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\title{Role of Short Term Tamsulosin in Medical Management of Lower Ureteric Calculi in Today's Modern Era of Increasing Demand of Various Advancing Endo-Urological Procedures}
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             \author[1]{Aditya Avinash  Yelikar}

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\date{\small \em Received: 7 December 2019 Accepted: 3 January 2020 Published: 15 January 2020}

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\begin{abstract}
        


Introduction: The choice of ideal method like MET or URS to treat lower ureteric calculi depends on the type of equipment available, type and size of stone, needs of the patient and skills of the surgeon. The smooth muscle relaxant drug tamsulosin (an ?-adrenoceptor antagonist) is a possible agent, its use being termed medical expulsive therapy (MET). The disease spectrum in a developing country like ours is different from that of developed countries, mainly because of delay in diagnosis, delay in investigations and lack of awareness that tend to modify outcome in case of ureteral stones or for that matter any disease. More so, advanced interventional facilities in this part of the world are not easily available. Methodology: A prospective study was thus planned to compare the tamsulosin group with a control group in our setup to evaluate the efficacy of tamsulosin for lower ureteric calculi expulsion within a few days without the need for hospitalisation, common endoscopic treatment or shock wave lithotripsy.

\end{abstract}


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\let\tabcellsep& 	 	 		 \par
Role of Short Term Tamsulosin in Medical Management of Lower Ureteric Calculi in Today's Modern Era of Increasing Demand of Various Advancing Endo-Urological Procedures Introduction use being termed medical expulsive therapy (MET) \hyperref[b3]{[4]}. Meta-analyses of data from randomised controlled trials (RCTs) report a statistically significant benefit fortamsulosin over controls for the outcome of spontaneous stone passage \hyperref[b4]{[5,}\hyperref[b5]{6]}.\par
Where a failed expectant treatment may well be complicated with hydro-nephrosis, deranged renal function or urosepsis. Interventional techniques are not always free of complications and failures.Most of the work of the efficacy of tamsulosin in lower ureteric calculi expulsion has been done in western affluent countries with variable results. The disease spectrum in a developing country like ours is different from that of developed countries, mainly because of delay in diagnosis, delay in investigations and lack of awareness that tend to modify outcome in case of ureteral stones or for that matter any disease. More so, advanced interventional facilities in this part of the world are not easily available. A prospective study was thus planned to compare the tamsulosin group with a control group in our setup to evaluate the efficacy of tamsulosin for lower ureteric calculi expulsion within a few days without the need for hospitalisation, common endoscopic treatment or shock wave lithotripsy. 
\section[{II.}]{II.} 
\section[{Methodology}]{Methodology}\par
After taking clearance/permission from the ethical committee of our hospital we did a Prospective randomised control study from feb 2014 to feb 2017 including 600 subjects in age group of 20-50 years with unilateral ureteric calculi of size 4mm-10mm. Patients having acute renal failure, chronic renal failure , urinary tract infection, fever \& who have recently undergone surgery for ureteric calculi were not included in the study. The study group was given cap Tamsulosin 0.4mg\& tablet Dytor 10mg once daily for a maximum of 2 weeks or till the stone was passed (whichever was earlier). Analgesic (table tdiclofenac 100mg) was given as needed. The control group was given analgesic and diuretic tablets only for same period. During the study time a ultra sonography (KUB)was done on day 0 of starting tamsulosin treatment followed by on day 7, day 14 and day 17. Results were compared between the Author: e-mail: aditya.yelikar@gmail.com he choice of ideal method like MET or URS to treat lower ureteric calculi depends on the type of equipment available, type and size of stone, needs of the patient and skills of the surgeon \hyperref[b0]{[1]}. The stone burden remains the primary factor in deciding the appropriate treatment for a patient with ureteric calculi \hyperref[b1]{[2]}.\par
Expectantly managed patients who develop recurrent pain, sepsis, or compromised renal function need drainage if necessary followed by stone clearance using endoscopy or extracorporeal shock wave lithotripsy \hyperref[b2]{[3]}.\par
The smooth muscle relaxant drug tamsulosin (an ?-adrenoceptor antagonist) is a possible agent, its T 
\section[{III. Results \& Observations}]{III. Results \& Observations} 
\section[{Consort Flow Diagram}]{Consort Flow Diagram}\par
All patients in our study were between the age group of 20-50 years. In our study the incidence of ureteric calculi was found to be more in males (81.44\%) as compared to females (18.54\%) .We found incidentally that more stones were on the right side (51.61\%) as compared to the left side (48.38\%) .No patient in group 1 had pain score in the range of 8-10 whereas 3.22\% of patients in group 2 had a pain score in the range of 8 -10. 83.87\% of stones in group 1 \& 62.90\% stones in group 2 passed out successfully. 17.74 \% of patients in group 1 \& 37.09\% of patients in group 2 needed surgical intervention .However the need for surgical intervention for stone size up to 6mm was same in both the groups.   
