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Three Part Question

In [adult patients with ureteral stones <10mm] does [tamsulosin] improve [clearance rate] and reduce [stone expulsion time]

Clinical Scenario

An adult patient presents to the emergency department with acute renal colic ('loin-to-groin' pain). You would like to give Tamsulosin 'off-label' to facilitate stone passage.

Search Strategy

Medline 1966 - 06/2014 using the Ovid database

Cochrane Database of Systematic Reviews

Medline 1966 - 06/2014 using the Ovid database

1. exp Ureterolithiasis/; 2. Ureteral Obstruction/; 3. Colic/; 4. ureterolithiasis.tw.; 5. ureter$ adj3 (stone$ or calcul$ or colic)).tw.; 6. or/1-5; 7. exp Adrenergic alpha-Antagonists/; 8. alpha blocker$.tw.; 9. alpha receptor antagonist$.tw.; 10. exp Prazosin/; 11. tamsulosin.tw.; 12. doxazosin$.tw.; 13. alfuzosin.tw.; 14. terazosin.tw.; 15. silodosin.tw.; 16. or/7-15; 17. and/6,16; 18. limit 17 to (abstracts and English language and humans); 19. limit 18 to ("all adult (19 plus years)" and randomised controlled trial)

Cochrane Database of Systematic Reviews

Tamsulosin OR alpha blocker OR medical expulsive therapy AND ureteral calculus

Search Outcome

Medline 1966 - 06/2014 using the Ovid database

60 studies found; 8 relevant for this review

Cochrane Database of Systematic Reviews

15 studies found; 2 relevant for this review

Relevant Paper(s)

Author, date and country	Patient group	Study type (level of evidence)	Outcomes	Key results	Study Weaknesses
Cervenakov et al. 2002 Slovakia	Location: Inpatients Participants: 104 patients aged 17 – 76 yrs with lower urinary tract stones <10mm confirmed by X-ray Group T (treatment): 51 patients, aged 17 – 74 yrs, M/F 33/18 Group C (control): 53 patients, aged 18 – 76 yrs, M/F 32/19 Exclusions: Pregnant women, patients with diabetes mellitus, febrile, advanced hydronephrosis, UTI, grave polyvalent allergies	Randomised controlled trial Double-blind Study duration: 06/1999 – 01/2002 Follow-up/treatment duration: 7 days Group T vs. Group C Group T: Standard therapy + Tamsulosin 0.4mg Standard therapy: Tramadol 50mg + Diazepam 5mg + anti-emetic + NSAID + 2.5L water Group C: Standard therapy	Stone clearance rate	80.4% (T) vs. 62.8% (C) p <0.05	None
Hermanns et al. 2009 Switzerland	Location: Outpatients Participants: 90 patients aged >18 yrs with single ureteral stone <7mm below the common iliac vessels confirmed by CT Group T: 45 patients (M/F 39/6), median age 36 yrs (range 30 – 44 yrs) Group C:: 45 patients (M/F 36/9), median age 41 yrs (range 33 – 54) Exclusion: Multiple ureteral stones, renal failure (eGFR <60), UTI, single kidney, or pregnancy	Randomised controlled trial Double-blind, placebo-controlled Study duration: 09/2006 – 09/2008 Follow-up/treatment duration: 21 days Group T: Tamsulosin 0.4mg/d Group C: Placebo	Stone clearance rate	86.7% (T) vs. 88.9% (C) p = 1.0	Small stone size
			Stone expulsion time	7 ± 4.5d (T) vs. 10 ± 8.5d (C) p = 0.36
Ferre et al. 2009 USA	Location: ED Participants: 80 patients aged >18 yrs with single distal ureteral stone confirmed by CT Group T: 39 patients Group C: 41 patients Exclusion: Tamsulosin allergy, sulfa-/sulfonamide allergy, lithiasis of the ureteral intramural tract, AKI or CKD, fever, multiple stones, peptic ulcer disease, liver failure, pregnancy, breastfeeding, history of urinary surgery, history of endoscopic treatment, treatment with –lytic drugs, calcium channel blockers, nitrates, and vardenafil hydrochloride, inability to use pain scale, inability to read, write, and speak English	Randomised controlled trial Double-blind Study duration: 08/2006 – 09/2007 Follow-up/ treatment duration: 14 days Group T: Tamsulosin 0.4mg/d for 10 days Group C: Standard therapy Standard therapy: Ibuprofen 300mg tds, Oxycodone 5 – 10mg PO, tds/qds	Stone clearance rate (at 14 days)	77.1% (T) vs. 64.9% (C) p = 0.504	No placebo
Al-Ansari et al. 2010 Qatar	Location: Single centre Participants: 100 patients with ureteral stones <10mm confirmed by X-ray, US, and CT Group T: 50 patients (M/F 32/18), mean age 37.18 yrs (± 9.38) Group C: 50 patients (M/F 29/21), mean age 36.13 yrs (± 9.32) Exclusion: age <18 yrs, non-radiopaque stones, multiple stones, severe hydronephrosis , pregnancy, hypotension, peptic ulcer, previous endoscopic or open ureteral surgery, use of calcium channel blocker	Randomised controlled trial Double-blind, placebo-controlled Study duration: 05/2007 – 05/2009 Follow-up: 4 weeks Group T: Tamsulosin 0.4mg/d Group C: Placebo	Stone clearance rate	82% (T) vs. 61% (C) p = 0.02	None
			Stone expulsion time	6.4d ± 2.8d (T) vs. 9.9d ± 5.4d (C) p = 0.001
Ye et al. 2010 China	Location: Multicentre (10) Participants: 3189 patients aged 18 – 50 yrs with a single distal ureteral stone 4 – 7mm confirmed by X-ray, US, CT, or IVU Group T1: 1596 patients (M/F 998/598), median age 30.7 yrs (range 18 – 48 yrs) Group T2: 1593 patients (M/F 989/604), median age 34.5 yrs (range 22 – 50 yrs) Exclusion: fever, UTI, severe hydronephrosis , renal failure, multiple stones, urethrostenosis, ureteric stricture, peptic ulcer, diabetes, hypotension, pregnancy, current use of alpha blockers, CCBs or corticosteroids, allergy to any of the study medications	Randomised controlled trial Study duration: NS Follow-up/treatment duration: 4 weeks Group T1: Standard treatment + Tamsulosin 0.4mg/d Group T2: Standard treatment + Nifedipine 10mg tds Standard treatment: Water 2 – 2.5L, Levofloxacin 0.2 g bd, diclofenac 50mg suppository as required	Stone clearance rate	95.86% (T1) vs. 73.51% (T2) p <0.01	None
			Stone expulsion time	3.3 ± 2.5d (T1) vs. 5.7 ± 2.7d (T2) p <0.01
Vincendeau et al. 2010 France	Location: Multicentre Participants: 129 patients >18 yrs with a distal ureteral stone 2 – 7mm Group T: 66 patients (M/F 46/20), mean age 38.9 yrs (± 13.4) Group C: 63 patients (M/F 53/10), mean age 39.0 yrs (± 11.4) Exclusion: pregnant, breastfeeding, current alpha/beta blocker therapy, hypotension, liver failure, surgical requirement, spontaneous passage	Randomised controlled trial Placebo-controlled Study duration: 02/2002 – 12/2006 Follow-up/treatment duration: 6 weeks Group T: Standard treatment + Tamsulosin 0.4mg/d (for 42 days or until stone expulsion) Group C: Standard treatment + Placebo Standard treatment: ibuprofen 50mg tds, phloroglucinol 80mg x 6/d + 2L water/d	Stone clearance rate	77.0% (T) vs. 70.5% (C) p = 0.41	No blinding
			Stone expulsion time	9.6 ± 9.8d (T) vs. 10.1 ± 10d (C) p = 0.82
Singh et al. 2010 India	Location: Outpatients Participants: 60 patients aged 18 – 70 yrs with a single upper ureteral calculi 6 – 10mm confirmed by X-ray and ultrasound Group T: 30 patients (M/F 44/15), mean age 32.2 yrs (± 12.22) Group C: 30 patients (M/F 41/17), mean age 36 yrs (± 13.78) Exclusion: UTI, fever, AKI, previous endoscopic or open urinary tract surgery, distal obstruction, severe hydronephrosis , pregnancy, treatment with alpha blockers, CCBs, or steroids, morbid obesity (BMI >30), history of failed ESWL	Randomised controlled trial Double-blind Study duration: 01/2006 – 06/2008 Follow-up/treatment duration: 3 months Group T: ESWL + Tamsulosin 0.4mg/d Group C: ESWL	Stone clearance rate	93% vs. 90% p = 0.68	No placebo

