Effect of digital rectal examination on prostate specific antigen levels among patients with lower urinary tract symptoms in Uganda | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Effect of digital rectal examination on prostate specific antigen levels among patients with lower urinary tract symptoms in Uganda Brian Musinguzi, Balaam Ndunda, Joshua Muhumuza, Fiston Kinyamaniyi Kamabu, and 3 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-2121937/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Introduction Prostatic cancer is a major contributor to mortality among men globally. Prostate-specific antigen (PSA) is a screening investigation for cancer of the prostate. The combination of serum PSA and digital rectal examination (DRE) allows early detection of prostate cancer. Studies have revealed that DRE causes an elevation in serum PSA levels. This rise following DRE may be mistaken for the rise associated with malignancy. Most clients in our setting come to the urology clinic as referrals from primary physicians when DRE has been done. There is a significant knowledge gap regarding whether the PSA change following DRE is significant enough to warrant withholding PSA measurement in these patients that come after having DRE; the reason this study was done. Methods This was a single centre prospective longitudinal study done at Ishaka Adventist hospital in which an interviewer administered questionnaire was filled for each patient that consented. After filling the questionnaire, a venous blood sample was drawn, DRE done and 1-hour later, another blood sample drawn. Total PSA was measured for both samples and data analyzed using SPSS version 22. Results Data for 102 participants was analyzed, whose mean age was 61.85 ± 12.73 years. The paired samples T test revealed a small mean increase in PSA following DRE (0.40 ng/ml) that was not significant (p = 0.061). The number of patients whose clinical decision would be affected (changed) by the PSA measured after DRE was 3 (2.9%, CI = 0.0%-6.9%) if cutoff was 3 ng/ml and 2 (2.0%, CI = 0.0%-4.9%) at 4 ng/ml cutoff. The confidence intervals in both scenarios included 0.0%, suggesting that there would be no significant effect on the clinical decision if the PSA was done post DRE. Conclusion . DRE can be used in screening and clinical assessment of prostate cancer without fear of interfering with PSA result interpretation and patient management. Prostate specific antigen Digital rectal exam Prostate cancer Figures Figure 1 Figure 2 Figure 3 Background Prostatic malignancy is the second commonest cancer and major contributor to mortality among males in Sub-Saharan Africa, ranking fifth globally ( 1 ). Over the last 20 years, in sub-Saharan Africa alone, there has been increase in diagnosis and mortality arising from several malignancies attributed to change in way of life, behaviors and environment ( 2 ). In Uganda prostate cancer rate was reported to be 65.0 per 100,000, with a mortality-to-incidence ratio of 71% ( 3 ). Prostate-specific antigen (PSA) is a screening investigation for cancer of the prostate and also gives information about the extent of the malignancy, as well as the disease trajectory during monitoring and therapy ( 4 ). Once a year, men at the age of 50 or more should visit a urologist to have a clinical examination of the prostate through the rectum in addition to prostate specific antigen laboratory investigation ( 5 ). For those with a family history of prostate cancer or an afro descent, this check should start at the age of 40.( 5 ). Total prostate specific antigen above 4 ng/ml is currently considered pathologic, and values above 10 ng/ml are strongly suggestive of cancer ( 6 ). Concepts including age cutoff, PSA velocity and free PSA were created to improve PSA sensitivity ( 7 ). PSA is known to be a prostate-specific marker but procedures such as DRE, colonoscopy and prostate biopsy can change PSA levels ( 8 ). PSA levels are thought to rise in direct proportion to the procedure's stimulation intensity ( 9 ). The serum PSA test and digital rectal examination (DRE) allow doctors to detect prostate cancer when it is still in its early stages ( 10 ). Studies have revealed that DRE causes an elevation in serum PSA levels ( 11 ). Following DRE, the PSA starts to raise at 10 munities, reaches