\section[{IV . Discussion}]{IV . Discussion}\par
Treatment modalities for ureteral stones have greatly changed during the last 20 years, especially following the introduction of minimally invasive procedures such as extra-corporeal shock wave lithotripsy and uretero-renoscopy. The advantage of the medical expulsive therapy is important, because the risks which are related to a surgical intervention are not trivial \hyperref[b6]{[7]}. Studies have reported the overall complication rates after ureteroscopic lithotripsies to be 10-20\%, with major complications such as ureteral perforations, avulsions and strictures occurring during 3-5\% of the procedures \hyperref[b6]{[7]}. Urinomas and sub capsular bleeds have been reported in15-32\% of the patients who are treated with shock wave lithotripsy \hyperref[b7]{[8]}.Hollingsworth et al reported a 1.1\% overall prevalence of MET use between 2000 and 2006 in emergency departments in the USA, with a missed opportunity of sparing approximately 260,000 individuals annually from stone surgery \hyperref[b8]{[9]}. 70\% of urolithiasisare located in the lower third of the ureter. Determining factors for spontaneous passage of stones are their size, their configuration, and the smooth muscle activity of the ureters. In the transport of stones, the greatest obstacle is usually the terminal part of the ureters, mainly in the intramural 'detrusor tunnel. Antagonists of the alpha-1-adrenergic receptor, in particular, inhibit basal tone and decrease peristaltic frequency and amplitude with the consequences of increased fluid transport and decreased intra-ureteral pressure; they also block the conduction of visceral referred pain to the central nervous system, acting on C-fibres or sympathetic postganglionic neurons \hyperref[b9]{[10,}\hyperref[b10]{11,}\hyperref[b11]{12,}\hyperref[b12]{13]}. Both the European (EAU) and American Urological Associations (AUA) outline the role of alpha-blockers as a viable option in a select patient population who are comfortable with the approach and where there is no role for immediate surgical stone removal \hyperref[b13]{[14,}\hyperref[b14]{15]}. The role of alpha-blockersin MET has been well described \hyperref[b13]{[14]}\hyperref[b14]{[15]}. The role of adrenergic receptors in the human ureter was first described in 1970 \hyperref[b15]{[16]}. It was shown later, that the alpha-adrenergic receptors were classified into three different subtypes \&the distribution in the human ureter was ?1D >?1A >?1B \hyperref[b16]{[17]}. It was also shown that the alpha-adrenergic receptor agonists had a stimulatory effect on the ureteral smooth muscle, whereas the beta-adrenergic receptor agonists had an inhibitory effect \hyperref[b17]{[18]}. They prevent the uncoordinated muscle activity which is seen in renal colic, while maintaining ureteral peristalsis, which might facilitate a spontaneous stone passage \hyperref[b18]{[19]}. The treatment effect on the expulsion rate was partially lost, the sizes of the stones decreased, because of the high spontaneous expulsion rate of the small stones \hyperref[b1]{[2,}\hyperref[b19]{20]}. Our study included only solitary ureteral calculi \& located in the distal one third of the ureter. Current best practice guidelines recommend alpha-blockers for the expulsion of distal ureteral stones. Meta-analyses have demonstrated that patients treated with alpha-blockers are more likely to pass stones with fewer episodes of colic \hyperref[b7]{[8,}\hyperref[b20]{21]}. Two recent randomized controlled studies by Al-Ansari et al \hyperref[b21]{[22]} and Kaneko et al \hyperref[b22]{[23]} validated the efficacy of tamsulosin for distal ureteral calculi . However, a randomized control trial by Yilmaz et al demonstrated that tamsulosin, terazosin, and doxazosin were equally effective in distal stone expulsion in comparison to the control group \hyperref[b23]{[24]} .There is no role of tamsulosin or watchful waiting in stones of size ? 10mm \& Surgical intervention is the treatment of choice . In a recent study by Prof Robert Pickard et al \hyperref[b24]{[25]} where they gave tamsulosin for 4 weeks they found that 
