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. 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