SYNOPSIS

OF
DISSERTATION
“A RANDOMIZED CONTROL TRAIL
COMPARING
TAMSULOSIN AND SILODOSIN IN MEDICAL
EXPULSIVE THERAPY FOR URETERIC
STONES”

Name of PG Guide

Dr. Narayan Umale

Head of Department
Department of Surgery

Submitted By

Dr. Ashish R Chandak

Surgery Resident
Department of Surgery
Name of Candidate DR. ASHISH RAMESHKUMAR CHANDAK

Name of College DR. PANJABRAO ALIAS BHAUSAHEB

DESHMUKH MEMORIAL MEDICAL
COLLEGE, AMRAVATI, MAHARASHTRA-
444603.
Name of Guide DR. NARAYAN UMALE
Name of Course MASTER OF SURGERY
Name of Subject GENERAL SURGERY
Admission Year/ 2019
Academic Year

Topic :- “A RANDOMIZED CONTROL TRAIL

COMPARING TAMSULOSIN AND SILODOSIN IN
MEDICAL EXPULSIVE THERAPY FOR URETERIC
STONES”
 MAHARASHTRA UNIVERSITY OF HEALTH SCIENCES, NASHIK

SYNOPSIS OF DISSERTATION

“A RANDOMIZED CONTROL TRAIL COMPARING TAMSULOSIN AND

SILODOSIN IN MEDICAL EXPULSIVE THERAPY FOR URETERIC
STONES”

Name of PG Guide

Dr. Narayan Umale

Head of Department
Department of Surgery

Submitted By

Dr. Ashish R Chandak

Surgery Resident
Department of Surgery

SIGNATURE OF GUIDE SIGNATURE OF CANDIDATE

Dr. Narayan Umale Dr. Ashish Chandak

SIGNATURE OF HOD
Dr. Narayan Umale

TO,
THE CHAIRPERSON AND MEMBERS,
ETHICAL COMMITTEE,
DR. PDMMC, AMRAVATI

SUBJECT: FOR APPROVAL OF DISSERTATION TOPIC

RESPECTED SIR/MADAM,

I, DR. ASHISH RAMESHKUMAR CHANDAK POSTGRADUATE STUDENT OF 2019

BATCH IN M.S. GENERAL SURGERY REQUEST YOU TO KINDLY ACCEPT AND
APPROVE MY DISSERTATION TOPIC AS FOLLOWS UNDER THE GUIDANCE OF
DR.NARAYAN UMALE (DEPARTMENT OF SURGERY) , DR. PDMMC, AMRAVATI.

TITLE: “A RANDOMIZED CONTROL TRAIL COMPARING TAMSULOSIN AND

SILODOSIN IN MEDICAL EXPULSIVE THERAPY FOR URETERIC STONES”

THANKING YOU,

YOUR’S SINCERELY,
DR. ASHISH RAMESHKUMAR CHANDAK
DATE:
 INTRODUCTION

The Urinary stone disease is one of the most common afflictions of the modern
society and it has been described since antiquity with the westernization of global
culture. Afflicting 13% of men and 7% of women. (1)The life-time risk of urinary
stone disease is estimated to be between 5% and 12% in Europe and US, among
all urinary tract stones, 20% present as ureteral stones, of which 70% are found in
the lower third of the ureter. (2)The efficacy of mini-invasive therapies, such as
Extracorporeal Shock Wave Lithotripsy [ESWL] and ureteroscopy has been proven
by several studies.(3) Nevertheless these techniques are not risk free, are
problematic and are quite expensive.(4)Recently, the use of watchful waiting
approach has been extended by using Pharmacotherapy. This can reduce
symptoms and facilitate stone expulsion.(5)

Both the AUA (6)and the European Association ofUrology (EAU) (7)recommend a-
blockers for the treatmentof ureteric stones. Recently, the α1A-
adrenoceptorsubtype has been shown to play the major role in
mediatingphenylephrine-induced contraction of the humanisolated ureter (8). In
the human ureter, silodosin(a selective α1-adrenoceptor blocker) was found to
bemore effective than an a1D-adrenoceptor blocker in noradrenaline-induced
contraction (9).