\section[{V . Conclusion}]{V . Conclusion}\par
In our study incidence of ureteric calculi was found to be more in males in the age group of 31-40 years\& on the right side .Use of tamsulosin in MET for lower ureteric calculi upto 9mm helps in expulsion of stone, reduces the need for hospital admission, reduces pain, reduces the need for oral analgesics and reduces the need for surgical intervention. There was no significant difference in number of days required for expulsion of stones between two groups. There was no significant difference in mean size of stone passed in two groups. The possibility of expulsion of ureteric calculi spontaneously or with tamsulosin reduces as the stone size increases (maximum possibility with 5mm and minimum possibility with 9mm). There is no role of tamsulosin/watchful waiting in ureteric calculus of size ? 10mm. Most common Complications associated with tamsulosin are giddiness, retrograde ejaculation. Tamsulosin therapy is not cost effective than watchful waiting but cost effective than surgical intervention. However our study had only two groups, one study group and one control group. Adding two more groups simultaneously, one with some other alpha blocker drug and one with no drugs given at all, may show us the exact efficacy of tamsulosin Bibliography \begin{figure}[htbp]
\noindent\textbf{1} \par 
\begin{longtable}{P{0.85\textwidth}}
Year 2020\\
2\end{longtable} \par
  {\small\itshape [Note: ? Not meeting inclusion criteria (n=30) ? Declined to participate (n= 10) ? Other reasons (n=10) ? Received allocated intervention (n=314 )]} 
\caption{\label{tab_0}Table 1 :}\end{figure}
 \begin{figure}[htbp]
\noindent\textbf{2} \par 
\begin{longtable}{P{0.35676982591876205\textwidth}P{0.08056092843326886\textwidth}P{0.08056092843326886\textwidth}P{0.08056092843326886\textwidth}P{0.06576402321083172\textwidth}P{0.08549323017408124\textwidth}P{0.10029013539651838\textwidth}}
\tabcellsep Passed calculi in <14 days (\%)\tabcellsep Not passed calculi\tabcellsep Mean no. of colic episodes\tabcellsep Mean pain score\tabcellsep Need for hospitalisation during treatment\tabcellsep Need for surgical intervention\\
\multicolumn{2}{l}{groups Tamsulosin 260 (83.87\%)}\tabcellsep 50 (16.12\%)\tabcellsep 3 ± 1.7\tabcellsep 4.1 ± 1.7\tabcellsep 75\tabcellsep 55 (17.74\%)\\
WW\tabcellsep 195 (62.9\%)\tabcellsep 115 (37.09\%)\tabcellsep 4.2 ± 2.2\tabcellsep 5.1 ± 1.8\tabcellsep 135\tabcellsep 115 (37.09\%)\\
p value\tabcellsep <0.001\tabcellsep <0.001\tabcellsep < 0.001\tabcellsep < 0.001\tabcellsep <0.001\tabcellsep <0.001\\
\multicolumn{7}{l}{NCCT was done in 70 (22.58\%) cases in tamsulosin group and in 90 (29.03\%) cases in WW group as USG could not detect any}\\
\multicolumn{3}{l}{calculus. most of the stones detected by CT were of 5mm.}\tabcellsep \tabcellsep \tabcellsep \tabcellsep \end{longtable} \par
 
\caption{\label{tab_1}Table 2 :}\end{figure}
 		 		\backmatter  			  				\begin{bibitemlist}{1}
\bibitem[Weiss et al. ()]{b17}\label{b17} 	 		‘Adrenergic innervation of the ureter’.  		 			R M Weiss 		,  		 			A L Bassett 		,  		 			B F Hoffman 		.  	 	 		\textit{Invest. Urol}  		1978. 16 p. .  	 
\bibitem[Campschroer et al. ()]{b0}\label{b0} 	 		‘Alpha blockers as medical expulsive therapy for ureteral stones’.  		 			T Campschroer 		,  		 			Y Zhu 		,  		 			D Duijvesz 		,  		 			D E Grobbee 		,  		 			Mtwt Lock 		.  	 	 		\textit{Cochrane Database Syst Rev}  		2014. 4  (CD008509) .  	 
\bibitem[Malin et al. ()]{b15}\label{b15} 	 		‘Characterisation of adrenergic receptors in human ureter’.  		 			J M MalinJr 		,  		 			R F Deane 		,  		 			S Boyarsky 		.  	 	 		\textit{Br. J. Urol}  		1970. 42 p. .  	 
