Ahmed AF et al, 2016: Role of Tamsulosin Therapy after Extracorporeal Shockwave Lithotripsy for Renal Stones: Randomized Controlled Trial.
Ahmed AF, Shalaby E, El-Feky M, Kotb A, Elsotohi E, El-Kholy M Jr, Ragab A, Salem E.
Department of Urology, Al-Azhar University, Cairo, Egypt.
Abstract
INTRODUCTION: To evaluate the efficacy of adjunctive tamsulosin therapy after extracorporeal shockwave lithotripsy (SWL) for renal stones.
MATERIALS AND METHODS: This prospective study was conducted on patients who underwent single-session SWL for solitary renal stone less than 20 mm. Post-SWL, patients were randomly divided into 2 groups; the tamsulosin group (TG), received a daily dose of tamsulosin 0.4 mg, for a maximum of 12 weeks, with post-SWL traditional analgesia and control group (CG), received the traditional analgesia alone. RESULTS: The study enrolled 271 patients and eventually only 249 (123 in TG and 126 in CG) completed the study. The overall stone free rate was 73.5%: 78.0% in TG and 69.0% in CG (p = 0.108). In TG, 8.1% of patients experienced at least one episode of acute renal/ureteral colic compared with 19.8% of controls (p = 0.008). The mean cumulative analgesia dosage per subject was 313 mg in TG and 346 mg in CG (p < 0.001). Overall, 14 patients developed steinstrasse and 6 of them (all in CG) needed urgent intervention (p = 0.031). CONCLUSIONS: Daily tamsulosin therapy does not enhance the clearance of stone fragments but decreases the painepisodes, analgesia dosage and need for adjuvant intervention after SWL for renal stones.
Urol Int. 2016 Apr 16. [Epub ahead of print]
Comments 1
“Post-SWL, eligible patients were randomly assigned into one of 2 groups using the coin toss method.” A selection bias cannot be excluded: why took it 3 years and 4 different urological departments to recruit 270 patients? The frequency of acute colic episodes and re-hospitalization, and the cumulative analgesia usage were significantly different.
We know from the Pickard et al. study (Pickard R et al. Medical expulsive therapy in adults with ureteric colic: a multicentre, randomised, placebo-controlled trial.
Lancet. 2015 Jul 25;386(9991):341-9) that α-blockers might not be as effect as was always documented. The present study suffers from the fact that it was not placebo-controlled. Patient who had to take a tablet every day to improve the post-ESWL conditions probably also drank more water and we know that increased fluid uptake improves ESWL results. With the controversies on α-blockers I would only trust studies which control and record the urine output.
See also: De Nunzio C, Brassetti A, Bellangino M, Trucchi A, Petta S, Presicce F, Tubaro A. Tamsulosin or Silodosin Adjuvant Treatment Is Ineffective in Improving Shockwave Lithotripsy Outcome: A Short-Term Follow-Up Randomized, Placebo-Controlled Study. J Endourol. 2016 May 11.