Tamsulosin as adjuvant treatment for increasing calculus

ORIGINAL ARTICLE
Tamsulosin as adjuvant treatment for
increasing calculus-free state after
extracorporeal shock wave lithotripsy
(ESWL) in nephro- and pyelolithiasis
Aguilar-Moreno JA,1 Maldonado-Ávila A,2 Garduño-Arteaga L,2 Castell-Cancino R,2 Jaspeasen-Gastélum J,2
Virgen-Gutiérrez F.1
•ABSTRACT
•RESUMEN
Background: Through the utilization of both
extracorporeal shock wave lithotripsy (ESWL) and
medical expulsive therapy a calculus-free state can be
achieved in a single procedure and at low cost to the
patient. In this context, medical expulsive therapy plays
an important adjuvant role following ESWL.
Introducción: Si se asocia la LEOCH con la terapia médica expulsiva se puede lograr un estado libre de cálculos
con un solo procedimiento y con bajos costos para el paciente. En este contexto, el tratamiento médico expulsivo
puede jugar un papel adyuvante importante después de
una LEOCH.
Materials and methods: From September to
December 2008 a total of 30 patients programmed for
ESWL with a single, radiopaque kidney or renal pelvic
stone not larger than 20 mm in diameter, with or
without double-J catheter, were included in the study.
They were re-evaluated as out-patients 2 and 3 months
after lithotripsy by means of simple abdominal X-ray,
analyzing calculus-free state as the total absence of
stones at the kidney and renal pelvic level. There were
successful results in 7 of the 15 patients (46.6%) of
the tamsulosin group and in 5 of the 15 patients (33.3%)
in the group receiving standard treatment. Analysis with
Student t test and Levene’s test was not statistically
significant (P=0.473). It was therefore concluded that
tamsulosin, as adjuvant treatment following ESWL,
offers no additional benefit.
Material y métodos: De septiembre a diciembre de
2008, se incluyó un total de 30 pacientes programados
para LEOCH con cálculo renal o piélico, único, radiopaco, de 20 mm de diámetro como máximo, con catéter
ureteral doble J o sin él. Fueron revalorados en la consulta externa con placa simple de abdomen al mes, a los
2 y 3 meses de haber sido sometidos a la litotricia y se
analizó el estado libre de cálculos como la ausencia total de cálculos a nivel renal y piélico. El éxito dentro del
estudio se obtuvo en siete de 15 pacientes (46.6%) del grupo con tamsulosina y en cinco de 15 pacientes (33.3%) del
grupo que sólo recibió tratamiento estándar. El análisis con
prueba t de Student y prueba de Levene no alcanzó significancia estadística (p= 0.473), por lo que se concluye que
la tamsulosina, como tratamiento adyuvante posterior a
LEOCH en cálculos renales y piélicos, no ofrece un beneficio adicional.
Key words: tamsulosin, extracorporeal shock wave
lithotripsy.
Palabras clave: tamsulosina, litiasis, litotricia extracorpórea por ondas de choque.
1Urology Service Resident, Hospital General de México O.D.,
Mexico City. 2Urology Service Staff Physician, Hospital General
de México O.D., Mexico City.
Corresponding author: Dr. José A. Aguilar Moreno. Dr. Balmis Núm.
148, Col. Doctores, Deleg. Cuauhtémoc, C.P. 06726. México, D. F.
Email: [email protected]
Rev Mex Urol 2010;70(1):11-14
11
Aguilar-Moreno JA, et al. Tamsulosin as adjuvant treatment for increasing calculus-free state after extracorporeal
shock wave lithotripsy (ESWL) in nephro- and pyelolithiasis
•INTRODUCTION
•MATERIALS AND METHODS
Worldwide urinary lithiasis prevalence varies from
4-17 cases per 1000 inhabitants.1 In Mexico very few
epidemiological studies have been carried out on the
pathology. Otero et al. reported that this urinary lithiasis
makes up 13% of all hospitalizations for kidney disease
in the public health system’s Instituto Mexicano del
Seguro Social (IMSS).2
A randomly assigned clinical trial was carried out at the
urology service of the Hospital General de México in
the department of Extracorporeal Shock Wave
lithotripsy.
