To, Date:15/09/2021

The Chairperson,
Ethical Committee,
R. G. Kar Medical College & Hospital
Kolkata – 700004.

Subject - Application for Ethical Committee clearance for thesis research.

Respected Sir,
This is to inform you that I, Dr Kunjan Kumar, 1 st year MCh PDT (Urology),
R. G. Kar MC&H, Kolkata am submitting my thesis synopsis with the topic of
“EVALUATION OF MULTIPARAMETRIC MRI FOR DIAGNOSIS AND STAGING
OF BLADDER CANCER” for M.Ch. Urology, session 2020-2023.
My Guide is Dr. Ranjan Kumar Dey (Professor, Dept. of Urology, R. G. Kar MC&H,
Kolkata).

My place of work is RGKMC&H, Kolkata.

I humbly request you to kindly allow ethical clearance of my thesis for further processing.

Thanking you,
Yours sincerely,

Dr Kunjan Kumar
PDT (Urology), R. G. Kar Medical College & Hospital.

1
 EVALUATION OF MULTIPARAMETRIC MRI
FOR DIAGNOSIS AND STAGING OF URINARY
BLADDER CANCER

RESEARCH PROTOCOL (SYNOPSIS OF DISSERTATION) FOR THE

DEGREE OF M.Ch.(UROLOGY)
WEST BENGAL UNIVERSITY OF HEALTH SCIENCES
(SESSION 2020-2023)

SUBMITTED BY:
DR KUNJAN KUMAR
M.B.B.S, M.S. (GENERAL SURGERY)

GUIDE – DR RANJAN K. DEY

PROFESSOR, DEPT OF UROLOGY
R.G. KAR MEDICAL COLLEGE, KOLKATA.

R.G. KAR MEDICAL COLLEGE, KOLKATA – 04.

THESIS TOPIC

2
 STUDY OF MULTIPARAMETRIC MRI FOR DIAGNOSIS AND
STAGING OF URINARY BLADDER CANCER

SUMMARY OF PROPOSAL

Bladder cancer (BC) is one of the most common malignancy among men, and the most

common urinary malignancy. As per extant treatment guidelines, it is commonly categorized

as muscle-invasive and non-muscle invasive bladder cancer. Muscle invasion status is the

single most important prognostic factor and determinant of survival in bladder cancer.

Though contrast-enhanced CT of the urinary bladder is the standard investigation for

diagnosis and staging of bladder cancer, it has poor sensitivity in the diagnosis of muscle

invasion, and MRI, which has much better soft tissue resolution, may be of better value in

this regard.

Recently, a newer MRI protocol called multiparametric MRI with the vesical imaging –

reporting and data system (VI-RADS) has been developed and has been shown to have good

predictive value for muscle invasion of bladder cancer. It may be extremely valuable in its

early diagnosis and staging, but needs further evaluation and validation with the study of

concordance between imaging and histopathological findings.

CONTENTS

1. Introduction------------------------------------------------------------ 4

2. Aims & Objectives------------------------------------------------------- 7

3
 3. Materials & Methods----------------------------------------------------- 8

4. Review of literature------------------------------------------------------ 11

5. References------------------------------------------------------------- 17

6. Consent form(English)--------------------------------------------------- 21

7. Consent form(Hindi)----------------------------------------------------- 22

8. Consent form(Bengali)--------------------------------------------------- 23

9. Case record form------------------------------------------------------- 24

INTRODUCTION

Bladder cancer (BC) is the 4th most common malignancy among men, and 10th most common

cancer overall in the world [1,2]. It is also the second most common genitourinary

malignancy after prostate cancer, and the most common urinary malignancy. Urothelial or

4
transitional cell carcinoma of the urinary bladder (UB) accounts for more than 90% of these,

with squamous cell carcinoma (6-8%) and adenocarcinoma (~2%) being rarer causes.

