Indian Journal of Urology Users online:257  
IJU
Home Current Issue Ahead of print Editorial Board Archives Symposia Guidelines Subscriptions Login 
Print this page  Email this page Small font sizeDefault font sizeIncrease font size


 
UROSCAN
Year : 2010  |  Volume : 26  |  Issue : 1  |  Page : 148-149
 

Tamsulosin for distal ureteric calculus: Does it deliver the goods?


Department of Urology, Christian Medical College, Vellore, India

Date of Web Publication23-Mar-2010

Correspondence Address:
T J Nirmal
Department of Urology, Christian Medical College, Vellore
India
Login to access the Email id

Source of Support: None, Conflict of Interest: None


Rights and PermissionsRights and Permissions

 

How to cite this article:
Nirmal T J, Kekre NS. Tamsulosin for distal ureteric calculus: Does it deliver the goods?. Indian J Urol 2010;26:148-9

How to cite this URL:
Nirmal T J, Kekre NS. Tamsulosin for distal ureteric calculus: Does it deliver the goods?. Indian J Urol [serial online] 2010 [cited 2019 Nov 18];26:148-9. Available from: http://www.indianjurol.com/text.asp?2010/26/1/148/60467

Thomas Hermanns, Peter Sauermann, Kaspar Rufibach, Thomas Frauenfelder, Tullio Sulser, Rato T. Strebel. Is there a role for tamsulosin in the treatment of distal ureteral stones of 7 mm or less? Results of a randomised, double-blind, placebo-controlled trial. European Urology 2009;56:407-12.



   Summary Top


This randomized, double-blind, placebo- controlled trial evaluated the efficacy of medical expulsive therapy (MET) with tamsulosin. [1] Patients $18 years of age, presenting with acute renal colic, were eligible if they had a single ureteric calculus measuring 7 mm or less below the level of the common iliac vessels on a non contrast enhanced computed tomography (CT). Presence of multiple stones, renal insufficiency, urinary tract infection, solitary kidney, pregnancy, history of previous ureteral intervention, hypersensitivity to tamsulosin; and current á-blocker, calcium-antagonist or corticosteroid medication formed the criteria for exclusion. Patients were randomized in a 1:1 fashion to receive either a single dose of tamsulosin 0.4 mg or placebo once daily for 21 days. A sample size of 43 in each group was calculated taking a power of 80% to detect a clinically relevant difference in expulsion rate of 25% between the two groups. A weekly follow-up with urinalysis, serum creatinine estimation, ultrasonography/abdominal X-ray was done. Medication was discontinued after either spontaneous stone expulsion or intervention. Primary end point was stone expulsion rate as confirmed by low dose CT done at the end of the study. Secondary end points included the time to stone passage, total amount of analgesic used, maximum daily pain score, side effects related to therapy and the intervention rate. Of the 100 enrolled, 45 were evaluable in each group. Baseline characteristics of age, gender, stone size and location were similar for both groups. The median stone size for the entire population was 3.9 mm. Spontaneous stone expulsion rate was not significantly different between the tamsulosin arm (86.7%) and the placebo arm (88.9%; P = 1.0). Expulsion rate was not significantly different between the treatment arms for patients with stones ≤5 mm (P = 1.00) or for those with larger stones (P = 1.00). Median time to stone passage was seven days (95% CI: 3-10) in the tamsulosin arm, and 10 days (95% CI: 3-20) in the placebo arm (P = 0.36). Patients in the tamsulosin arm had lower analgesic requirements until stone expulsion (P = 0.012). The authors conclude stating that MET with tamsulosin, for ureteric calculi of ≤7 mm, was not beneficial in terms of improved expulsion rates but it could reduce the need for analgesics until expulsion.