Studies carried out on large series of calculi
cases agree that 70-80% of stones are spontaneously
eliminated with or without symptomatic treatment and
the remaining cases require urological treatment. In the
majority of cases extracorporeal shock wave lithotripsy
(ESWL) is the first treatment of choice. However, it is
not always easy to attain a fine fragmentation of the
calculi even after various sessions.3 Calculus location
and size, expressed in millimeters from its two major
axes, continue to be important factors for deciding
which therapeutic technology to utilize. Eighty percent
of urinary tract calculi are treated with ESWL.4
The urology service of the authors’ hospital has a
fourth generation Dyrex Duet lithotriptor with two
hydroelectric energy source bulbs (bifocal). One of the
qualities of this type of machine is the synchronous or
asynchronous energy firing mode, in other words, firing
from two distinct focal points (F2 and F2´).5
A more adequate cavitation has been observed
when the stone is fragmented from two distinct focal
points and there is less injury to renal tissue due to the
fact that the shock waves reach the focal region with a
temporal as well as a spacial phasing out.6
Micali et al. evaluated the use of nifedipine
or tamsulosin, both of which are associated with
ketoprofen in patients with ureteral stones treated
with ESWL. They reported better calculi-free states
with nifedipine and tamsulosin than with lithotripsy
alone (85.7 and 82.1% vs 51.7 and 57.1%) and came
to the conclusion that ESWL efficacy can be increased
using associated expulsive medical therapy, increasing
the calculi-free state and reducing the necessity to
re-treat patients.7
Today there are a limited number of studies
comparing the use of tamsulosin as an adjuvant for
extracorporeal lithotripsy with its expulsive therapeutic
use in ureteral lithiasis. The purpose of the present
study is to determine if there is an association between
tamsulosin use and calculi-free state after extracorporeal
lithotripsy in nephro- and pyelolithiasis.
The principle objective is to determine the efficacy
of tamsulosin as adjuvant treatment for increasing
calculi-free state after an ESWL session for nephro- and
pyelolithiasis.
12
Rev Mex Urol 2010;70(1):11-14
A complete medical history was retrieved from all
patients and routine presurgical laboratory tests were
carried out that included complete blood count, blood
chemistry, coagulation times, urinalysis and urine
culture. All cases were evaluated by means of simple
abdominal X-ray. The first stone measurement was
taken from these X-rays so that patients could be
included in the study.
All patients underwent a single ESWL session with
a fourth generation bifocal Dyrex Duet lithotriptor
with a hydroelectric energy source and a fluoroscopic
localization system.
After the lithotripsy sessions patients were
randomly assigned by a number table to receive the
standard treatment of the authors’ service which was
ciprofloxacin tablets 1 g VO c/24 hrs x 7 days and
ketorolac tablets 10 mg c/8 hrs as necessary (group
A) or tamsulosin tablets 0.4 mg daily for 1 month
plus the same antibiotic and analgesic just described
(group B). At the time of hospital release patients
were instructed to drink at least 1.5-2 liters of water
per day.
Patients were re-evaluated in the out-patient
service with simple abdominal X-ray at 1, 2 and 3
months after having undergone lithotripsy. Calculi
free-state was analyzed as established in the variable
definition Table.
Statistical analysis was done using Windows SPSS
(Statistical Package for the Social Sciences version 16.0)
and study variable contingency tables, Student t test
and Levene’s test were used.
•RESULTS
A total of 30 patients, 14 men and 16 women were
included in the study. Mean age was 42.97 years with a
range from 24-73 years (Image 1).
Mean number of shock waves applied during ESWL
was 3666 waves for both groups and mean wave
intensity applied was 8.83 Kv.
The side of the body and localization of stones
studied was as follows: left side with 15 stones (50%)
and right side with 15 stones (50%). The most frequent
stone localization was the renal pelvis in 16 cases, 5
in the superior calyx, 5 in the middle calyx and 4 in the
inferior calyx (Image 2).