BC is broadly divided into non-muscle invasive (NMIBC) and muscle-invasive (MIBC)

subtypes. 70% to 80% of newly-diagnosed patients of BC have non-muscle invasive disease,

with 5-year survival rates exceeding 90% [1,2,5]. MIBC accounts for 20% to 30% of newly

diagnosed cases of BC, with 5-year survival rates of less than 50% [2,5]. The standard

management for NMIBC is trans-urethral resection(TUR) with or without intravesical

chemotherapy or immunotherapy, while MIBC is managed with radical cystectomy(open or

laparoscopic/robotic). Thus, correct diagnosis of the status of muscle invasion as early as

possible is crucial for appropriate management of BC.

The first-line investigation for diagnosis of BC is cystoscopy and imaging – with

ultrasonography of the kidneys and the urinary bladder (KUB) the initial modality and

contrast-enhanced CT(CECT) urography the gold standard investigation [3,10,11]. CT

urography is more than 90% sensitive and specific for diagnosis of bladder tumours.

However, the accuracy of CECT in the local staging of bladder is lower, and MR imaging is

considered superior to CT in demonstrating the presence and extent of muscle invasion in BC

[3,4].

The diagnostic accuracy of conventional or contrast-enhanced MRI is not very encouraging.

However, a multiparametric (mpMRI) approach with both conventional and functional

sequences including T2-weighted images(T2WI), diffusion-weighted imaging (DWI), and

dynamic contrast enhancement (DCE) has significantly better results in diagnosing and

accurately staging muscle-invasive BC. To improve the interpretation of bladder mpMRI, the

vesical imaging – reporting and data system (VI-RADS) has been developed [12,13]. MpMRI

5
is a newer modality, and there is insufficient data available as yet regarding its uses and

application in the clinical scenario [10,11].

Owing to the lack of data regarding the VI-RADS, its accuracy and usage, both

internationally and in the Indian milieu, a prospective study in the east Indian population is

planned.

LACUNAE IN THE EXISTING KNOWLEDGE

Early and accurate staging of bladder cancer is essential for appropriate treatment of the

disease. The presence and extent of muscle invasion is the single most important factor. The

available literature is mostly focused on the acquisition and interpretation of MRI images,

with few concerned with the concordance of MRI and histopathological findings. The

application of mpMRI and the VI-RADS in the Indian population has rarely been a subject of

study.

6
 AIMS & OBJECTIVES

1. To evaluate the accuracy of mpMRI in the diagnosis and local staging of muscle

invasion in patients of bladder cancer.

2. To study the concordance of MRI and histopathological findings in patients

treated for bladder cancer.

3. To evaluate the usefulness of mpMRI in the prognostication of bladder cancer.

7
 MATERIALS AND METHODS

STUDY DESIGN – This is a prospective study.

STUDY PERIOD - The study period will be from September 2021 to

April 2023.

STUDY VENUE - The study is proposed to be conducted in the Dept.

of Urology, R.G. Kar Medical College & Hospital.

STUDY POPULATION - Patients of bladder cancer attending the Urology

OPD or admitted to the Urology wards.

SAMPLE SIZE - After applying inclusion and exclusion criteria, 30

patients of bladder cancer will be

enrolled in the study.

8
METHODOLOGY:

30 patients diagnosed with bladder cancer will be worked up on an OPD/IPD basis. After

detailed history and clinical examination, they will undergo multiparametric MRI in the

department of Radiology, R.G. Kar Medical College & Hospital. Having been diagnosed and

staged on the basis of imaging, they will be treated with trans-urethral resection (TUR) or

trans-urethral biopsy from bladder lesion including deep muscle tissue biopsy. The MRI

findings will be compared to the histopathological examination (HPE) findings.

The patients will be further managed and followed up as per current extant guidelines for

bladder cancer management.

Plan for Data Analysis:

Collected data will be analyzed by using standard statistical techniques.

INCLUSION CRITERIA:

1. Adult patients presenting to the urology OPD/IPD with or without haematuria, with

UB space-occupying lesion (SOL) diagnosed radiologically.

2. Patients treated previously for UB cancer presenting with recurrence of disease.

EXCLUSION CRITERIA:

9
 1. Patients unwilling or unable to undergo surgery (TUR/biopsy).

2. Patients unable to undergo MRI for any reason.

3. Patients presenting for the first time with urinary bladder SOL of size less than 3 cm.

4. Patients with obvious extravesical extension of tumour or distant metastasis found on

prior imaging.

