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The Role of Dutasteride in the Treatment of Gross Haematuria Due to Benign Prostatic Hyperplasia and Adenocarcinoma of the Prostate

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The Role of Dutasteride in the Treatment of Gross Haematuria Due to Benign Prostatic Hyperplasia and Adenocarcinoma of the Prostate 1 THE ROLE OF DUTASTERIDE IN THE TREATMENT OF GROSS HAEMATURIA DUE TO BENIGN PROSTATIC HYPERPLASIA AND ADENOCARCINOMA OF THE PROSTATE DR OFURU, VITALIS OBISIKE NOVEMBER 2014 2 DECLARATION I hereby declare that all parts of this work were carried out by me under the quidance of my supervisors except where otherwise declared. It has neither been presented to any other college for a Fellowship nor submitted elsewhere for publication. ……………………………………………. DR OFURU VITALIS OBISIKE DEDICATION 3 This work is dedicated to my two little kids Udochi and Chika who have not had much of my care and companionship in these past years. ACKNOWLEDGEMENT 4 I thank the Almighty God who sustained me through the rigors of training and helped me to put together this piece of work. My inestimable thanks go to Emeritus Professor O.O Mbonu for his advice and support during the time of writing the proposal. I cannot thank enough Professor Ndu Eke and Professor A.M.E Nwofor who took pains to supervise this work, and went through it each time I made it available to them. They carefully made corrections and contributions that made the work feasible. Professor Okpani also guided me at the beginning. To him I remain grateful. I wish to thank Dr. O.N. Ekeke and Dr M.K. Sapira who also supervised me in this work. Dr Sapira suggested this topic to me and critiqued the work such that I almost got discouraged. To say the least, the work couldn’t have been successful without his contributions. I remain grateful to Drs Timothy Mbaeri, Ezisi Chinyelu, John Ojule, Joseph Abiahu, Emmanuel Amusan, Chinedu Anyadike and Victor Abhulimen and all others whose names are not mentioned here, who either helped me to collect data in course of this work, or encouraged me in one way or the other. Lastly, I appreciate my loving mother Mrs Edna Ofuru, for her sacrifice, prayers and encouragement throughout the period of my training. 5 CERTIFICATION This is to certify that the study titled ‘The role of dutasteride in the treatment of gross haematuria due to benign prostatic hyperplasia and adenocarcinoma of the prostate’ reported in this dissertation and the writing thereof were done by the candidate under our supervision. Prof. N. Eke FRCS Ed, FRCS (Engl), FWACS, FICS …………………………………………… Consultant Urologist University of Port Harcourt Teaching Hospital, Port Harcourt. Prof. A.M.E. Nwofor BM: BCh, FMCS, FWACS,FACS, FICS, FISS…………………… Consultant Urologist Nnamdi Azikiwe University Teaching Hospital, Nnewi Dr. O. N. Ekeke FWACS, FICS ……………………………………....................... Consultant Urologist University of Port Harcourt Teaching Hospital, Port Harcourt. 6 Dr. M.K. Sapira FWACS, FMCS, FICS …………………………………………………………… Consultant Urologist University of Port Harcourt Teaching Hospital, Port Harcourt. TABLE OF CONTENTS Contents Page Title page ……………………………………………………………………………………………………… i Declaration ………………………………………………………………………………………………….. ii Dedication …………………………………………………………………………………………………….iii Acknowledgement…………………………………………………………………………………………i v Certification ……………………………………………………………………………………………………v Table of contents …………………………………………………………………………………………..vi List of figures …………………………………………………………………………………………………vii List of tables ………………………………………………………………………………………………...viii List of abbreviations ……………………………………………………………………………………….ix Summary……………………………………………………………………………………………………….. .xi CHAPTER 7 1. Introduction ………………………………………………………………………………………….1 2. Literature Review ………………………………………………………………………………… 5 3. Aims and Objectives …………………………………………………………………………….29 4. Materials and Method ………………………………………………………………………….30 5. Results ………………………………………………………………………………………………….39 6. Discussion …………………………………………………………………………………………….63 References ……………………………………………….……………………………………………………76 Appendix I – Proforma…………………………………………………………………………………86 Appendix II – Ethical committee approval ……………………………………………………..93 LIST OF FIGURES Figure 1: Frequency distribution of patients by age …………………………39 Figure 2: Frequency distribution of duration of haematuria before presentation……………………………………………………………………………………..40 Figure 3: Kaplan-Meier analysis for duration of haematuria………………50 8 LIST OF TABLES Table 1: Puchner and Miller classification of severity of Prostatic haematuria…13 Table 2: Mean prostate size by diagnosis ( T- test analysis)…………….……………….42 Table 3: Mean prostate size by treatment ( T- test analysis)……………………………43 Table 4: Correlation analysis of prostate size by duration of haematuria………..44 Table 5: Mann-Whitney test for Serum PSA of respondents……………………….