its highest level at 1 hour and the effect can last up to 3 weeks ( 12 ). This rise following DRE may be mistaken for the rise associated with malignancy of the prostate resulting in miss-diagnosis when PSA is used to screen ( 10 , 13 ). For this reason, it has been recommended to perform PSA before DRE ( 14 ). Currently, both digital rectal examination and prostate specific antigen done at the same time are recommended for prostate cancer screening because this technique offers up to 75% diagnostic sensitivity for prostate carcinoma ( 14 , 15 ). PSA testing, digital rectal exam (DRE), and prostate biopsy are the cornerstone of prostate cancer screening ( 15 ). Most clients in our setting come to urology clinic as referrals from primary physicians when DRE has been done. This pauses a challenge in interpretation of PSA test values with potential for many falsely positive results resulting in unnecessary invasive procedures, pain, erectile dysfunction, and urinary incontinence, as well as prostate cancer over diagnosis and overtreatment. There has been a significant knowledge gap regarding the extent to which DRE increases PSA levels and whether this change could lead to DRE being withheld before PSA measurement in prostate cancer screening. This study was aimed at assessing the extent of PSA change following DRE among men above 40 years presenting with lower urinary tract symptoms (LUTS). Methods Study design The study was a single Centre prospective longitudinal study Study Setting. The study was done at Ishaka Adventist Hospital (IAH) which is located in Ishaka municipality Bushenyi district approximately 60 kilometers (39 miles) West of Mbarara district in western Uganda. IAH has two surgeons running the surgical clinic, it treats 50 patients seeking urology care in a month. Patients were reviewed from the outpatient department from Monday to Friday. The hospital has a fully functional laboratory that caters for PSA testing and theater services for prostate biopsy. Study Population The study targeted men above 40 years in Bushenyi district, that presented with lower urinary tract symptoms (LUTS) to the outpatient clinic during the period of the study. Sample Size Determination Daniel formula ( 16 ); n = Z 1−α/2 2 p(1-p) / d 2 was used to determine the sample size, where n = estimated minimum sample size required, P = proportion of characteristic in a sample, Z 1−α/2 =1.96 (for 95% Confidence interval), e = Margin of error set at 5%. Using findings by ( 17 ) who reported the incidence of cancer of the prostate to be 6.4% in Uganda, n= (1.96) 2 x 0.064 (1-0.064)/ (0.05) 2 , n = 92. To increase the internal validity of study and catering for non-responders, the calculated sample size was increased by 10% giving an estimated sample size of 102. Sampling Technique Consecutive recruitment was used until the desired sample size was achieved. Male patients who presented to the surgical outpatient department with LUTS were enrolled following informed consent. Eligibility Criteria Inclusion criteria Men above 40 years with LUTS at surgical outpatient department who consented to participate in the study Exclusion criteria Patients with indwelling urethral catheters were excluded in addition to those with a history of prostatectomy, those who had undergone trans-rectal ultrasound scan over the previous one month and those with a history of urogenital trauma. Data Collection Procedure And Psa Measurement All patients that were eligible for the study signed a Kampala international university Research and Ethics committee (KIU-REC) format consent form after explaining to them the details of the consent. After consenting, a questionnaire that was pretested and interviewer administered was filled for each patient that consented. After filling the questionnaire, a sample of Venus blood was drawn aseptically for PSA analysis. A digital rectal exam was done and then 1-hour later, another sample for PSA testing was drawn and all samples were analyzed in the hospital laboratory. Patient’s venous blood was collected in a sterile Vacutainer tube without anticoagulant and centrifuged for serum separation and total serum PSA was measured using, i chroma machine (i-CHROMA™). The same machine was used for all samples. Digital rectal examination Patient was positioned in the left lateral position