5. Patients who have undergone prior radical cystectomy(open/laparoscopic).

PATIENT SAFEGUARDS / CONFIDENTIALITY:

All the patients will be informed of the ongoing study. Only patients who give a written

informed consent for inclusion in the study will be included. Patients’ confidentiality will be

respected throughout the study. No names will be published in medical / nonmedical

literature.

10
 REVIEW OF LITERATURE

Cancer of the urinary bladder is the 4th most common malignancy affecting men in the

western world, 8th most common among women, and 10th overall [1]. It is 4 times

more common among men compared to women, and causes 3.2/100,000 deaths

annually among men and 0.9/100,000 deaths among women [1,2]. Of all cases of BC,

transitional cell carcinoma (TCC) or urothelial carcinoma accounts for more than

90%, with squamous cell carcinoma comprising 6% to 8% of cases and

adenocarcinoma 2% [3]. Some of the well-established risk factors for bladder cancer

include cigarette smoking and tobacco usage, occupational exposure to aniline dyes,

benzidene compounds, analgesic abuse (phenacetin) and chronic irritation, such as

indwelling catheters. Squamous cell carcinoma is commonly associated with chronic

infections, especially Schistosoma haematobium infection seen in the Middle East and

north Africa, and adenocarcinoma seen in urachal remnants [2,5].

Patients with BC present with haematuria in more than 90% of cases. Owing to its

earlier symptomatic presentation compared to many other malignancies, and its being
11
detectable with imaging/cystoscopy, BC can be treated with resection with good

survival rates [4,5].

70% to 80% of newly diagnosed patients of BC present with superficial or non-

muscle invasive BC(NMIBC), which has 5-year survival rates of 82-100% [5,6,7].

NMIBC is generally treated with trans-urethral resection. However, recurrence rates

are high in NMIBC, with 50-70% of patients experiencing recurrent disease after

complete resection [7,8].

20-30% of newly diagnosed patients of BC present with muscle invasive disease,

which has poorer survival (60-80% in T2 tumours) [6,7]. The standard treatment of

MIBC is considered to be radical cystectomy with urinary diversion, although TUR

followed by chemoradiotherapy with bladder preservation, the so-called trimodality

therapy (TMT) may be considered in some cases [8,9].

Thus, accurate staging is critical, as prognosis and management of patients with BC

largely depends on the local tumor stage and the presence of lymph node (LN) or

distant metastases. However, there is a substantial discrepancy between preoperative

clinical staging (combined bimanual examination, TURBT, and conventional

imaging) and the final pathologic staging based on radical cystectomy and LN

dissection with an inaccuracy rate of 23–50% [13], mainly due to understaging of

both the depth of local invasion and LN metastatic involvement.

Magnetic resonance imaging (MRI) is being increasingly used for the preoperative,

local staging of BC due to its high soft-tissue contrast resolution, and the ability to

assess the depth of bladder wall invasion, with a recent meta-analyses reporting a high

diagnostic performance in differentiating NMIBC from MIBC, as well as for

predicting extravesical extension [3,24,28]. However, sensitivity for detecting LN

metastases remains unsatisfactory due to an overreliance on size criteria. As per EAU

12
guidelines, the role of multi-parametric magnetic resonance imaging (mpMRI) has not

yet been established in BC diagnosis and staging. A standardised methodology of

MRI reporting in patients with BC has recently been published and requires validation

[10,11,12].

The mpMRI of the bladder, which refers to a combination of T2-weighted imaging,

diffusion-weighted imaging, and DCE sequences, is used in the scoring of the recently

proposed Vesical Imaging-Reporting and Data System (VI-RADS). To improve

acquisition and interpretation of bladder MRI, the VI-RADS was developed in 2018

by a panel of expert multidisciplinary team members [12,18]. According to the VI-

RADS system, each of the three sequences (T2WI, DWI, and DCE) is scored on a 5-

point scale, which are then combined to derive an overall VI-RADS score classifying

the likelihood of MIBC into five categories. Typically, an overall VI-RADS score 1–2

means MIBC is unlikely, as opposed to a score of 4–5, indicating that MIBC is likely

[12]. To date, four retrospective and one prospective study have validated the VI-