\bibitem[Eisner et al. ()]{b4}\label{b4} 	 		‘Contemporary management of ureteral stones’.  		 			R 		,  		 			M J Eisner 		,  		 			B Porpiglia 		,  		 			F Preminger 		,  		 			G M Tiselius 		,  		 			H-G 		.  	 	 		\textit{Eur Urol}  		2012. 61 p. 764V.  	 	 (in Article Summary) 
\bibitem[Kaneko et al. ()]{b22}\label{b22} 	 		‘Efficacy of low dose tamsulosin in medical expulsive therapy for ureteral stones in Japanese male patients: A randomized controlled study’.  		 			T Kaneko 		,  		 			H Matsushima 		,  		 			H Morimoto 		.  	 	 		\textit{Int Urol}  		2010. 17 p. .  	 
\bibitem[Al-Ansari et al. ()]{b21}\label{b21} 	 		‘Efficacy of tamsulosin in the management of lower ureteral stones: A randomized double-blind placebocontrolled study of 100 patients’.  		 			A Al-Ansari 		,  		 			A Al-Naimi 		,  		 			A Alobaidy 		.  	 	 		\textit{J Urol}  		2010. 75 p. .  	 
\bibitem[Ghani et al. ()]{b2}\label{b2} 	 		‘Emergency department visits in the United States for upper urinary tract stones: trends in hospitalization and charges’.  		 			K R Ghani 		,  		 			F Roghmann 		,  		 			Sammon 		.  	 	 		\textit{J Urol}  		2014. 191 p. .  	 
\bibitem[Itoh et al. ()]{b16}\label{b16} 	 		‘Examination of alpha 1 adrenoceptor subtypes in the human ureter’.  		 			Y Itoh 		,  		 			Y Kojima 		,  		 			T Yasui 		,  		 			K Tozawa 		,  		 			S Sasaki 		,  		 			K Kohri 		.  	 	 		\textit{Int. J. Urol}  		2007. 14 p. .  	 
\bibitem[Turk et al. (2014)]{b13}\label{b13} 	 		\textit{Guidelines on urolithiasis. European Association of Urology},  		 			C Turk 		,  		 			T Knoll 		,  		 			A Petrik 		.  		2014. Accessed December 1, 2014.  	 
\bibitem[Preminger et al.]{b14}\label{b14} 	 		\textit{Management of ureteral calculi},  		 			G M Preminger 		,  		 			H G Tiselius 		,  		 			G Assimos 		.  		EAU-AUA nephrolithiasis.  	 
\bibitem[Lotan et al. ()]{b7}\label{b7} 	 		‘Management of ureteral calculi: A cost comparison and decision making analysis’.  		 			Y Lotan 		,  		 			M T Gettman 		,  		 			C G Roehrborn 		,  		 			J A Cadeddu 		,  		 			M S Pearle 		.  	 	 		\textit{J Urol}  		2002. 167 p. 1621.  	 
\bibitem[Tzortzis et al. ()]{b18}\label{b18} 	 		‘Medical expulsive therapy for distal ureteral stones’.  		 			V Tzortzis 		,  		 			C Mamoulakis 		,  		 			J Rioja 		,  		 			S Gravas 		,  		 			M C Michel 		,  		 			J J De La Rosette 		.  	 	 		\textit{Drugs}  		2009. 69 p. .  	 
\bibitem[Dellabella et al. ()]{b9}\label{b9} 	 		‘Medical expulsive therapy for distal ureterolithiasis: Randomized prospective study on role of corticosteroids used in combination with tamsulosin Role of Short Term Tamsulosin in Medical Management of Lower Ureteric Calculi in Today's Modern Era of Increasing Demand of Various Advancing Endo-Urological Procedures -simplified treatment regimen and health related quality of life’.  		 			M Dellabella 		,  		 			G Milanese 		,  		 			G Muzzonigro 		.  	 	 		\textit{Urology}  		2005. 66 p. .  	 
\bibitem[Seitz et al. ()]{b1}\label{b1} 	 		‘Medical therapy to facilitate the passage of stones: what is the evidence’.  		 			C Seitz 		,  		 			E Liatsikos 		,  		 			F Porpiglia 		,  		 			H-G Tiselius 		,  		 			U Zwergel 		.  	 	 		\textit{Eur Urol}  		2009. 56 p. .  	 
\bibitem[Hollingsworth et al. ()]{b5}\label{b5} 	 		‘Medical therapy to facilitate urinary stone passage: a meta-analysis’.  		 			J M Hollingsworth 		,  		 			M A Rogers 		,  		 			Kaufman 		,  		 			Sr 		.  	 	 		\textit{Lancet}  		2006. 368 p. .  	 