Aguilar-Moreno JA, et al. Tamsulosin as adjuvant treatment for increasing calculus-free state after extracorporeal
shock wave lithotripsy (ESWL) in nephro- and pyelolithiasis
9
Number of calculi
10
14 (46.7%)
16 (53.3%)
8
7
6
4
3
4
1
1
2
0
3
2
Renal pelvis
(53.3%)
Superior Calyx
(16.6%)
Middle Calyx
(16.6%)
Inferior Calyx
(13.3%)
Localization
Men
Women
Right Side (50%)
Image 1. Distribution by sex
Image 2. Calculi side and localization distribution
10
14
8.27
8
Tamsulosin +
Standard TX
6.87
8.07
5.33
4
5.73
Standard TX
3.53
2
1er Month
2do Month
4
2
Standard
Image 3. Differences in calculi size reduction between both groups (mm)
Tamsulosin
Treatment
3er Month
Time
7
5
6
0
0
Initial
8
8
11.27
Patients
mm
10
11.8
12
10
Left Side (50%)
With stone
Without stone
Image 4. Calculi-free state at the end of the study
•CONCLUSIONS
Initial stone size varied from 4-20 mm with a mean
11.53 mm. One month after ESWL the mean went down
to 8.07 mm in the tamsulosin group and to 8.27 mm
in the standard treatment group. At the second month
measurements were 5.33 mm for the tamsulosin group
and 6.87 mm for the standard group. Finally, at the third
month the mean was 3.53 mm in the tamsulosin group
and 5.73 mm in the standard group (Image 3).
Tamsulosin has been successfully used in distal ureteral
stone management and constitutes first line treatment
in numerous Mexican hospital centers.8 In relation to
its use as adjuvant treatment in kidney calculi after
Extracorporeal Shock Wave Lithotripsy the present study
did not show it to be useful since there was no statistical
significance between groups.
There was study success, defined as calculi-free
state, in 7 of the 15 patients (46.6%) of the tamsulosin
group and in 5 of the 15 patients (33.3%) in the standard
treatment group. Student t test and the Levene’s test
revealed no statistical significance between groups
(0.473 vs 0.05) (Image 4).
This study represents an advance in the study of
different uses of tamsulosin in the field of urology
and the authors feel this type of research should be
continued with further studies on different populations
and with larger samples in order to establish the true
usefulness of this treatment.
Rev Mex Urol 2010;70(1):11-14
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Aguilar-Moreno JA, et al. Tamsulosin as adjuvant treatment for increasing calculus-free state after extracorporeal
shock wave lithotripsy (ESWL) in nephro- and pyelolithiasis
BIBLIOGRAPHY
1.
2.
3.
4.
14
Medina EM, Mussaret Z, Real de León E, Orozco RS. Prevalencia y
factores de riesgo en Yucatán, México, para litiasis urinaria. Salud
Publica Mex 2002;44:541-5.
Otero F, Lugo A, Durán A. Las enfermedades renales en el Instituto
Mexicano del Seguro Social (1982-1989). Rev Asoc Med Int Mex
11;1995:21-9.
Daudon M. Epidemiology of nephrolithiasis in France. AnnUrol
2005;39(6):209-31.
Traxer O. Tratamiento quirúrgico de la litiasis urinaria. Encycl Med
Chir (Editions Scientifiques et Medicales Elsevier, SAS, París), Nephrologie-Urologie, 18-106-A-10, 2003, 24
Rev Mex Urol 2010;70(1):11-14
5.
6.
7.
8.
Castell R, Garduño L, Cruz NE. Estudio descriptivo de litotricia extracorpórea con litotriptor Dyrex Duet (bifocal) en pacientes del Hospital
General de México. Rev Mex Urol 2005;65(4):226-32.
Loske AM, Gutiérrez J. Evaluación in vivo de un sistema de enfoque
alterno para litotripsia extracorporal electrohidráulica. Rev Mex Urol
2004;64(6):265-71.
Micali S, Grande M, Sighinol MC. Efficacy of expulsive therapy using
nifedipine or tamsulosina, both associated with ketoprofene, after
shock wave lithotripsy of ureteral stones. Urol Res 2007;35(3):133–7.
Maldonado AM, Castellanos LJ, Enriquez LJ. Estudio comparativo de
la eficacia de la tamsulosina vs. nifedipina para la expulsión de litos
ureterales de tercio inferior. Rev Mex Urol 2006;66(2):83-7.