RADS scoring system, demonstrating good performance for identifying MIBC. It is

important to declare a five-point scoring system that can predict muscle-invasive

tumors in the pre-transurethral resection setting. Tumors smaller than 1 cm are highly

unlikely to involve muscle invasion and are assigned VI-RADS 1. Tumors larger than

1 cm are assigned VI-RADS 2. Tumors with a high possibility of muscle invasion or

perivesical tumor extension are assigned VI-RADS 4 or 5. A recent study that

validated the VI-RADS also reported that VI-RADS scores of 4 or 5 were 100%

accurate for predicting muscle invasion. VI-RADS 3 is assigned to cases with an

equivocal likelihood of muscle invasion. Muscle invasion was reportedly present in

two-thirds of patients assigned VI-RADS 3. Although a few studies have validated the

13
VI-RADS, this suggests that it is not easy to determine the invasion depth of tumors

assigned VI-RADS 3[12,17,18,20,21,22,23,24].

A retrospective study of 74 consecutive patients by Takeuchi et al showed a high

degree of inter-observer agreement while using the VI-RADS score to diagnose and

stage BC [23].

A retrospective study by Wang et al reviewed 340 patients with known bladder cancer

with mpMRI and categorized them under VI-RADS. The VI-RADS score was

compared with postoperative pathology for each tumor. Both the VI-RADS score and

its components were associated with muscle-invasive condition (P < .001). Fifty-six

of the 340 tumors were assigned a VI-RADS score of 4 or 5; all 56 had muscle-

invasive disease. Conversely, none of the 29 tumors given a VI-RADS score of 1 had

muscle-invasive disease. Fewer than 5% (11 of 228) of tumors assigned a VI-RADS

score of 2 had muscle-invasive disease. Although fewer than 10% of tumors (27 of

340) were given a VI-RADS score of 3, performance in this group was less accurate,

with two-thirds classified as muscle-invasive disease, and therefore was of limited

utility to accurately predict stage. The sensitivity and specificity of a VI-RADS score

of 3 or greater were 87.1% (95% CI: 78%, 93%) and 96.5% (95% CI: 93%, 98%),

respectively. They concluded that the VI-RADS score effectively defines the

likelihood of detrusor muscle invasion in bladder cancer and should be considered for

evaluation of tumors prior to surgery [21].

A total of 231 patients were enrolled in a prospective study by Del Giudice et al.
Multiparametric MRI showed sensitivity, specificity, PPV, and NPV for
discriminating NMIBC from MIBC at initial TURBT of 91.9% (95% confidence
interval [CI]: 82.2-97.3), 91.1% (95% CI: 85.8-94.9), 77.5% (95% CI: 65.8-86.7), and
97.1% (95% CI: 93.3-99.1), respectively. Among HR-NMIBC patients (n=114),
mpMRI before TURBT showed sensitivity, specificity, PPV, and NPV of 85% (95%

14
CI: 62.1-96.8), 93.6% (95% CI: 86.6-97.6), 74.5% (95% CI: 52.4-90.1), and 96.6%
(95% CI: 90.5-99.3) respectively, to identify patients with MIBC at Re-TURBT [20].
In a retrospective study by Makboul et al, diagnostic accuracy of VI-RADS score in
detection of muscle invasion was 84%, with a specificity and negative predictive
value of 88% [25].
In a review by Carando et al, the sensitivity, specificity, positive (PPV) and negative
predictive value (NPV) were 78-91.9%, 85-91%.1, 69-78%, and 88-97.1%,
respectively. They concluded that the VI-RADS score, using mpMRI, showed
excellent results in discriminating MIBC from NMIBC, but the data needed further
validation [24].
Although cystoscopy is the gold standard for post-treatment follow-up, noninvasive
methods, especially mpMRI, should be used. In addition, simultaneous or alternative
follow-up with CT may be helpful for the identification of upper urinary tract
recurrence or distant metastases [26]. However, patients who undergo post-treatment
surveillance for bladder cancer often have reduced renal function, thus the repetitive
use of MRI or CT contrast agents can be burdensome [27]. In patients with impaired
renal function, biparametric MRI, which does not involve contrast administration, is
expected to aid in the diagnosis and staging of local recurrence [28}.

