- routine clinical practice. Damiano et al.19
related symptoms by decreasing ureteral demonstrated the positive effect of
spasm, trigone sensitivity and urine reflux tamsulosin 0.4 mg once daily in improving
during voiding.6 Wang et al.18 reported a stent-related urinary symptoms and pain
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Tamsulosin for relieving stent-related symptoms
after 1 week in 75 patients (38 of whom The present study minimized within-study
received tamulosin) implanted with 7F variations by using identical stents during
ureteral stents following ureteroscopy with endourological surgery. All patients tolerated
ballistic lithotripsy. the indwelling stents for the 4 weeks’ post-
The effect of the α-blocker, alfuzosin, was operative study period. The IPSS irritative
studied in patients inserted with double-J and obstructive symptom scores at 2 and 4
ureteral stents for unilateral ureteral stone- weeks were significantly lower and the QofL
related hydronephrosis.6 When assessed with scores were significantly better in patients
the ureteral stent symptom questionnaire who received tamsulosin compared with the
(USSQ), patients who received alfuzosin 10 control group. The limitations of this study
mg/day had better urinary symptom, pain are that it was not blinded and had no
and general health index scores than those placebo control; there may have been a
who received placebo. These patients also placebo effect in patients who received the
had less pain and lower analgesic use. Joshi active drug.
et al.20 reported the clinical use of the USSQ
for evaluation of quality of life after ureteral Acknowledgement
stent placement. Among 62 patients who The authors wish to thank Shirani
completed the questionnaire, up to 80% Kanaganayagam for her assistance in
experienced stent-related problems that preparing the manuscript.
affected their work performance, general
health and quality of life, with the most Conflicts of interest
bothersome symptoms being storage The authors had no conflicts of interest to
problems and incontinence. 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
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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
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