However, published data are limited on the use of silodosin as MET for Ureteric
Stones; thus we conducted a prospective randomized study to compare the
efficacy and safety of silodosin vs tamsulosin as MET for single, symptomatic,
uncomplicated ureteric stones in adults.
REVIEW OF LITERATURE:

Sandeep gupta et al:

In our study, silodosin was found to be clinically superior to tamsulosin, both in
terms of the stone expulsion rate and the stone expulsion time (13)

Dr Arun Antony et al :
The stone clearance rate was significantly higher in the silodosin group
compared with the tamsulosin group, at 53% and 34%, respectively (P = 0.009) (14)

Garib T. et al (2018)-
Silodosin showed better results against tamsulosin as stone expulsion rate in
silodosin and tamsulosin groups was 82.4 and 61.5% respectively with significant
difference (p = 0.007). Also, the stone expulsion time was significantly lower in
silodosin against tamsulosin groups as it was 9.4 ± 3.8 vs. 12.7 ± 5.1 days in group
I and II respectively (p = 0.001). The adverse effects were comparable with non-
significant more retrograde ejaculation in the silodosin group. Silodosin showed
better efficacy in the stone expulsion rate and time with comparable safety of
both drugs, with nonsignificant more retrograde ejaculation in silodosin (15).
Aim:-

To prospectively study by comparing Tamsulosin and Silodosin in Medical

Expulsive Therapy for Ureteric Stones.

Objective:-
To study the outcomes of Medical Expulsive Therapy for Ureteric Stones by
comparing Tamsulosin and Silodosin.

Materials and Methods:-

Type of Study:- Randomized control trail

Study of Population:- All patients admitted in surgery ward of hospital having

ureteric stones are included after applying following inclusion and exclusion
criteria

Study Setting:- Tertiary care hospital

Source of Data:- Male and Female patients admitted in surgery ward and willing
to participate in the study

Duration of Study:- 1 year

Sampling Method:- Random Sampling with Random allocation in 2 groups by odd

and even method with single blind

Sample Size:- Open Epi Version 3, with mean and standard deviation of group 1-
9.4 and 3.8, group 2 – 12.7 and 5.1 with 95% confidence interval and power of
80% , total size is 60 , 30 in each group ( ratio 1:1 )
Inclusion criteria:-

1. Male or female patients aged 20 and over.

2. Patients having ureteral calculi located in ureter on ultrasonography of kidney,

ureter and bladder.

3. Patients whose calculi measures 10 mm and less.

4. Patients who voluntarily decide to take part in this study and give written
consent.

Exclusion criteria:-
1. Patients who did not give consent and were not willing to take part in the
study.

2. Pregnant women or nursing mothers.

3.Patients with febrile UTI or severe hydronephrosis or ulcerative disease or

hypotension.

4. Patients on α-blockers or α/β blockers or CCB or steroid.

5. Patients whose urinary tracts are anatomically deformed or stenosed.

6. Patients who underwent invasive operation on their ureter before.

7. Patients whose blood creatinine levels are 1.4 mg/dl and over.

8. Single renal patients.

9. Pain resistant to conservative treatment (non-tolerant patients).

10. Patients with NSAID drug intolerance or adverse effects of Tamsulosin/

Silodosin during study.

11. Patient withdrew from the study at any time.

Data Collection Procedure:-

All patients were diagnosed by plain abdominal radiograph of the kidneys, ureters
and bladder (KUB), ultrasonography, and non-enhanced spiral CT (in somecases).
Every patient provided informed written consentafter receiving information about
the nature of thestudy, time to study end, adverse effects, and the possibilityof
intervention if needed.

Patients will be randomized into two equal groups,50% patients received a daily
single dose of tamsulosin 0.4 mg for 28 days and50% patients received a daily
single dose of silodosin 8 mg for 28 days.

Post Therapeutic Examination:-Each Patient will be followed after 1week,

2week and 28days.

Statistical Analysis:-

Data will be entered in MS Excel and will be analysed using SPSS software AND
appropriate test of significance will be applied.
PROFORMA [confidential]

Name:-

Age: Sex: Occupation Reg. No.:

Address: Contact No.:

Chief Complaints:-

History of Present Illness:-

Past History:-

Hypertension DM Asthma TB Fever

Personal History:-

Diet: Job Profile(Sedentary/ Non-Sedentary)

B/B:

Addiction:

Family History:-
General Examination:-

Mental State: Nutritional Status:

Temp.

Pulse: BP: Respiratory Rate:

Pallor edema lcterus Cyanosis Clubbing

Lymphadenopathy

General Examination:-

CVS

CNS

RS

P-A Examination

Provisional Diagnosis:-

Investigations:-

CBC

LFT KFT

Blood Sugar Sr. Electrolytes

HBsAg HIV

Urine(R)
Plain abdominal radiograph of the kidneys, ureters and bladder (KUB)

Abdominal Sonography:-

Non-enhanced C.T. Scan of Abdomen (in some cases)

Post Therapeutic Follow-Up:-

1 week

2 weeks

28 days.
References:-
1. Hollingsworth J. M, Rogers MA, Kaufman SR et al. Medical therapy to facilitate
urinary stone passage: a meta-analysis. Lancet. 2006; 368: 1171-79.