Thus, we see that while mpMRI and VI-RADS are highly promising advances and
tools in the fight against bladder cancer, for primary diagnosis, staging, as well as in
follow-up, they have not been extensively validated with large-scale studies, with
many studies done for validation being retrospective in nature, and so subject to
inherent bias. Furthermore, there are none in the Indian clinical scenario. There is a
need for further data regarding mpMRI and the VI-RADS, and this study is intended
to fulfil that lacuna.

CONFLICT OF INTEREST:

There is no conflict of interest to declare.

15
SIGNATURE OF CANDIDATE:

(Dr. Kunjan Kumar, M.Ch. Urology Resident, R.G. Kar Medical College & Hospital)

SIGNATURE OF SUPERVISOR:

(Dr. Ranjan K. Dey, Professor, Dept. of Urology, R.G. Kar Medical College &

Hospital)

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2. Saginala K, Barsouk A, Aluru JS, Rawla P, Padala SA, Barsouk A. Epidemiology

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3. Verma S, Rajesh A, Prasad SR, et al. Urinary bladder cancer: Role of MR

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4. Babjuk M, Böhle A, Burger M, et al. EAU guidelines on non-muscleinvasive

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L, et al. Predicting recurrence and progression in individual patients with stage Ta

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from seven EORTC trials. Eur Urol. 2006;49:466–5. discussion 75-7.

6. Gupta P, Jain M, Kapoor R, Muruganandham K, Srivastava A, Mandhani A.

Impact of age and gender on the clinicopathological characteristics of bladder

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7. Soloway MS, Sofer M, Vaidya A. Contemporary management of stage T1

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8. Zapatero A, Martin de Vidales C, Arellano R et al. . Updated results of bladder-

sparing trimodality approach for invasive bladder cancer. Urol

Oncol 2010;28:368–374.

9. Smith ZL, Christodouleas JP, Keefe SM, Malkowicz SB, Guzzo TJ. Bladder

preservation in the treatment of muscle-invasive bladder cancer (MIBC): a review

of the literature and a practical approach to therapy. BJU Int. 2013 Jul;112(1):13-

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Lecomte, A.H. Mostafid, J. Palou, B.W.G. van Rhijn, M. Rouprêt, S.F. Shariat, R.

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 Sylvester EAU Guidelines for Non-muscle invasive bladder cancer. Edn.

presented at the EAU Annual Congress Milan 2021. ISBN 978-94-92671-13-4.

11. M. Babjuk, M. Burger, E. Compérat, P. Gontero, F. Liedberg, A. Masson-

Lecomte, A.H. Mostafid, J. Palou, B.W.G. van Rhijn, M. Rouprêt, S.F. Shariat, R.

Sylvester EAU Guidelines for muscle invasive bladder cancer. Edn. presented at

the EAU Annual Congress Milan 2021. ISBN 978-94-92671-13-4.

12. Panebianco V, Narumi Y, Altun E, et al. Multiparametric magnetic resonance

imaging for bladder cancer: Development of VI-RADS (vesical imaging-reporting

and data system). Eur Urol 2018;74:294-306.

13. Ficarra V, Dalpiaz O, Alrabi N, Novara G, Galfano A, Artibani W. Correlation

between clinical and pathological staging in a series of radical cystectomies for

bladder carcinoma. BJU Int 2005;95:786-790.

14. Huang L, Kong Q, Liu Z, Wang J, Kang Z, Zhu Y. The diagnostic value of MR

imaging in differentiating t staging of bladder cancer: A metaanalysis. Radiology

2018;286:502-511.

15. Gandhi N, Krishna S, Booth CM, et al. Diagnostic accuracy of magnetic

resonance imaging for tumor staging of bladder cancer: Systematic review and

meta-analysis. BJU Int 2018;122:744-753.

16. Woo S, Suh CH, Kim SY, Cho JY, Kim SH. Diagnostic performance of MRI for

prediction of muscle-invasiveness of bladder cancer: A systematic review and

meta-analysis. Eur J Radiol 2017;95:46-55.

17. Woo S, Suh CH, Kim SY, Cho JY, Kim SH. The diagnostic performance of MRI

for detection of lymph node metastasis in bladder and prostate cancer: An updated

systematic review and diagnostic meta-analysis. Am J Roentgenol 2018;210:W95-

W109.