with the left leg extended and the right flexed at the knee in the doctor’s examination room with adequate privacy. A double gloved index finger was gently introduced into the rectum via the anal opening after lubricating with K-y jelly. Using the index finger, the prostate was palpated, and assessment made as to whether it is enlarged or not, symmetrical or asymmetrical, nodular or non-nodular, soft, firm or hard, tender or non-tender, palpable groove or obliterated groove, with free mucosa or fixed mucosa. The findings were documented after cleaning the perianal area. Quality Control Inclusion and exclusion criteria were strictly adhered to. The research team was instructed on how to administer the questionnaire. The data collection tool was cross checked for completeness. The same equipment was used to measure PSA for all samples. Controls were run regularly. Data analysis and presentation Data was coded and entered in excel sheet, and analyzed using SPSS version 22. Frequencies and percentages were used to describe categorical variables while mean and standard deviation were used for continuous variables. To determine the change in PSA following DRE, the PSA values for the patients before and after DRE were entered as continuous variables. Using the paired samples T test procedure, the mean difference between the pre and post DRE PSA level was determined with the corresponding standard deviation and p value. If the corresponding p value was less or equal to 0.05, the difference was considered significant. The values of pre and post DRE PSA were compared for each patient to determine if the post DRE PSA would have affected (changed) the clinical decision in order to assess the clinical significant of the PSA changes. Results During the study period, 114 patients presented to the study centre with a history of lower urinary tract symptoms. 10 of the 114, had a urethral catheter inserted before arrival to the study centres. 2 of the remaining had prostatectomy in the previous years. PSA was done for 102 patients as shown in Fig. 1 . Social-demographic characteristics of the study participants In this study, the mean age of the participants was 61.85 ± 12.73 years and the mean BMI was 24.27 ± 4.17. Majority of the participants were from the rural areas (80.4%), married (92.2%), with maximum level of education as primary (60.8%) and peasants (64.7%) as shown in Table 1 . Table 1 shows the social-demographic characteristics of the study participants. Characteristic Statistic Age Mean = 61.85, SD = 12.73, Min = 40, Max = 95 Body mass Index (BMI) Mean = 24.27, SD = 4.17, Min = 14.53, Max = 38.57 Frequency Percentage Age Category 40–50 23 22.5 51–60 26 25.5 61–70 26 25.5 71–80 21 20.6 81–100 6 5.9 BMI Category 14.53–18.50 6 5.9 18.51–29.99 90 88.2 30.00- 38.57 6 5.9 Residence Rural 82 80.4 Urban 20 19.6 Marital status Married 94 92.2 Single 3 2.9 Windowed 4 3.9 Divorced 1 1.0 Education Level Primary 62 60.8 Secondary 22 21.6 Tertiary 16 15.7 No Education 2 2.0 Occupation Peasant 66 64.7 Business 19 18.6 Formal Employment 14 13.7 Driver 3 2.9 SD = Standard deviation, Min = minimum, Max = Maximum, BMI = Body mass Index. Effect of Digital rectal examination on PSA levels In this study, it was noted that in some patients, the PSA after DRE was lower than that done before the rectal exam, yet in others it remained the same or increased as shown in Table 2 . Table 2 Showing the type of PSA change observed Change type Frequency Percentage Mean Pre DRE PSA Mean for post DRE PSA Mean PSA change Decrease 29 28.5 4.86 4.31 0.55 Same 19 18.6 7.25 7.25 0.00 Increase 54 52.9 4.62 5.70 1.08 On plotting the means of PSA in each age category both the mean pre and post DRE PSA ware seen to increase with age. We observed that the mean Post DRE PSA was lower than the pre-DRE in patients who had a PSA below 6 ng/ml as shown in Fig. 2 . The paired samples T test revealed that there was a small mean increase in PSA following DRE (0.40 ng/ml). This increase was not statistically significant (p = 0.061). Table 3 shows the result of the paired samples T test. The findings of the paired samples T test were supported by a scatter plot which revealed a perfect correlation (R 2 = 0.975) between the pre and post DRE PSA as shown in Fig. 3 . Table 3 shows the result of the paired samples T