2. Wolf JS Jr. Treatment selection and outcomes: ureteral calculi. Urol Clin North
Am 2007; 34: 421-30.

3. Mille, O. F and Kane, D. J Time to stone passage for observed ureteral calculi;
aguide for patient education. J. Urol, 162:688, 1999.

4. Lotan, Y., Gettman, M. T., Roehroborn, C. G., Cadeddu, J. A. and Pearle, M. S.:
Mangagement of urteral calculi: a cost comparison and decision making
analysis. J. Urol, 167: 1621, 2002.

5. Borghi, L., Meschi, T., Amato, F., Novarini, A., Giannini, A., Quarantelli, C. et al:
Nifedipine and methylprednislone in facilitating ureteral stone passage: a
randomized double blind, placebo controlled study. J. Urol, 152: 1095, 1994.

6. American Urological Association. Ureteral Calculi: 2007 Guidelinefor the

Management of Ureteral Calculi, EAU/AUA Nephrolithiasis Panel. Available at:
https://www.auanet.org/common/ pdf/education/clinical- guidance/Ureteral-
Calculi.pdf; 2007 [accessed January 2014].

7. Tiselius HG, Ackermann D, Alken P, Buck C, Conort P, Gallucci M, et al.

Guidelines on urolithiasis. Eur Urol2001;40:362–71.

8. Sasaki S, Tomiyama Y, Kobayashi S, Kojima Y, Kubota Y, Kohri K.

Characterization of a1-adrenoceptor subtypes mediating contraction in human
isolated ureters. Urology 2011;77, 762. e13-7.

9. Kobayashi S, Tomiyama Y, Hoyano Y, Yamazaki Y, Kusama H, Itoh Y, et al. Gene

expressions and mechanical functions of a1- adrenoceptor subtypes in mouse
ureter. World J Urol2009;27:775–80.
10.Porpiglia F, Destefanis P, Fiori C, Fontana D. Effectiveness ofnifedipine and
deflazacort in the management of distal ureter stones. Urology 2000;56:579–
83.

11.Dellabella M, Milanese G, Muzzonigro G. Randomized trial ofthe efficacy of

tamsulosin, nifedipine and phloroglucinol inmedical expulsive therapy for
distal ureteral calculi. J Urol2005;174:167–72.

12.Griwan MS, Singh SK, Paul H, Pawar DS, Verma M. Theefficacy of tamsulosin in
lower ureteral calculi. Urol Ann2010;2:63–6.

13.Sandeep Gupta et al, J Clin Diagn Res. 2013 Aug; 7(8): 1672–1674.

14.Dr Arun Antony et al JMSCR Dec2017;05:31928-32

15.Garib T. et al.Comparitive study between Sildonosin and Tamsulosin in

expectant therapy of distal ureteral stone Urol. Int 2018;101:161-166

16.Tsuzaka Y, Matsushima H, Kaneko T, et al. Naftopidil vs silodosin in medical

expulsive therapy for ureteral stones: a randomized controlled study in
Japanese male patients. Int J Urol. 2011; 18: 792-5.

17.Vittorio Imperatore, Ferdinando Fusco, Massimiliano Creta et al.

ArchivioItaliano di Urologia e Andrologia 2014; 86, 2, 105.

18.Ahmed AF, Al-Sayed AY. Tamsulosin versus alfuzosin in thetreatment of

patients with distal ureteral stones: prospective,randomized, comparative
study. Korean J Urol2010;51:193–7.

19.Yilmaz E, Batislam E, Basar MM, Tuglu D, Ferhat M, Basar H.The comparison

and efficacy of 3 different alpha1-adrenergicblockers for distal ureteral stones.
J Urol2005;173:2010–2.
20.Al-Ansari A, Al-Naimi A, Alobaidy A, Assadiq K, Azmi MD,Shokeir AA. Efficacy of
tamsulosin in the management of lowerureteral stones: a randomized double-
blind placebo-controlledstudy of 100 patients. Urology 2010;75:4–7.

21.Agrawal M, Gupta M, Gupta A, Agrawal A, Sarkari A, LavaniaP. Prospective

randomized trial comparing efficacy of alfuzosinand tamsulosin in
management of lower ureteral stones. Urology2009;73:706–9.