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18. Panebianco V, Narumi Y, Altun E, et al. Multiparametric magnetic resonance

imaging for bladder cancer: Development of VI-RADS (vesical imaging-reporting

and data system). Eur Urol 2018;74:294-306.

19. Sim KC, Sung DJ. Role of magnetic resonance imaging in tumor staging and

follow-up for bladder cancer. Transl Androl Urol. 2020;9(6):2890-2907

20. Del Giudice F, Barchetti G, De Berardinis E, et al. Prospective assessment of

vesical imaging reporting and data system (VI-RADS) and its clinical impact on

the management of high-risk non–muscle-invasive bladder cancer patients

candidate for repeated transurethral resection. Eur Urol 2020;77:101-109.

21. Wang H, Luo C, Zhang F, et al. Multiparametric MRI for bladder cancer:

Validation of VI-RADS for the detection of detrusor muscle invasion. Radiology

2019;291:668-674.

22. Kim SH. Validation of vesical imaging reporting and data system for assessing

muscle invasion in bladder tumor. Abdom Radiol 2019;45 (2):491-498.

23. Ueno Y, Takeuchi M, Tamada T, et al. Diagnostic accuracy and interobserver

agreement for the vesical imaging-reporting and data system for muscle-invasive

bladder cancer: A multireader validation study. Eur Urol 2019;76:54-56.

24. Carando R, Afferi L, Marra G, Krajewski W, Pagliarulo V, Abufaraj M, Xylinas

E, Cathelineau X, Sanchez-Salas R, Moschini M. The effectiveness of

multiparametric magnetic resonance imaging in bladder cancer (Vesical Imaging-

Reporting and Data System): A systematic review. Arab J Urol. 2020 Mar

1;18(2):67-71.

25. Makboul M, Farghaly S, Abdelkawi IF. Multiparametric MRI in differentiation

between muscle invasive and non-muscle invasive urinary bladder cancer with

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 vesical imaging reporting and data system (VI-RADS) application. Br J Radiol.

2019 Dec;92(1104):20190401.

26. Sim KC, Sung DJ. Role of magnetic resonance imaging in tumor staging and

follow-up for bladder cancer. Transl Androl Urol. 2020;9(6):2890-2907.

27.  Lee CH, Tan CH, Faria SC, et al. Role of Imaging in the Local Staging of

Urothelial Carcinoma of the Bladder. Am J Roentgenol 2017;208:1193-205.

28. Johnson RJ, Carrington BM, Jenkins J, et al. Accuracy in staging carcinoma of the

bladder by magnetic resonance imaging. Clin Radiol 1990;41:258-63.

PATIENT CONSENT FORM

Name of the study:

I, Mr./Mrs./ Ms/ Master…………………………………………………….

S/o, D/o, W/o……………………………………………………….

Resident of………………………………………………………….

Aged …….. years, do hereby declare that I have been fully informed about all aspects of the
study, including the procedures and possible complications.

My participation in this study is not obligatory and I can opt out from the study at any point
of time. In that case, I shall not have to show any cause or it will not hamper my treatment or
other aspects. My name, particulars and the data collected will be kept concealed, but the
investigator or ethical committee can observe my treatment records for the study and its
future aspects. The data and the results can be used in this study. Knowing all the above
aspects I give my full informed voluntary consent to participate in this study.

20
I have also been informed to contact Dr. Kunjan Kumar (Dept. of Urology) in case of any
emergency arising during the course of study.

Name of the declarant/Guardian……………………………

Signature/left thumb impression…………………………………………

Dated………………………………………………………………………

Name of the investigating officer………………………………................

Signature…………………………………………………………………..

रोगी सहमति फॉर्म

अध्ययन का नाम: :

मैं, श्री / श्रीमती / सुश्री / मास्टर .............................................................

एस / ओ / डी ओ, w / ओ ................................................................

के निवासी ...................................................................

आयु वर्ग के ........, घोषणा करता हूं कि मैं प्रक्रिया और संभावित जटिलताओं सहित पूरी
तरह से अध्ययन के सभी पहलुओं के बारे में सूचित किया गया है .