\bibitem[Kinnman et al. ()]{b12}\label{b12} 	 		‘Peripheral alpha-adrenoreceptors are involved in the development of capsaicin induced ongoing and stimulus evoked pain in humans’.  		 			E Kinnman 		,  		 			E B Nygårds 		,  		 			P Hansson 		.  	 	 		\textit{Pain}  		1997. 69 p. .  	 
\bibitem[Prof Robert Pickard et al. (2015)]{b24}\label{b24} 	 		‘Prof Samuel McClinton, MD .Medical expulsive therapy in adults with ureteric colic: a multicentre, randomised, placebo-controlled trial’.  		 			Kathryn Prof Robert Pickard 		,  		 			Graeme Starr 		,  		 			Thomas Maclennan 		,  		 			Ruth Lam 		,  		 			Jennifer Thomas 		,  		 			Gladys Burr 		,  		 			Alison Mc Pherson 		,  		 			Kenneth Mcdonald 		,  		 			Prof Anson 		,  		 			N' James 		,  		 			Neil Dow 		,  		 			Terry Burgess 		,  		 			Mary Clark 		,  		 			Katie Kilonzo 		,  		 			Kirsty Gillies 		,  		 			Charles Shearer 		,  		 			Boachie 		.  	 	 		\textit{Lancet}  		2015 Jul 25. 386  (9991)  p. .  	 
\bibitem[Ueno et al. ()]{b19}\label{b19} 	 		‘Relation of spontaneous passage of ureteral calculi to size’.  		 			A Ueno 		,  		 			T Kawamura 		,  		 			A Ogawa 		,  		 			H Takayasu 		.  	 	 		\textit{Urology}  		1977. 10 p. 544.  	 
\bibitem[Ishigooka et al. ()]{b11}\label{b11} 	 		‘Spinal substance P immunoreactivity is enhanced by acute chemical stimulation of the rat prostate’.  		 			M Ishigooka 		,  		 			T Nakada 		,  		 			T Hashimoto 		,  		 			Y Iijima 		,  		 			H Yaguchi 		.  	 	 		\textit{Urology}  		2002. 59 p. .  	 
\bibitem[Yilmaz et al. ()]{b23}\label{b23} 	 		‘The comparison and efficacy of 3 different alpha1-adrenergic blockers for distal ureteral stones’.  		 			E Yilmaz 		,  		 			E Batislam 		,  		 			M M Basar 		.  	 	 		\textit{J Urol}  		2005. 173 p. .  	 
\bibitem[Autorino et al. ()]{b20}\label{b20} 	 		‘The use of tamsulosin in the medical treatment of ureteral calculi: Where do we stand?’.  		 			R Autorino 		,  		 			Sio De 		,  		 			M Damiano 		,  		 			R 		,  		 			Di Lorenzo 		,  		 			G Perdonà 		,  		 			S Russo 		,  		 			A 		.  	 	 		\textit{Urol Res}  		2005. 33 p. .  	 
\bibitem[Hollingsworth et al. ()]{b8}\label{b8} 	 		‘Trends in medical expulsive therapy use for urinary stone disease in U.S. emergency departments’.  		 			J M Hollingsworth 		,  		 			M M Davis 		,  		 			B T West 		,  		 			J S Wolf 		,  		 			Jr 		,  		 			B K Hollenbeck 		.  	 	 		\textit{Urology}  		2009. 74 p. .  	 
\bibitem[UK Government Department of Health. NHS reference costs ()]{b3}\label{b3} 	 		\textit{UK Government Department of Health. NHS reference costs},  		 \url{https://www.gov.uk/government/publications/nhs-reference-costs-2012-to-2013.}  		2012. 2013. 2014. 20.  	 	 (accessed Sept) 
\bibitem[Morita et al. ()]{b10}\label{b10} 	 		‘Ureteral urine transport: changes in bolus volume, peristaltic frequency, intraluminal pressure and volume of flow resulting from autonomic drugs’.  		 			T Morita 		,  		 			I Wada 		,  		 			H Saeki 		,  		 			S Tsuchida 		,  		 			R M Weiss 		.  	 	 		\textit{J Urol}  		1987. 137 p. .  	 
\bibitem[Daniels et al. ()]{b6}\label{b6} 	 		‘Ureteroscopic results and complications: experience with 130 cases’.  		 			G F DanielsJr 		,  		 			J E Garnett 		,  		 			M F Carter 		.  	 	 		\textit{J. Urol}  		1988. 139 p. .  	 
\end{bibitemlist}
 			 		 	 
\end{document}