test. Characteristic Pre DRE PSA Post DRE PSA Mean 5.18 5.59 Standard deviation 12.86 13.35 Mean difference -0.40 Standard error of the mean difference 0.21 Confidence interval of the mean difference -0.817 to 0.020 P value of mean difference 0.061 DRE = Digital rectal exam, PSA = Prostate specific antigen R 2 = Pearson Correlation coefficient, DRE = Digital rectal exam, PSA = Prostate specific antigen It was also observed that the number of patients whose clinical decision would be affected (changed) by the PSA measured after DRE was 3 (2.9%, CI = 0.0%-6.9%) if cutoff was 3ng/ml and 2 (2.0%, CI = 0.0%-4.9%) at a cutoff of 4ng/ml. The confidence intervals in both scenarios included 0.0%, suggesting that there would be no significant effect on the clinical decision if the PSA was done post DRE as shown in Table 4 . Table 4 shows the impact of change in PSA on Clinical decision Cutoff Effect on decision Frequency percentage 95% CI 3.00 ng/ml No change in decision 99 97.1 93.1–100.0 Change in decision 3 2.9 0.0-6.9 4.00 ng/ml No change in decision 100 98.0 95.1–100.0 Change in decision 2 2.0 0.0-4.9 Discussion There has been insufficient data about the effect of DRE on PSA in men above 40 years with LUTS in Uganda and sub-Sahara Africa in general. Despite DRE and PSA being the cornerstones of cancer of prostate screening their interplay has not been studied in our setting. Most studies have been performed in white population thus making this the first study to assess the effect of DRE on PSA in Africa. Our study showed that 29.5% (29 patients) of the study participants had a decrease in PSA with an average decrease of 0.55 ng/ml. In 18.6% (19 patients) there was no change in PSA. 52.9% (54 patients) had increase in PSA with an average increase of 1.08 ng/ml. The above results confirm that DRE affects PSA values, however the decrease in the PSA values after DRE seen in 29.5% of the participants could be explained by the acceptable margin of error of the equipment. Further analysis revealed that DRE slightly increased the level of PSA with a mean difference of 0.4 ng/ml however this change was statically insignificant with a p value of 0.061. This was similar to a study done in Nigeria by Eshiobo ( 8 ) who observed that DRE caused an increase in PSA of 8 to 13% however this was statistically insignificant. In a study that enrolled 199 men in the USA, it was noted that the DRE caused a non-significant increase in PSA ( 18 ). Contrally to our findings, significant changes in PSA were seen by Crawford et al ( 19 ) in some males with pre-DRE PSA levels under 4.0 ng/mL, however, the clinical significance of the changes were not reported. Chybowski et al ( 20 ) evaluated the effects of DRE in 71 males who had prostatic diseases and 72 controls and noted that some men with initial PSA values up to 4.0 ng/mL presented a statistically significant increase of serum PSA, however the changes were not clinically significant as was seen in this study. Study Limitations This study was hospital based, assessing males who already had lower urinary tract symptoms which to a large extent, may have influenced the values of PSA in this study population. There is need for a community based study in these rural areas in preparation for properly regulated screening programs in sub Saharan African countries. Conclusion This study revealed that the change in PSA following DRE was not significant both statistically and clinically. Therefore DRE can be used in screening and clinical assessment for cancer of the prostate without fear that it would interfere with PSA value interpretation and patient management. Abbreviations PSA= Prostate specific antigen, DRE: Digital rectal examination, LUTS= Lower urinary tract symptoms, CI= Confidence interval. Declarations Ethical considerations and consent: All methods were carried out in accordance with relevant guidelines and regulations. The study was approved by the Kampala international university research and ethics committee reference number UG-REC-023/202207. A voluntary and non-coercive recruitment was sought leading to signing of a written informed consent form following thorough explanation to the participant about the study. All the participants provided written informed consent. The Uganda National Guidelines for currying out research during the COVID- 19 