….45 9 Table 6: Diagnosis and type of treatment………………………………………………………47 Table 7: The minimum and maximum duration of haematuria (in days) and mean duration of haematuria (in days) for each diagnosis and for each treatment type……………………………..……………………………………………………………….49 Table 8: Means and Median for Survival time………………………………………………..52 Table 9: Percentile table for Survival Curve……………………………………………………53 Table 10: Overall comparison of probability of resolution of haematuria using Log Rank, Wilcoxon and Tarone-Ware tests……………………………………………………54 Table 11: Cross-tabulation of diagnosis and treatment showing mean volume of irrigant fluid used before haematuria stopped and 2 sample student t – test and p-value …………………………………………………………………………………………………………56 Table 12: Fisher’s Exact test for need for surgery when dutasteride is included……………………………………………………………………………………………………….. 58 Table 13: Requirement for blood transfusion…………………………………………….….59 Table 14: Recurrent haematuria after initial resolution…………………………..…….60 10 LIST OF ABBREVIATIONS Chapter 1 : BPH- Benign Prostatic Hyperplasia UTI- Urinary Tract Infection Chapter 2: MVD- Microvascular Density VEGF- Vascular Endothelial Growth factor HIF – Hypoxia Inducible Factor NADP- Nicotinamide Adenine Dinucleotide Phosphate DHT- Dihydrotestosterone T- Testosterone α- Alpha CaP- Carcinoma of the Prostate LUTS- Lower Urinary Tract Symptoms TURP- Trans Urethral Resection of the Prostate EACA – Epsilon Aminocaproic Acid Chapter 4 UPTH- University of Port Harcourt Teaching Hospital PSA- Prostate Specific Antigen IVU- Intravenous Urogram SPSS- Statistical Package for Social Sciences Appendix PCV- Packed Cell volume Hb- Haemoglobin WBC-White Blood Count DRE- Digital Rectal Examination 11 BCG- Bacille Calmette – Gue ’rin E/U/Cr- Electrolyte, Urea and Creatinine SUMMARY OBJECTIVE: To evaluate the clinical effectiveness of dutasteride in the treatment 12 of gross haematuria due to benign prostatic hyperplasia and adenocarcinoma of the prostate by determining the time it took haematuria to stop and the amount of irrigation fluid used while using dutasteride as the primary mode of treatment. BACKGROUND: Dutasteride, a dual 5-alpha reductase inhibitor has been found to reduce bleeding from the prostate in a long term by inhibition of angiogenesis, and by apoptosis and has been used preoperatively to reduce bleeding that occurs during prostatectomy. Would the drug be effective in the control of acute haematuria of prostatic origin and so be used as a preliminary mode of treatment? MATERIALS AND METHOD: Consecutive patients with gross haematuria were evaluated for the causes of haematuria. Seventy five of them identified to be of prostatic origin were further stratified as benign prostatic hyperplasia (BPH), or cancer of the prostate (CaP) based on clinical, biochemical and histologic evidence and randomized to 0.5mg dutasteride and normal saline irrigation on one arm and normal saline irrigation only as control, on the other arm. The time 13 taken for haematuria to stop, the volume of irrigation fluid used, the number of patients that had recurrence, the number of patients transfused, the units of blood transfused and the number of patients that required surgery before haematuria stopped were recorded on both arms. Statistical analysis was done using SPSS version 20.0. RESULTS: Of the 75 cases, 49 (65.3%) had BPH while 26 (34.7%) had CaP. Twenty five (51%) of the 49 patients with BPH had normal saline irrigation only while 24 (49%) had dutasteride in addition to normal saline irrigation. Fourteen (53.3%) of 26 patients with CaP had normal saline irrigation while 12 (46.2%) had dutasteride in addition to normal saline irrigation. Haematuria took a significantly shorter time to stop in those that had 0.5mg dutasteride (4.9 days) than those who had only normal saline irrigation(8.0 days)(p=0.001). Volume of irrigation fluid used was also significantly less in those that had dutasteride than in those who had only normal saline irrigation (10 litres and 21 litres respectively) for BPH patients ( p=0.008) and 8 litres and 17 litres respectively for CaP patients ( p= 0.000). Inclusion of dutasteride did not however significantly reduce the need for surgery. CONCLUSION: The result of this study shows that addition of oral dutasteride 14 0.5mg to normal saline irrigation is effective as a preliminary mode of treatment for cases of gross heamaturia caused by BPH and CaP. KEYWORDS: Haematuria, prostate, benign prostatic hyperplasia, adenocarcinoma of prostate, normal saline irrigation, dutasteride. CHAPTER ONE INTRODUCTION Haematuria is the passage of blood in the urine. It has been described as a danger signal that should not be ignored.1 It may be gross or microscopic. Microscopic haematuria is the presence of more than five red blood cells per high power field. Gross (macroscopic) haematuria is overt and is often a cause of panic to the patient and the attending medical staff. Haematuria may also be described as initial, total or terminal in relation to the flow of urine.
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