Comment(s)

Tamsulosin use in adult patients with ureteral stones <10mm improves stone clearance rate and shortens stone expulsion time. Tamsulosin may reduce the duration of acute renal colic and the rate of complications (hydronephrosis, UTI, impaired renal function). Medical expulsive therapy with Tamsulosin could reduce more invasive interventions such as ESWL along with its complications and use of hospital resources. In adult patients presenting with acute renal colic and a ureteral stone <10mm confirmed by imaging should be offered medical expulsive therapy with Tamsulosin as part of initial management protocol.

Editor Comment

KMJ

Clinical Bottom Line

Tamsulosin significantly improves stone clearance rate and stone expulsion time for ureteral stones <10mm.

References

1. Cervenakov I, Fillo J, Mardiak J, Kopecny M, Smirala J, Lepies P Speedy elimination of ureterolithiasis in lower part of ureters with the alpha 1-blocker--Tamsulosin International Urology & Nephrology 2002;34(1):25-9
2. 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 European Urology 2009;56(3):407-12
3. Ferre RM, Wasielewski JN, Strout TD, Perron AD Tamsulosin for Ureteral Stones in the Emergency Department: A Randomized, Controlled Trial Annals of Emergency Medicine 2009;54(3):432-9
4. Al-Ansari A, Al-Naimi A, Alobaidy A, Assadiq K, Azmi MD, Shokeir AA Efficacy of Tamsulosin in the Management of Lower Ureteral Stones: A Randomized Double-blind Placebo-controlled Study of 100 Patients Urology 2010;75(1):4-7
5. Ye ZQ, Yang H, Li H, Zhang XC, Deng YL, Zeng GH, et al. A multicentre, prospective, randomized trial: comparative efficacy of tamsulosin and nifedipine in medical expulsive therapy for distal ureteric stones with renal colic Bju International 2011;108(2):276-9
6. Vincendeau S, Bellissant E, Houlgatte A, Dore B, Bruyere F, Renault A, et al. Tamsulosin Hydrochloride vs Placebo for Management of Distal Ureteral Stones A Multicentric, Randomized, Double-blind Trial Archives of Internal Medicine 2010;170(22):2021-7
7. Singh SK, Pawar DS, Griwan MS, Indora JM, Sharma S Role of Tamsulosin in Clearance of Upper Ureteral Calculi After Extracorporeal Shock Wave Lithotripsy A Randomized Controlled Trial Urology Journal 2011;8(1):14-20