pandemic (UNCST, 2020) were also followed. Consent for publication: The patient data was anonymised, no patient identifying characteristics are submitted for publication. Availability of data and materials: Data is available upon request. Requests should be sent to BM Via [email protected] Competing interests : The authors declare that they have no conflict of interest Sources of funding : This study did not receive any specific grant from funding agencies in public, commercial, or not for profit sectors. Author contribution: BM was the principle investigator, conceived and designed the study, collected data, analysed data and wrote the draft of the manuscript. JM participated in data analysis, discussion of results and critically revised the manuscript, TH, FKK and MJO participated in discussion of results and critically revised the manuscript, BN and XFO supervised the work, critically revised the manuscript and all authors approved the final paper. Acknowledgements: We acknowledge all patients that accepted to participate in this study. Guarantor: BM References Mbugua RG, Oluchina S, Karanja S. Prostate cancer awareness and screening among men in a rural community in Kenya: a cross-sectional study. African J Urol. 2021;27(1). Engel JC, Palsdottir T, Aly M, Egevad L, Eklund M, Nordström T, et al. Lower urinary tract symptoms ( LUTS ) are not associated with an increased risk of prostate cancer in men 50 – 69 years with PSA ≥ 3 ng / ml. Scand J Urol [Internet]. 2020;54(1):1–6. Available from: https://doi.org/10.1080/21681805.2019.1703806 Okuku F, Orem J, Holoya G, Boer C De, Thompson CL, Matthew. Prostate Cancer Burden at the Uganda Cancer Institute. Am Soc Clin Oncol. 2015;(March). Lewis DD, Cropp CD. The impact of African ancestry on prostate cancer disparities in the era of precision medicine. Genes (Basel). 2020;11(12):1–28. Soares SCM, De Camargo Cancela M, Migowski A, De Souza DLB. Digital rectal examination and its associated factors in the early detection of prostate cancer: A cross-sectional population-based study. BMC Public Health. 2019;19(1):1–11. Little B, Ho KJ, Gormley G, Young M. PSA testing in general practice. Prosate cancer prostatic Dis. 2003;6(2):154–8. Nordstrom T, Akre O, Aly M et al. PSA Density in the diagnostic alogrithm of prosrare cancer. Prostate cancer prostatic dis. 2018;21:57–63. Irekpita E, Owobu C, Aigbe E, Obasikene G, Igbe A. Assessment of DRE and PSA as Diagnostic and Screening Tools for Carcinoma of the Prostate in Rural Nigeria. 2014;19(3):53–8. Kim JS, Ryu J, Kim JW, Hwang EC, Jung S Il, Kang TW, et al. Prostate-Specific Antigen fluctuation : what does it mean in diagnosis of prostate cancer ? _______________________________________________. 2015;41(2):258–64. Prcic A, Begic E. Usefulness of Total PSA Value in Prostate Diseases Diagnosis. 2016;24(3):156–61. Al Rumaihi K, Al Jalham K, Younes N, Majzoub AA, Shokeir AA. The role of an abnormal prostate-specific antigen level and an abnormal digital rectal examination in the diagnosis of prostate cancer: A cross-sectional study in Qatar. Arab J Urol. 2013;11(4):355–60. Koo KC, Park SU, Kim KH, Rha KH, Hong SJ, Yang SC, et al. Predictors of survival in prostate cancer patients with bone metastasis and extremely high prostate-speci fi c antigen levels. Prostate Int [Internet]. 2015;3(1):10–5. Available from: http://dx.doi.org/10.1016/j.prnil.2015.02.006 Hirachand S, Ums D, Pradhanang S, Acharya S. Study of prostatic pathology and its correlation with prostate specific antigen. 2017;7:1074–7. Naji L, Randhawa H, Sohani Z, Dennis B, Lautenbach D, Kavanagh O, et al. Digital rectal examination for prostate cancer screening in primary care: A systematic review and meta-analysis. Ann Fam Med. 2018;16(2):149–54. Irekpita E, Achor GO, Alili U. Assessment of the value of the different variants of abnormal digital rectal examination finding in predicting carcinoma of the prostate: a preliminary report of a two-center study. African J Urol. 2020;26(1). Daniel W. Biostatistics: A foundation for analysis in Health sciences. 7th Editio. Sons J wiley and, editor. New York; 1999. Katongole P, Sande OJ, Yusuf M, Joloba M, Reynolds SJ, Niyonzima N. Clinical characteristics and primary management of patients diagnosed with prostate cancer between 2015 and 2019 at the Uganda Cancer Institute. PLoS One [Internet]. 