   Comments Top


The administration of drugs to facilitate spontaneous stone passage, also known as "Medical Expulsive Therapy" or MET was endorsed by the joint EAU/AUA nephrolithiasis guideline panel as one of the treatment options for a newly diagnosed ureteral calculus of <10 mm amenable to conservative management. [2] MET not only seemed to facilitate stone passage by as much as 65% but also claimed to reduce the time to expulsion and analgesic requirements.[3] The beneficial effects of these drugs are attributed to ureteral smooth muscle relaxation mediated through either inhibition of calcium channel pumps or á-1 receptor blockade. [4] Studies also show that á-blockers are superior to nifedipine in achieving these effects. [ 3] However, critical analysis of these studies, including meta-analyses revealed several methodological flaws and the need to conduct a well designed study was felt. This lacuna has somewhat been filled by the study by Hermanns et al. It also happens to be the first randomized, double-blind, placebo-controlled trial evaluating the efficacy of tamsulosin vs. placebo as MET. Apart from the study design per se, the use of CT for the diagnosis, measurement and follow up of calculi lends credibility to the study. Contrary to expectations, this trial failed to show improved expulsion rates with tamsulosin, adding to the evidence from another similar study conducted with alfuzosin. [5] It is well known that spontaneous expulsion rates of distal ureteric calculi ≤5 mm are as high as 71-98%. [3] Approximately 80% of the study population fell in this subgroup and would have passed out the stone with or without medication; exposing a major limitation of this study. Even in patients with larger stones, tamsulosin did not make a difference. However, the sample size was too small to support this analysis. Time of expulsion, though not statistically significant, was three days shorter in the tamsulosin group; the fact that 32% of the patients failed to record the exact time of stone passage casts doubts on the importance of this observation. A significantly lower analgesic requirement in those taking tamsulosin may be attributed to shorter time to expulsion and needs to be validated in the setting of an acute episode to prove any kind of direct analgesic effect. Contrary to the results of this trial, a more recent study using á-1D specific antagonist naftopidil claims to significantly improve expulsion rates. [6] Moreover, encouraging results have also been reported when a second cycle of tamsulosin was used in non-responders. [7] The safety profile, non-invasive nature and potential cost savings from MET are too attractive a proposition to ignore. Further, large, multicenter trials are required to identify the patient population most likely to benefit from MET.

 
   References Top

1.Hermanns T, Sauermann P, Rufibach K, Frauenfelder T, Sulser T, Strebel RT. Is there a role for tamsulosin in the treatment of distal ureteral stones of 7 mm or less? Results of a randomised, double-blind, placebo-controlled trial. Eur Urol 2009;56:407-12.  Back to cited text no. 1      
2.Tiselius HG, Alken P, Buck C, Gallucci M, Knoll T, Sarica K, Turk C. Guidelines on urolithiasis. Arnhem, The Netherlands: European Association of Urology (EAU); 2008. p. 128.  Back to cited text no. 2      
3.Hollingsworth JM, Rogers MA, Kaufman SR, Bradford TJ, Saint S, Wei JT et al. Medical therapy to facilitate urinary stone passage: A meta-analysis. Lancet 2006;368:1171.  Back to cited text no. 3      
4.Malin JM, Deane RF, Boyarsky S. Characterisation of adrenergic receptors in human ureter. Br J Urol 1970;42:171-4.  Back to cited text no. 4      
5.Pedro RN, Hinck B, Hendlin K, Feia K, Canales BK, Monga M. Alfuzosin stone expulsion therapy for distal ureteral calculi: A double-blind, placebo controlled study. J Urol 2008;179:22447.  Back to cited text no. 5      
6.Sun X, He L, Ge W, Lv J. Efficacy of selective alpha1D-blocker naftopidil as medical expulsive therapy for distal ureteral stones. J Urol 2009;181:1716-20.  Back to cited text no. 6      
7.Porpiglia F, Fiori C, Ghignone G, Vaccino D, Billia M, Morra I, Ragni F, Scarpa RM. A second cycle of tamsulosin in patients with distal ureteric stones: A prospective randomized trial. BJU Int 2009;103:1700-3.  Back to cited text no. 7      




 

Top
Print this article  Email this article
Previous article Next article

    

 
   Search
 
   Next article
   Previous article 
   Table of Contents
  
    Similar in PUBMED
   Search Pubmed for
   Search in Google Scholar for
    Article in PDF (601 KB)
    Citation Manager
    Access Statistics
    Reader Comments
    Email Alert *
    Add to My List *
* Registration required (free)  


    Summary
    Comments
    References

 Article Access Statistics
    Viewed2863    
    Printed153    
    Emailed1    
    PDF Downloaded159    
    Comments [Add]    

Recommend this journal

HEALTHWARE INDIA