ABHILASH PROTOCOL

1. EVALUATION OF MALE URETHRAL STRICTURES USING
SONOURETHROGRAPHY – COMPARITIVE STUDY WITH
CONVENTIONAL RETROGRADE URETHROGRAPHY
DR. ABHILASH PEDDU
REG. NO: 1601201003 | JUNE / 2016| APRIL / 2019
COURSE OF STUDY ( M.D RADIOLOGY ), MGMCRI
GUIDE
DR. B R NAGARAJ
(PROFESSOR & HEAD)
DEPARTMENT OF RADIOLOGY , MGMCRI
Co-GUIDE
DR. ARMEL ARPUTHA SIVARAJAN
( ASSISTANT PROFESSOR)
DEPARTMENT OF RADIOLOGY , MGMCRI
MAHATMA GANDHI MEDICAL COLLEGE & RESEARCH INSTITUTE

2. CANDIDATE
* Candidate Name : ABHILASH PEDDU
* Course of Study : MD RADIOLOGY
* University Identity No : 1601201003
* Mobile Phone No : +91 8008012689
* E-mail Address : abhilash3000ad@gmail.com
* Month/Yr of Admission : JUNE 2016
* Month/Yr of Examination : APRIL 2019
GUIDES
* GUIDE: DR. B.R.NAGARAJ , M.D.R.D , D.M.R.D , FICR.
* Professor and Head of the Department
* Department of Radiology
* Contact Number : +91-413-2615449
* Email – radiology@mgmcri.ac.in
* CO GUIDE: DR. ARMEL ARPUTHA SIVARAJAN , M.D.
* Assistant Professor
* Department of Specialty
* Contact Number : +91-99430 22775
* Email - armelsiva@gmail.com
PART II – THE PROTOCOL
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3. 1. INTRODUCTION
Urethral pathologies, especially strictures are common problem affecting
young adult males and are a major cause of morbidity and discomfort. However,
imaging has an important role to play in the study of the stricture diseases of the
male urethra since it can detect pathology not visible on urethroscopy.
Retrograde urethrography (RGU) is the standard imaging study for the
evaluation of anterior male urethra.
Originally, RGU was performed using penile clamps and other devices.
McCallum popularized use of Foley’s catheter in the distal urethra to help retain
contrast material after filling.
Diagnostic imaging of the male urethra has depended on these techniques,
which involve the use of radiation and intra-urethral injection of contrast medium to
visualize luminal anatomy. Limitations of RGU in accurate evaluation of anterior
urethral stricture diseases include variation in the appearance of strictures with
position of the patient and the degree of stretch of the penis during the study. It also
provides limited information about periurethral structures.
In 1988 McAninch et al. reported a new technique for imaging the male
anterior urethra with high-resolution ultrasound (sonourethrography). The initial
technique involved the use of a 5 MHz linear array transducer applied to the dorsal
surface of the penis. Images were obtained during retrograde instillation of normal
saline. As the normal urethral wall and spongiosum are elastic they are compressible
on saline injection. When altered by stricture disease the corpus spongiosum loses its
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4. elasticity due to higher collagen content and is not compressible, causing a reduction
in the inner diameter of the urethra.
An ideal study should be able to indicate the type of surgical procedure
suitable for the patient. This includes accurate determination of the site, length and
diameter of strictures. Complete preoperative knowledge of complicating conditions
like urethral calculi, fistulae, false tracts, diverticula and polyps facilitate favorable
urethroplasty outcomes.
As a dynamic, three-dimensional study, which can be repeated without
radiation exposure, sonourethrography (SUG) offers important technical advantages
compared with RGU. This study was undertaken to explore the ultrasound in
evaluating stricture disease of the male anterior urethra and comparing it with RGU.
2. AIMS AND OBJECTIVES
1. AIM - This study is undertaken to explore the uses of sonourethrography with
high-resolution ultrasound in evaluating stricture disease of the male urethra
and comparing it with retrograde urethrography.
2. Objectives - To see how efficacious sonouethrography in evaluating male
urethral strictures compared with retrograde urethrography.
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5. 3. REVIEW OF LITERATURE
Talreja SM et al.; conducted a study on comparison of sonoelastography with
sonourethrography and retrograde urethrography in the evaluation of male anterior
urethral strictures and gave result as overall diagnostic accuracy of SE, SUG, and
RGU for the estimation of stricture location, and length were estimated 92.68% vs.
91.54%, 79% vs. 78.87% and 80.48% vs. 43.66%, respectively, while for depth of
spongiofibrosis SE, and SUG had accuracy rates of 87.3%, 48%, respectively. The
mean length measured on SE was nearest to the mean intra-operative stricture length
(21.34+11.8 mm). SE findings significantly correlated with the colour of bladder
mucosa on cystoscopic examination (p=0.003) whereas the association was non-
significant (p=0.127) for difficulty in incision. While a nonsignificant correlation
existed between SUG findings related both to the colour of the bladder mucosa and
difficulty in incision on cystoscopy, SE findings had a significant association
(p<0.001) with histopathology findings for severe degree of fibrosis.
They came to a conclusion sonoelastography estimates stricture site and
length better in comparison with RUG and SUG. It estimates degree of
spongiofibrosis which serves as an important prognostic factor for stricture
recurrence more accurately than SUG.
Maciejewski C et al.; researched on urethral strictures and concluded accurate
imaging of urethral strictures is critical for preoperative staging and planning of
reconstruction. The current gold standard, retrograde urethrography (RUG), allows
for accurate diagnosis, staging, and delineation of urethral strictures, and remains a
cornerstone in the management of urethral stricture disease. In complex situations,
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6. the RUG can be combined with voiding cystourethrogram (VCUG) in order to better
visualize the posterior urethra or complex distraction defects. Direct visualization of
the stricture by cystoscopy, either retrograde or antegrade, can provide additional
information as to the location and appearance of stricture, as well as precise location
on fluoroscopic imaging. Sonourethrography (SU) is a useful adjunct to allow for
three-dimensional assessment of stricture length and location, and can be a useful
intraoperative assessment tool, however, its use remains limited to a second-line
setting. Cross-sectional imaging in the form of computed tomography (CT) or
magnetic resonance urethrography can provide additional three-dimensional
information of anatomic structures and their relations, and can serve as a useful
adjunct in complex clinical scenarios.
Ani C et al.; conducted a study has demonstrated that sonourethrography is a
valuable diagnostic tool in the evaluation of anterior urethral stricture. The
management of urethral stricture is a challenge to both the urologists and the
patients. Thoughtful and satisfactory preoperative evaluation remains important to
achieving good outcome. Retrograde urethrography and Micturating
Cystourethrography (RUG/MCUG) have been the gold standard imaging technique
in the evaluation of anterior urethral stricture but are not without inherent limitations
and side effects. Sonourethrography (SUG) could diagnose anterior urethral stricture,
measure its length, and detect presence of complications and extent of
spongiofibrosis.
Akano AO et al.; did a research on the same topic as ours and concluded
Ultrasound is as efficacious as retrograde urethrogram in the assessment of the male
anterior urethra in patients with urethral stricture and may be recommended in the
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7. evaluation of this disease, in view of its efficacy, non-invasiveness, ready-availability
and lack of exposure to radiation. It may also serve as baseline for other similar
studies in our environment.
Mitterberger M et al.; did a study on Gray scale and color Doppler
sonography with extended field of view technique for the diagnostic evaluation of
anterior urethral strictures and gave result as Gray scale and color Doppler
sonourethrography using the extended field of view technique with a Siemens
Sonoline Elegra is a promising tool for defining male urethral strictures. It seems to
be superior to radio urethrography for treatment planning.
Arda K et al.; conduced a study on Twenty-three male patients with known or
suspected urethral stricture disease who were evaluated using sonourethrography and
standard retrograde x-ray urethrography for comparative analysis of two techniques.
Results were evaluated statistically. These two methods can substitute each other in
determining the stricture area length of anterior urethra. Due to advantages, if both of
these methods are used combining each other, we believe that they will be much
more sensitive.
Gupta S et al; conducted a study on 30 patients with suspected urethral
strictures underwent sonographic and roentgenographic urethrograms. Two patients
showed a normal anterior urethra in the sonourethrogram; 29 strictures were
diagnosed in the remaining 28 patients, 1 patient showing strictures at two different
sites. Sonourethrography was an accurate predictor of stricture length, retrograde
urethrography underestimating the stricture length in most of the cases. Periurethral
structures, including the urethral wall, corpus spongiosum, corpora cavernosa, bulb,
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8. and external urinary sphincter, were seen clearly with sonourethrography.
Periurethral fibrosis was seen in 16 patients and graded as mild (n = 5), moderate (n
= 2) or severe (n = 9), depending on the depth of involvement of the corpus
spongiosum. Sonourethrography was unsatisfactory in the evaluation of membranous
strictures, failing to visualize the proximal limit of the stricture.
4. RESEARCH QUESTION OR HYPOTHESIS
HOW EFFICACIOUS IS SONOUETHROGRAPHY IN
EVALUATING MALE URETHRAL STRICTURES WHEN
COMPARED WITH RETROGRADE URETHROGRAPHY ?
5. SUBJECTS AND METHODS
5.1 STUDY SUBJECTS
The Study Involves HUMANS.
5.2 TYPE OF STUDY
This is a cross sectional, comparative study design with prospective
recruitment of patients.
5.3 PLACE OF STUDY
This comparative study is done at Department of Radiology MGMCRI , Puducherry.
5.4 SELECTION PROCESS
STUDY POPULATION
All male patients referred from Department of Urology and Department of
Radiology for Urethral Stricture Evaluation at MGMCRI.
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9. 5.5 INCLUSION CRITERIA
• All age groups of males with urethral strictures.
5.6 EXCLUSION CRITERIA
Females are excluded in this study.
Male patients with symptoms suggestive of acute urethritis are excluded.
5.7 SAMPLING PROCEDURE
Continuous sampling until sample size is achieved.
5.8 STUDY GROUPS
The study includes only 1 group.
5.9 SAMPLE SIZE
Sample Size is 40.
6 METHODOLOGY / PROCEDURES:
40 male patients with urethral strictures are included in this study. Imaging
of the urethral stricture is done using retrograde urethrography and then a follow up
sonourethrography .
Data collected from imaging is studied and compared for evaluating the
efficacy of the procedures for urethral strictures .
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10. 7. INTERVENTIONS/DRUGS USE
BOTH RETROGRADE URETHROGRAM AND SONOURETHROGRAM
ARE INTERVENTIONAL PROCEDURES.
Retro-Urethrogram
Sonourethrogram - it is also performed as RGU but, instead of a contrast we inject
normal saline into the male urethra and then studied on real time ultrasonography for
evaluation of strictures.
Procurement of Investigational Drugs, Storage, Dispensing, etc.
NIL
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PREPARE EXTERNAL MEATUS IN STERILE
FASHION .
PREPARE EXTERNAL MEATUS IN STERILE
FASHION .
UNDER ASEPTIC CONDITONS , CATHETERISE
THE URINARY BLADDER WITH THE PATIENT IN
SUPINE POSITION .
UNDER ASEPTIC CONDITONS , CATHETERISE
THE URINARY BLADDER WITH THE PATIENT IN
SUPINE POSITION .
PUSH THE DILUTED CONTRAST MEDIUM
(OMNIPAQUE) SLOWLY UNDER FLUROSCOPIC
GUIDANCE .
PUSH THE DILUTED CONTRAST MEDIUM
(OMNIPAQUE) SLOWLY UNDER FLUROSCOPIC
GUIDANCE .
ASK THE PATIENT TO MICTURATE IN A URINE
RECEIVER IN AN ERECT OBLIQUE POSITION .
ASK THE PATIENT TO MICTURATE IN A URINE
RECEIVER IN AN ERECT OBLIQUE POSITION .
SPOT IMAGES ARE TAKEN DURING
MICTURATION IN THE RIGHT AND LEFT
OBLIQUE PROJECTIONS AND ANY REFLUX IS
RECORDED .
SPOT IMAGES ARE TAKEN DURING
MICTURATION IN THE RIGHT AND LEFT
OBLIQUE PROJECTIONS AND ANY REFLUX IS
RECORDED .
THE IMAGES OBTAINED ARE USED FOR
EVALUATION OF URETRAL STRICTURES .
THE IMAGES OBTAINED ARE USED FOR
EVALUATION OF URETRAL STRICTURES .

11. 8. STUDY TERMINATION
After achieving the sample size.
9. STUDY VARIABLES
Please edit to enter the Study Outcomes/Variables and Parameters your project will
monitor, measure and record.
Distinguish between:
1. Dependent Variable (Outcome Variables)
2. Independent Variables (Variables that influence the
outcome/demographic/socio-economic variables being planned to be
observed in the study)
S. No
Name of the
dependent /
independent variables
Scale of measurement
(Quantitative /
qualitative)
Descriptive /
Inferential Statistics
to be used
1. Stricture morphology
on RGU
Quantitative Correlation
2 Stricture morphology
on SUG
Quantitative Correlation
10. DATA COLLECTION
Data will be collected using predefined data capture form / schedule /
questionnaire. Secondary Data will be collected from hospital records. Privacy and
Confidentiality to be maintained. All patient identifiable numbers and information
should be stripped and replaced by anonymous numbers.
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12. 11. STATISTICAL METHODS
The sensitivity, specificity, positive and negative predictive value of all parameters
are calculated. The strength of agreement between RGU and sonourethrography are
calculated using kappa statistics, whereby a kappa value of, 0.2 indicated a poor
agreement, 0.21-0.40 indicated a fair agreement; 0.41-0.60, moderate agreement;
0.61-0.80, good agreement; 0.81-1.00, very good agreement.
12. REFERENCES
1. Turk J Urol. 2016 Jun;42(2):84-91. doi: 10.5152/tud.2016.99223. Comparison of
sonoelastography with sonourethrography and retrograde urethrography in the
evaluation of male anterior urethral strictures. Talreja SM, Tomar V, Yadav SS, Jaipal U,
Priyadarshi S, Agarwal N, Vyas N.
2. Transl Androl Urol. 2015 Feb;4(1):2-9. doi: 10.3978/j.issn.2223-4683.2015.02.03.
Imaging of urethral stricture disease. Maciejewski C, Rourke K. Author information:
Division of Urology, Department of Surgery, University of Alberta, Edmonton, Alberta,
Canada.
3. J West Afr Coll Surg. 2012 Jan;2(1):1-13. Sonourethrography in the evaluation of anterior
urethral stricture. Ani C, Akpayak I, Dakum N, Ramyil V, Shuaibu S. Author information:
Department of Radiology, Jos University Teaching Hospital, Jos. Urology Division,
Department of Surgery, Jos University Teaching Hospital, Jos, Nigeria.
4. West Afr J Med. 2007 Apr-Jun;26(2):102-5. Evaluation of male anterior urethral strictures
by ultrasonography compared with retrograde urethrography. Akano AO. Author
information: Department of Radiology, National Hospital, Abuja.
aakano2002@yahoo.com.
5. J Urol. 2007 Mar;177(3):992-6; discussion 997. Gray scale and color Doppler
sonography with extended field of view technique forthe diagnostic evaluation of anterior
urethral strictures. Mitterberger M, Christian G, Pinggera GM, Bartsch G, Strasser H,
Pallwein L, Frauscher F. Author information: Department of Urology, Medical University
Innsbruck, Innsbruck, Austria. michael.mitterberger@uibk.ac.at.
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13. 6. Arch Ital Urol Androl. 1995 Sep;67(4):249-54. Sonourethrography in anterior urethral
stricture: comparison to radiographic urethrography. Arda K(1), Basar M, Deniz E, Yildiz
S, Akpìnar L, Olçer T. Author information: Türkiye Yüksek Ihtisas Hospital, Department
of Radiology, Ankara, Turkey.
7. J Clin Ultrasound. 1993 May;21(4):231-9. Sonourethrography in the evaluation of anterior
urethral strictures: correlation with radiographic urethrography. Gupta S(1), Majumdar B,
Tiwari A, Gupta RK, Kumar A, Gujral RB. Author information: Department of
Radiodiagnosis, Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow,
India.
8. A Comparative Study of Sonourethrography and Retrograde Urethrography in Evaluation
of Anterior Male Urethral Strictures Anand Hatgaonkar MD (Radiodiagnosis), Assistant
Professor in the Department of Radiodiagnosis, Government Medical College, Nagpur,
Maharashtra, India.
9. Dr. Anand Hatgaonkar, c/o P.B. Salpekar, 136, Dronacharya Nagar, Trimurti Nagar,
Nagpur - 440022.
13. PRELIMINARY WORK DONE ALREADY
Appropriate references has been searched , studied and included.
14. ETHICAL ISSUES
The Study Involves Issue No:
- Young Patients under the age of 18.
- Patients of Geriatric Age group.
- Ionising radiation like X-rays.
- Intervention procedure in the therapy.
Note: In India, ‘majority’ is achieved at an age of 18 years and considered a legal age
for giving a valid consent for treatment as per Indian Majority Act, Guardian and
Wards Act, and Indian Contract Act. A child below 12 years (minor) cannot give
consent, and parents/guardian can consent for their medical/surgical procedures. A
child between 12-18 years can give consent only for medical examination but not for
any procedure.
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14. If you have any subject below the age of 18 or unable to give fully informed
independent consent, give details below:
15. QUALITY CONTROL
Name of Officer designated by the department for quality control:
Name : Dr. B.R.Nagaraj
Designation: Head of the Department
Telephone No: +91-413-2615449
E-mail: radiology@mgmcri.ac.in dr.br.nagaraj@gmail.com
16. SPONSORSHIPS
NONE
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15. 17. INVESTIGATORS DECLARATION
This is to certify that the protocol entitled “EVALUATION OF MALE
URETHRAL STRICTURES USING SONOURETHROGRAPHY –
COMPARITIVE STUDY WITH CONVENTIONAL RETROGRADE
URETHROGRAPHY” was reviewed by us for submission to the SBV Institutional
Ethics Committee and certified that this protocol represents an accurate and complete
description of the proposed research. We have read the ICMR guidelines, ICP-GCP
guidelines/CPCSEA guidelines/and other applicable guidelines and undertake to
ensure that the rights and welfare of the study subjects are protected.
The study will be performed as per the approved protocol only. If any deviation is
warranted, the same will be presented to the ethical committee and permission will
be sought. We assure that the study will be terminated immediately in case of any
unforeseen adverse consequences and we will inform the same to the ethical
committee immediately.
Dr. B.R.NAGARAJ
Professor and Head of Department
Department of RADIO DIAGNOSIS
Guide
Dr. A.A. SIVARAJAN
Assistant Professor
Department of RADIO DIAGNOSIS
Co-guide
Dr. ABHILASH PEDDU
Candidate MD (RADIO DIAGNOSIS)
Dr. B.R.NAGARAJ
Head of Department of RADIO DIAGNOSIS
with Dept. Seal
15

16. 18. INFORMED CONSENT PROCEDURE
INFORMATION SHEET FOR THOSE WHO PLAN TO PARTICIPATE IN
THE RESEARCH PROJECT
NAME OF THE RESEARCH PROJECT: EVALUATION OF MALE
URETHRAL STRICTURES USING SONOURETHROGRAPHY –
COMPARITIVE STUDY WITH CONVENTIONAL RETROGRADE
URETHROGRAPHY
We welcome you and thank you for having accepted our request to
consider whether you can participate in our study. this sheet contains the
details of the study; the possible risks, discomfort and benefit for the
participants are also given.
You can read and understand by yourself; if you wish, we are ready to read and
explain the same to you.
If you do not understand anything or if you want any more details we are ready to
provide the details.
Information to the participants:
What is the purpose of the study?
To check the efficacy of SUG comparing with RGU for evaluating urethral
strictures in males .
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17. Who / where this study is being conducted?
This study is being conducted by Dr. ABHILASH PEDDU a Post-Graduate
medical student belonging to Mahatma Gandhi Medical College and Research
Institute, Radiology department under the guidance of Dr. B.R NAGARAJ.
Why I am being considered as one of the participant?
Since you are diagnosed with urethral stricture.
Should I definitely have to take part in this study?
No. If you do not wish to participate you will not be included in this study.
Also you will continue to get the medical treatment without any prejudice.
If I am participating in this study, what are my responsibilities?
No additional responsibilities apart from them required from routine
management.
Are there any benefits for me / public?
The results of this study can help in the management of healthy fetal out
come to decrease fetal morbidity.
Will there be any discomfort / risks to me?
No risks. But frequent visits to the hospital for undergoing scheduled
antenatal scans will be needed.
Will I be paid for the study?
No. You will not be paid.
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18. Will my participating in this study, my personal details will be kept
confidentially?
Yes, confidentiality will be maintained.
Will I be informed of this study’s results and findings?
Yes, if you want you can get the details from us.
Can I withdraw from this study at any time during the study period?
Yes. You can withdraw at any time during the study period.
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19. VOLUNTEERS RECRUITEMENT PROCESS
FORM FOR OBTAINING INFORMED CONSENT
FROM THE PARTICIPANTS OF THE
RESEARCH PROJECT
EVALUATION OF MALE URETHRAL STRICTURES USING
SONOURETHROGRAPHY – COMPARITIVE STUDY WITH
CONVENTIONAL RETROGRADE URETHROGRAPHY
I, _____________________ HAVE BEEN INFORMED ABOUT THE
DETAILS OF THE STUDY IN MY OWN LANGUAGE.
I have completely understood the details of the study.
I am aware of the possible risks and benefits, while taking part in the study.
I understand that I can withdraw from the study at any point of time and even then, I
will continue to receive the medical treatment as usual.
I understand that I will not get any payment for taking part in this study.
I will not object if the results of this study are getting published in any medical
journal, provided my personal identity is not revealed.
I know what I am supposed to do by taking part in this study and I assure that I
would extend my full co-operation for this study.
Signature/Thumb impression of the Volunteer
Date:
Name and Address of the Volunteer:
Witnesses:
(Signature, Name & Address)
Date:
Name & Signature of the Principal Investigator:
Dr. PRINCIPAL INVESTIGATOR
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