इस अध्ययन में मेरी भागीदारी अनिवार्य नहीं है और मैं समय के किसी भी बिंद ु पर
अध्ययन से बाहर विकल्प चुन सकते हैं. उस मामले में , मैं किसी भी कारण दिखाने या यह
मेरे उपचार या अन्य पहलओ
ु ं में बाधा नहीं होगा. मेरा नाम, विवरण और एकत्र डेटा रखा
जा छुपा होगा, लेकिन अन्वेषक या नैतिक समिति के अध्ययन और उसके भविष्य के
पहलओ
ु ं के लिए मेरे उपचार के रिकॉर्ड का निरीक्षण कर सकते हैं. डेटा और परिणाम इस
अध्ययन में इस्तेमाल किया जा सकता है . सभी उपरोक्त पहलओ
ु ं जानके मैं स्वैच्छिक
इस अध्ययन में भाग लेने के लिए सहमति दे ता हूं.

21
 मैं अध्ययन के दौरान उत्पन्न होने वाली किसी भी आपात स्थिति के मामले में डॉ.
Kunjan Kumar (Urology विभाग) से संपर्क किया जा सकता है .

घोषक / अभिभावक का नाम .................................

हस्ताक्षर / बाएं अंगूठे की छाप ................................................, दिनांक .............................

जांच अधिकारी का नाम....................................................

हस्ताक्षर .............................................................................

রুগির সম্মতি পত্র

বিষয়: মূত্রনালির রোগ গ্রস্ত হয়ে যাওয়া সরু অংশের অস্ত্রোপচারের ফলে যৌন জীবনে পরিবর্ত ন নিয়ে
গবেষণা ।

আমি শ্রী..................…..............

পিতা.......................................

ঠিকানা...................…...............

বয়স...............

ঘোষণা করছি যে এই গবেষণার সমস্তকিছু আমি অবগত,অস্ত্রোপচার এর ধরণ ও সম্ভব্য জটিলতা সমন্ধে আমি
অবগত।

এই গবেষণায় অংশগ্রহণে আমি বাধ্য নোই এবং যেকোনো মুহূর্তে গবেষণা থেকে সরে যাওয়ার সম্পুর্ন স্বাধীনতা
আমার আছে।সেক্ষেত্রে আমাকে কোনও কারণ দেখাতে হবেনা বা তার জন্য আমার চিকিৎসায় কোনোরূপ বিঘ্নতা
আসবেনা।আমার নাম ,বিবরণ এবং আমার যাবতীয় তথ্য অপ্রকাশ্যে থাকবে কিন্তু গবেষক বা নিয়ামক মন্ডলী
আমার তথ্য বা চিকিৎসা বিবরণী গবেষণার স্বার্থে ভবিষ্যতে পর্যালোচনা করতে পারেন।সেই তথ্য এবং চিকিৎসার
ফলাফল নাম অপ্রকাশিত রেখে গবেষণার কাজে ব্যবহার করা যেতে পারে।সব কিছু জেনে আমি সেচ্ছায় এই
গবেষণায় অংশ নেওয়ার সম্মতি দিলাম।

আমাকে আরও জানানো হল গবেষণা কালে কোনও জরুরি প্রয়োজনে আমি ডা: ………………………………… (ইউরোলজি
বিভাগ) এর সাথে যোগাযোগ করতে পারি।

ঘোষণা কারীর নাম.......................

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সই/বাম বৃদ্ধাঙ্গুস্থির ছাপ....................

তারিখ.........................

গবেষক এর নাম......................

গবেষক এর সই.........................

Data Collection Sheet

 Name of the patient:

 Age:

 Sex:

 Address:

 Registration No:

 Radiological Assessment of Bladder Tumour:

 VI-RADS score

 Investigations:

1. Complete Hemogram:

2. Blood Sugar (FBS & PPBS):

3. Urea and Creatinine:

4. Serum electrolytes:

5. USG of KUB:

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6. CT KUB:

7. Complete Urine Analysis and Urine C/S:

8. HPE Report Analysis

 If BCG taken(yes/no) –
 If yes, details –

 Recurrence period (if occurred) -

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