22.Coll DM, Varanelli MJ, Smith RC. Relationship of spontaneouspassage of

ureteral calculi to stone size and location as revealed byunenhanced helical CT.
AJR Am J Roentgenol 2002;178, 101e5.

23.Abdel-Meguid TA, Tayib A, Al-Sayyad A. Tamsulosin to treat uncomplicated

distal ureteral calculi: a double blind randomized placebo-controlled trial. Can J
Urol. 2010; 17:5178-83.

24.Yu HJ, Lin AT, Yang SS et al. Non-inferiority of silodosin to tamsulosin in

treating patients with lower urinary tract symptoms (LUTS) associated with
benign prostatic hyperplasia (BPH). BJU Int. 2011; 108:1843-8.).

25.Schilit S, Benzeroual KE. Silodosin: a selective alpha1A-adrenergic receptor

antagonist for the treatment of benign prostatic hyperplasia. Clin Ther. 2009;
31: 2489-502.

26.Chapple CR. A Comparison of Varying alpha-Blockers and Other

Pharmacotherapy Options for Lower Urinary Tract Symptoms. Rev Urol. 2005;
7 Suppl 4:S22-30.
 CONSENT FORM

1. I am willing to participate as one of the case for this research study entitled
A PROSPECTIVE STUDY COMPARING TAMSULOSIN AND
SILODOSIN IN MEDICAL EXPULSIVE THERAPY FOR URETERIC
STONES.

2. I have been informed in detail about this research study by audio-visual

means.

3. I have also been informed about the various complications- medical or

technical, temporary or permanent, immediate or long term, etc. which may
arise during the course of this study and has been allowed to ask questions
regarding the study.

4. This has been explained to me in the language of my understanding.

5. After understanding all information, I am signing this consent letter without

any force or coercion.

Signature of the Patient:-

Date:-

Signature of Witness:-
Date:-
 अनुमतिपत्र

1. मै इस्अनु मतिपत्रद्वाराA PROSPECTIVE STUDY COMPARING

TAMSULOSIN AND SILODOSIN IN MEDICAL EXPULSIVE
THERAPY FOR URETERIC
STONES इस्वै द्यकियउपक् रममे शामिलहोने किसहमतिदे रहाह।ू

2. मु झेइसउपक् रमकिपु रीजनकरीदीगईहै औरइसमे अवश्यकसभीप्रकारकिजाचे तथाइन

किगभीरताएवमसम्भवितहानिसे अवगतकियागयाहै ।

3. इसउपक् रमकेदरम्यानहोने वालीसभीदुष्परिणाम; तकनीकीयावै द्यकीय,

स्थायियाअस्थायि,
तु रन्तयादुरगामीकेबारे मे मुझेजानकारीदीगईहै औरमु झेपर् श्नपूछ्नेकामौकादियागया
है ।

4. मै यहसभीजनकरीसमझने केबादपु रे होशो-हवासमे स्वखु शिसे इसअनु मति-

पत्रपरसहिकररहाहु।

गवाहकेहस्ताक्षर
दिनांक:

मरीजकेहस्ताक्षर
दिनांक:
 संमतीपत्र

1. मीयासं मतीपत्रमध्यमने A PROSPECTIVE STUDY COMPARING

TAMSULOSIN AND SILODOSIN IN MEDICAL EXPULSIVE
THERAPY FOR URETERIC
STONES यासं शोधनात्मकअभ्यासातभागघे नाराएकरुग्नम्हनु नसम्मतीदे तआहे .

2. यासं शोधनात्मकअभ्यासाचीमाहितीमलादिलीआहे .
यातआवश्यकअसले ल्यासगद्याचाचन्यावत्याचीसम्भावितहानीबद्दलमलाकल्पनादिले
लीआहे .

3. याअभ्यासादरम्यानविविधगु ं तागु ं तबद्दल-वै द्यकीयआणितां त्रिक,

त्वरितकिंवादीर्घकालीन,तात्पु रतीकिंवाकायमचीपरिनामाचीमाहितीमलादिले लीआहे
वमलाप्र्श्नविचारन्याचीसन्धीदिले लीआहे .

4. हीसर्वमाहितीसमजल्यानतरमीस्वखु शीने यासम्मतिपत्रवरस्वाक्षरीकरतआहे .

साक्षीदाराचीस्वाक्षरी
दिनांक:

रुग्नाचीस्वाक्षरी
दिनांक: