COMPARISON BETWEEN VISUAL PROSTATE SYMPTOM SCORE AND FLOW RATE IN BENIGN

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COMPARISON BETWEEN VISUAL PROSTATE SYMPTOM SCORE AND FLOW RATE IN BENIGN

PROSTATIC HYPERPLASIA (BPH):

A CROSS SECTIONAL STUDY

BY

NARAYANAN A/L KATHIRESAN

A dissertation submitted in fulfilment of the requirement for the degree of Master of Surgery (General Surgery)

Kulliyyah of Medicine

International Islamic University Malaysia

NOVEMBER 2018

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ABSTRACT

Objective: To determine the correlation between visual prostate symptom score that is filled up without assistance and uroflowmetry (Qmax) among BPH patients undergoing treatment in Urology Clinic in a tertiary centre in Malaysia. Methodology: Ours is a cross sectional study done in a tertiary hospital in Kuantan, Malaysia.74 adult male patients who is under urology clinic follow up for benign prostatic hyperplasia were recruited and filled up the Visual Prostate Symptom Score sheet without assistance from medical personnel. Results were compared with Qmax values from uroflowmetry which is the routine measurement done in urology clinics to determine correlation with VPSS scores. Results: Pearson correlation was done to compare total VPSS score and Qmax.

Our results show a weak correlation between VPSS total score and Qmax. (r=-0.149, p=0.205) that is not significant. We have done a subgroup analysis on age and education status and results did not correlate for all the subgroups. Conclusion: This study found that VPSS is not suitable to be filled up by patients on their own without medical practitioner assistance. We would recommend VPSS be filled up with assistance.

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APPROVAL PAGE

I certify that I have supervised and read this study and that in my opinion; it conforms to acceptable standards of scholarly presentation and is fully adequate, in scope and quality, as a dissertation for the degree of Master of Surgery (General Surgery).

………..

Mohd Nazli Kamarulzaman Supervisor

………..

Hamid Hj Ghazali Co-Supervisor

I certify that I have read this study and that in my opinion it conforms to acceptable standards of scholarly presentation and is fully adequate, in scope and quality, as a dissertation for the degree of Master of Surgery (General Surgery).

………..

Azmi Md Nor Examiner

This dissertation was submitted to the Department of Surgery and is accepted as a fulfilment of the requirement for the degree of Master of Surgery (General Surgery).

………..

Junaini Kasian

Head, Department of Surgery

This dissertation was submitted to the Kulliyyah of Medicine and is accepted as a fulfilment of the requirement for the degree of Master of Surgery (General Surgery).

………..

Azmi Md Nor

Dean, Kulliyyah of Medicine

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DECLARATION

I hereby declare that this dissertation is the result of my own investigation, except where otherwise stated. I also declare that it has not been previously or concurrently submitted as a whole for any other degrees at IIUM or other institutions.

Narayanan A/L Kathiresan

Signature………....………. Date …….……….

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COPYRIGHT

INTERNATIONAL ISLAMIC UNIVERSITY MALAYSIA

DECLARATION OF COPYRIGHT AND AFFIRMATION OF FAIR USE OF UNPUBLISHED RESEARCH

COMPARISON BETWEEN VISUAL PROSTATE SYMPTOM SCORE AND FLOW RATE IN BENIGN PROSTATIC HYPERPLASIA (BPH): A CROSS SECTIONAL STUDY

I declare that the copyright holder of this dissertation are jointly owned by the student and IIUM.

No part of this unpublished research may be reproduced, stored in a retrieval system, or transmitted, in any form or by any means, electronic, mechanical, photocopying, recording or otherwise without prior written permission of the copyright holder except as provided below

1. Any material contained in or derived from this unpublished research may be used by others in their writing with due acknowledgement.

2. IIUM or its library will have the right to make and transmit copies (print or electronic) for institutional and academic purposes.

3. The IIUM library will have the right to make, store in a retrieved system and supply copies of this unpublished research if requested by other universities and research libraries.

By signing this form, I acknowledged that I have read and understand the IIUM Intellectual Property Right and Commercialization policy.

Affirmed by Narayanan A/L Kathiresan

……..……….. ………..

Signature Date

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DEDICATION

This dissertation is dedicated to my parents, families, colleagues and Urology department of HTAA and IIUM Medical Centre

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ACKNOWLEDGEMENTS

This dissertation was the culmination of two years of planning, research, data collection, analysis and writing. It would not have been possible to complete this dissertation without the help and support of many individuals

I would like to thank the International Islamic University Malaysia (IIUM) for giving me the opportunity to do this research. I would like to thank my supervisor Assoc Prof Dr Mohd Nazli Kamarulzaman and co supervisor Dr Hamid Hj Ghazali. I would like to thank Dr Hamid for giving me this topic and access to the urology clinic in Hospital Tengku Ampuan Afzan for me to complete this project. I would like to thank Assoc Prof Dr Mohd Nazli for his supervision and guidance throughout this research. I would like to thank the Department of General Surgery IIUM, all my professors, consultants, specialists and fellow colleagues for the constant guidance and support throughout this project.

I would like to thank the wonderful staff of Urology Clinic Hospital Tengku Ampuan Afzan for their support and help in conducting my research and ensuring it went smoothly. I would like to thank the Clinical Research Centre (CRC) for their help as well.

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LIST OF TABLES

Table 3.1 Descriptive statistics (n=74) 17

Table 3.2 Correlation between Uroflow Qmax and VPSS score (n=74) 17 Table 3.3 Linear regression between uroflow Qmax and VPSS score

(n=74) 19

Table 3.4 Correlation between Uroflow Qmax and VPSS score according

to age groups 20

Table 3.5 Correlation between Uroflow Qmax and VPSS score according

to education level 25

Table 4.1 Comparison of other studies 34

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LIST OF FIGURES

Figure 2.1 Flowmaster PC based wireless uroflowmetry by Medical

Measurement Systems US 12

Figure 2.2 Sample urinary flow curve with Qmax 13

Figure 2.3 Visual Prostate Sympom score questionaire (Minimum score=3,

Maximum score=23) 14

Figure 3.1 Correlation between VPSS and uroflow Qmax among study subjects (uroflow Qmax= maximum urinary flow rate, VPSS=

visual prostate symptom score). 18

visual prostate symptom score) for age group below 60. 21 Figure 3.3 Correlation between VPSS and uroflow Qmax among study

subjects (uroflow Qmax= maximum urinary flow rate, VPSS=

visual prostate symptom score) for age subgroup 60 to 69 years.

22 Figure 3.4 Correlation between VPSS and uroflow Qmax among study

visual prostate symptom score) for age subgroup 70 to 79 years.

23 Figure 3.5 Correlation between VPSS and uroflow Qmax among study

visual prostate symptom score) for age group 80 and above 24 Figure 3.6 Correlation between VPSS and uroflow Qmax among study

visual prostate symptom score) for no formal education

subgroup. 26

visual prostate symptom score) for primary level education

subgroup. 27

visual prostate symptom score) for secondary level education

subgroup. 28

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visual prostate symptom score) for pre-university level

education subgroup. 29

visual prostate symptom score) for tertiary level education

subgroup. 30

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CHAPTER ONE

INTRODUCTION AND LITERATURE REVIEW

1.1 BENIGN PROSTATIC HYPERPLASIA AND LOWER URINARY TRACT OBSTRUCTION

Benign prostatic hyperplasia (BPH) is an enlargement of the prostate gland. It is due to hyperproliferation of the epithelial cells of the prostate gland. It was found to occur in the transitional zone of the prostate gland by Mcneal et al. They also demonstrated the zonal division of the prostate gland into peripheral, central and transitional zones. The peripheral zone is a frequent site for development of prostatic carcinoma and the transitional or periurethral zone which is the site of prostatic urethra is the zone where BPH most frequently develops. (Gerald et al., 2011)

Berry and colleagues found histological changes of BPH in 90 percent of men over the age of 80 years old in 1984. Fifty percent of men between age 50-60 years have benign prostatic hyperplasia. (Berry et al., 1984).An enlarged prostate can compress the prostatic part of urethra and cause lower urinary tract symptoms

Lower urinary tract symptoms is a collection of symptoms that can be divided into storage and voiding symptoms. Storage symptoms are increased urgency and frequency and nocturia (waking up at night to urinate frequently). Some patients may be experiencing dysuria (painful micturition). Voiding symptoms are hesitancy, dribbling, poor flow of urine. Patients usually present to clinic when the symptoms lead to an impairment to the patients quality of life.

Benign prostatic hyperplasia (BPH) is the most commonest cause of lower urinary tract symptoms (LUTS) in men over the age of 50 years and is a histologic diagnosis that refers to proliferation of smooth muscles and epithelial cells within the

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transition zones of the prostate gland according to the American Urologic Association (AUA) guidelines for Benign Prostatic Hyperplasia 2010. It causes LUTS via two mechanisms which are direct bladder outlet obstruction and from increased smooth muscle tone and resistance. BPH can be diagnosed clinically when there is LUTS symptoms attributed to an enlarged prostate and proven by pressure flow studies with other causes such as prostate carcinoma has been ruled out based on AUA guidelines for diagnosis.

Aim of treatment of LUTS secondary to BPH is restoring the quality of life of the patient. Therefore its important to have a scoring system that can measure both the voiding and storage symptoms in terms of severity and how it affects patients quality of life .

1.2 INTERNATIONAL PROSTATE SYMPTOM SCORE (IPSS)

Therapeutic decision making for management of BPH is guided by severity of symptoms, the degree of bother and patient preference. American Urological Association (AUA) developed a 7 item questionnaire which was called The AUA Symptom index which was validated by them. It asks about the severity of LUTS namely, incomplete bladder emptying, frequency of urination, intermittency, urgency, weak urine stream, straining and nocturia. Each of the questions is rated from 0 (not at all) to 5 (almost always). The total symptom score is the sum of questions 1–7.

According to the total symptom score, the severity of LUTS can be graded as mild (0–

7), moderate (8–19) and severe (20–35). (Edmond et al., 2014).The World Health Organization modified this symptom index by adding a 8th question on quality of life and renaming it International Prostate Symptom Score (IPSS). The Canadian Urologic Association guideline on management of BPH 2010 recommends IPSS (International

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Prostate Symptom Score) as a formal symptom inventory for objective assesment at initial contact and on follow up. IPSS is also recommended by the American Urological Association as the scoring system to evaluate and follow up patients with BPH and LUTS.

IPSS is currently being used worldwide in tertiary and non tertiary centres to evaluate patient with BPH. IPSS is heavily dependent on the experience of the doctors to obtain an accurate score. It is time consuming in a busy clinic setting in a tertiary hospital. It is also dependent on the understanding of the patient towards the questions asked in IPSS and thus dependent on their education status. One of the major disadvantages of the IPSS is that it is written in English and misinterpretation may occur if the doctors administering it or the patients are not proficient in English language. A prospective study done by Tarun Jindal et al in India in 2014 showed that patient who do not have English as their primary language misinterpret the IPSS questionnaire and there are significant differences in the symptom scores when the IPSS is self administered compared to when they are assisted by a clinician (Tarun et al., 2014).

Although there were many attempt to translate the IPSS into many different languages there is no standardized translation that has been accepted internationally.

1.3 VISUAL PROSTATE SYMPTOM SCORE (VPSS)

There has been a search for a more simplified version of the IPSS that is more practical and easier to use. There have been development of many scoring systems but none has shown potential to replace the IPSS. In 2011 a new scoring system called the visual prostate symptom score was developed which translated the questions in IPSS to a visual scoring system. It has shown good results in many countries in which it was tested and can be considered a viable alternative to IPSS.

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Van der Walt et al came up with the visual prostate symptom score in 2011 which is a scoring system for BPH based on pictograms to assess the force of urinary stream, urinary frequency, nocturia and quality of life. It is designed to be filled up by the patient with low education status with minimal assistance from technical staff or with no assistance. It is designed to be filled in without the involvement of doctors. It has also no language barrier since it consists only of pictograms and no written words is used.

1.4 UROFLOWMETRY

The International Continence Society’s Good Urodynamic Practice Guidelines 2016/GUP 2016 defines urodynamics as the general term to describe all the measurements that assess the function and dysfunction of the LUTS by any appropriate method. Urodynamics allows direct assessment of LUTS function by the measurement of relevant physiological parameters. Urodynamics is divided into invasive and non invasive urodynamics. Invasive urodynamics is defined as any test that is invasive, as it involves insertion of one or more catheters or any other transducers into the bladder and/or other body cavities, or insertion of probes or needles. Non invasive urodynamics is defined as all urodynamics done without the insertion of catheters

Uroflowmetry is a simple and non invasive urodynamic measurement where the patient urinates into a funnel shaped device that measures volume/time of urine accumulation. It measures voided volume, voiding time, average flow rate and Qmax so that voiding pattern can be evaluated and is an excellent screening tool for men with bladder outlet obstruction. (Macdiarmind & Rogers, 2007).

Uroflowmetry plays a vital role in defining the bladder outlet dysfunction and help direct one's therapy.Qmax is the maximum flow rate per second. Qmax is the

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single best measurement in the uroflowmetry and can be used accurately to diagnose bladder outlet obstruction and to follow up progression. (Porru et al., 2002).

Good Urological Practice guidelines 2012/GUP 2012 by the International Continence Society presents uroflowmetry as the first line screening for patients with LUTS. In GUP 2016 the International Continece Society has reconfirmed uroflowmetry as the first line test. The AUA guidelines published by the American Urological Association along with the Society of Urodynamics recommends use of uroflowmetry in the initial and ongoing evaluation of men with lower urinary tract symptoms. Both the GUP 2016 and AUA guidelines recommends the use of uroflowmetry where there is adequate equipment and personnel trained in its use. In Malaysia these are only available at selected urology clinics in tertiary hospitals and equipment is costly to maintain.

1.5 STUDIES ON VPSS

The initial study done by Van Der Walt at a tertiary centre in South Africa aimed to show that VPSS scoring system could be filled by patients with lower education status.

This study aimed to show whether patient could fill up the scoring system without assistance and no comparison was done between VPSS scores and other modalities like IPSS and uroflowmetry. Patients were divided into two groups one with a lower education status (grade <7) and one with a higher education status (grade>10). In the lower education group the IPSS required assistance in 87 percent of patients in the lower education group vs 24 percent in the higher education group (p<0.001). For the VPSS scoring system only 32 percent required assistance in the lower education group and 8 percent in the higher education group. (p=0.14). (CLE van der Walt et al., 2012). This shows that VPSS is easier to be filled up by patients regardless of their education status

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due to the complicated questions in IPSS being translated into easy to understand pictograms. VPSS will prove useful in areas that cater to patients with lower education status. This study was followed by the pilot study comparing VPSS to Qmax by Heyns CF, Van der Walt et al in 2012 which showed a significant negative correlation between total VPSS score and Qmax (r=0.36, p<0.001). (Heyns et al., 2012). In this study assistance was offered during VPSS to the patients who required it.

Various studies have been done on the VPSS scoring system in multiple countries such as India, Pakistan and Korea. In a prospective study done from an Indian population in 2017 there was statistical correlation between total VPSS and Qmax (correlation coefficient=-0.5782 p<0.0001) and correlation between total IPSS and total VPSS (correlation coefficient=0.7235 p<0.0001).(Taneja et al., 2017)

Study done in National Police Hospital in Korea showed that there was a significant corelation between VPSS and Qmax (correlation coefficient -0.269, p<0.001). (Park & Lee, 2014). Study done in Pakistan by Mazhar et al. showed that there was a strong negative correlation between VPSS and Qmax (-0.848). Univariate regression analysis (odds ratio -0.47, p<0.001) and multivariate regression analysis (odds ratio-0.46, p<0.001). It showed that age, voided volume and education status were independent variables. (Mazhar et al., 2014).

Another study done with a rural population from India showed that VPSS can be used instead of IPSS. There was a positive correlation between IPSS and VPSS total score in this study (r = 0.453 and P ≤ 0.001). A negative correlation is also noted between VPSS total score and Qavrg of value 0.497 (P = 0.000) and VPSS total score and Qmax of value - 0.719 (P = 0.000) in a study done by Roy et al. (2016). Study done in Turkey between September 2013 and March 2014 showed negative correlation

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between the Qmax values and both the total IPSS (r = -0.53; P <.001) and the total VPSS (r = -0.3; P <.01), separately. (Ceylan et al., 2015).

Studies done overseas have shown promise that VPSS can be used instead of IPSS in men with benign prostatic hyperplasia. VPSS depends on the understanding of the population towards the pictograms and results may differ across populations. In most of the studies above it was stated that assistance was s offered to the patients who required it to fill up the VPSS score by medical personnel. No studies has been done yet regarding the use of VPSS in a Malaysian setting. No studies done so far have all their patients fill up VPSS on their own without assistance from medical personnel.

1.6 JUSTIFICATION OF THIS STUDY

In Malaysian tertiary setting currently uroflowmetry is being used to follow up patients with benign prostatic hyperplasia to assess symptom severity and response to treatment.

It requires a uroflowmeter which is costly to purchase and to maintain.

In centres where uroflowmetry is not readily available the VPSS or IPSS can be a valid alternative for follow up and treatment of patients with BPH.

Advantages of VPSS compared to IPSS is that it can be filled up easily by patients with minimal education background with minimal guidance. Therefore it saves consultation time. It also has no language barrier for a multiracial population as only pictograms are used instead of words.

Although studies have shown that VPSS can be used in lieu of IPSS no study has been done in Malaysia and no study has been done where VPSS was filled up without any assistance. If VPSS can be filled up by our patients on their own then it can save even more considerable time in our busy clinical setting as patient waiting and

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consultation time will be cut down considerably and will also be applicable to follow up patients in district centres without urological expertise.

1.7 RESEARCH QUESTION

Can the VPSS be filled up by patients on their own without medical personnel assistance and does the result correlate with uroflowmetry.

1.8 RESEARCH OBJECTIVE

To determine the correlation between visual prostate symptom score that is filled up without assistance and uroflowmetry (Qmax) among BPH patients undergoing treatment in Urology Clinic in a tertiary centre in Malaysia.

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CHAPTER TWO

MATERIALS AND METHODS

2.1 STUDY DESIGN

This is a prospective cross sectional study

2.2 STUDY PERIOD

Study period is from January 2018 till June 2018

2.3 STUDY PARTICIPANTS

Male patients over 50 years of age from Kuantan undergoing treatment for BPH at urology outpatient clinic, Hospital Tengku Ampuan Afzan, Kuantan

2.4 SELECTION CRITERIA

74 patients were willing to participate in this study and fulfill the selection criteria

2.4.1 Inclusion Criteria

1. Clinical symptoms of LUTS like hesitancy, poor stream, post micturition dribbling, increased urgency and frequency, nocturia

2. Digital rectal examination finding of an enlarged smooth prostate with median sulcus felt

3. Prostate specific antigen (PSA<4.0 Nanograms per milliliter OR PSA>4.0 Nanograms per milliliter with negative Transrectal Ultrasound Guided Biopsy of Prostate (TRUS).

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2.4.2.1 Urinary Stricture

Findings of extended urination time and low plateau curve on uroflow which is diagnostic of urethral stricture

2.4.2.2 Prostate Carcinoma

Findings of hard fixed, irregular enlargement of prostate OR a positive TRUS biopsy of prostate carcinoma.

2.4.2.3 Voided volume

Patients with voided volume less than 100 ml will be discarded.

2.5 STUDY LOCATION

Study was carried out in Urology Clinic Hospital Tengku Ampuan Afzan, Kuantan

2.6 SAMPLING 2.6.1 Sampling Method

Simple random sampling method was used in this study. The random sampling was done by taking the number of patients scheduled for follow up for BPH in a 6 month duration and putting the names into a box and drawing out 74 names.

2.6.2 Sample Size Estimation

Sample size of 74 obtained using sample size calculator (Hulley et al., 2013) r=0.36

Type 1 error α=5%

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11 Type 2 error β=20%

Calculated sample size=59 Anticipated dropout rate=20%

Corrected sample size=74

r=0.36 based on pilot study by Heyns, van der walt et al. (2012)

2.7 ETHICAL CONSIDERATIONS AND CONFIDENTIALITY

This study has been registered with Medical Research and Ethics Committee, Ministry of Health Malaysia with project code of Confidential protections of all the information obtained were protected as per Good Clinical Practice Guidelines Third Edition 2011.

(Malaysia, 2011)

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2.8 INSTRUMENTS AND RESEARCH TOOLS 2.8.1 Research Tools

2.8.1.1 Uroflowmetry device

Figure 2.1 Flowmaster PC based wireless uroflowmetry by Medical Measurement Systems US

COMPARISON BETWEEN VISUAL PROSTATE SYMPTOM SCORE AND FLOW RATE IN BENIGN

COMPARISON BETWEEN VISUAL PROSTATE SYMPTOM SCORE AND FLOW RATE IN BENIGN

PROSTATIC HYPERPLASIA (BPH):

A CROSS SECTIONAL STUDY

BY

NARAYANAN A/L KATHIRESAN

A dissertation submitted in fulfilment of the requirement for the degree of Master of Surgery (General Surgery)

Kulliyyah of Medicine

International Islamic University Malaysia

NOVEMBER 2018

ABSTRACT

APPROVAL PAGE

DECLARATION

COPYRIGHT

INTERNATIONAL ISLAMIC UNIVERSITY MALAYSIA

DECLARATION OF COPYRIGHT AND AFFIRMATION OF FAIR USE OF UNPUBLISHED RESEARCH

COMPARISON BETWEEN VISUAL PROSTATE SYMPTOM SCORE AND FLOW RATE IN BENIGN PROSTATIC HYPERPLASIA (BPH): A CROSS SECTIONAL STUDY

DEDICATION

ACKNOWLEDGEMENTS

TABLE OF CONTENTS

LIST OF TABLES

LIST OF FIGURES

CHAPTER ONE

INTRODUCTION AND LITERATURE REVIEW

CHAPTER TWO

MATERIALS AND METHODS