2020;15(10 October):6–12. Available from: http://dx.doi.org/10.1371/journal.pone.0236458 William JC, Smith D s, Ratliff T, Dodds KM, Coplen DE, Yuan J, et al. Measuremt of PSA in serum as a screening test for prostate cancer. N Engl J Med. 1991;324(17):1156–61. Crawford DE, Schutz, Clejan MJ, Drago S, Resnick J, Chodak MI, et al. The effect of DRE on PSA levels. Jaun Am Med Assoc. 1992;267(16):2227–8. Chybowski FM, Bergstralh E j, Oesterling JE. The Effect of DRE on serum PSA concetration: Results of a randomised study. jounal Urol. 1992;148(1):83–6. Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-2121937","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":141951462,"identity":"8dbb1968-a8e2-45c1-865b-6ae2c814afb1","order_by":0,"name":"Brian Musinguzi","email":"","orcid":"","institution":"Kampala International University Western Campus","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Brian","middleName":"","lastName":"Musinguzi","suffix":""},{"id":141951463,"identity":"26a900fb-3578-4748-9c8a-35cd476f1d6c","order_by":1,"name":"Balaam Ndunda","email":"","orcid":"","institution":"Makerere University","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Balaam","middleName":"","lastName":"Ndunda","suffix":""},{"id":141951464,"identity":"5e4ef1e9-c295-41cd-8894-56519342b993","order_by":2,"name":"Joshua Muhumuza","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABAklEQVRIiWNgGAWjYBACxgYGNiB1QAbM4/1nAxJrPECMFh4wj4ctDSyGVwsQoGg5DKbxamFub3/2mKfmDg8///GHD97wnLdb234YaEuNTTROh/WcMTfmOfaMR3JGjrHhHInbydvOJAK1HEvLbcClZUYOmzTQPTwGN3iADIPbyWYHgFoYGw7j0ZL+TJrn32Ee+/PHn//mSTiXbHb+ISEtCWbSvG1AWxgSzJh5DhywM7tByJaeM2aSc/ue8UjcyDGWnNuQnGB2A2hLAh6/GAJDTOLNtzty/P3HH35422Bnb3Y+/eGDDzU2uLWgSySCBRJwKAcBeXQBezyKR8EoGAWjYIQCAF/WZDcdTC3YAAAAAElFTkSuQmCC","orcid":"","institution":"Kampala International University Western Campus","correspondingAuthor":true,"submittingAuthor":false,"prefix":"","firstName":"Joshua","middleName":"","lastName":"Muhumuza","suffix":""},{"id":141951465,"identity":"d684403e-1135-4dca-8bd7-f47cdb64b748","order_by":3,"name":"Fiston Kinyamaniyi Kamabu","email":"","orcid":"","institution":"Kampala International University Western Campus","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Fiston","middleName":"Kinyamaniyi","lastName":"Kamabu","suffix":""},{"id":141951466,"identity":"61648c0b-e109-4ef2-9083-b3bb54b5eec8","order_by":4,"name":"Theoneste Hakizimana","email":"","orcid":"","institution":"Kampala International University Western Campus","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Theoneste","middleName":"","lastName":"Hakizimana","suffix":""},{"id":141951467,"identity":"4441e313-f9f6-46dc-a922-04a7aae1e180","order_by":5,"name":"Mohamud Jelle Osman","email":"","orcid":"","institution":"Kampala International University Western Campus","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Mohamud","middleName":"Jelle","lastName":"Osman","suffix":""},{"id":141951468,"identity":"19d70573-711d-4a64-ab3a-c9234f4afce5","order_by":6,"name":"Xaviour Francis Okedi","email":"","orcid":"","institution":"Kampala International University Western Campus","correspondingAuthor":false,"submittingAuthor":false,"prefix":"","firstName":"Xaviour","middleName":"Francis","lastName":"Okedi","suffix":""}],"badges":[],"createdAt":"2022-09-30 21:44:15","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-2121937/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-2121937/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":27674773,"identity":"e31b34aa-11e6-4b93-bcaa-bd8bfc7b5bb1","added_by":"auto","created_at":"2022-10-12 14:24:37","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":27293,"visible":true,"origin":"","legend":"\u003cp\u003eshows the study procedure and the corresponding numbers.\u003c/p\u003e\n\u003cp\u003e\u003cbr\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-2121937/v1/e934ac6b7a266aa2b24a76f8.png"},{"id":27674771,"identity":"c452f4b7-7a1b-42a5-b943-99a5cbeed027","added_by":"auto","created_at":"2022-10-12 14:24:37","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":25216,"visible":true,"origin":"","legend":"\u003cp\u003eshowing the mean PSA change per age category\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-2121937/v1/461cd311819de731d2160c8c.png"},{"id":27675890,"identity":"214f4440-c91f-4aee-9d9d-5b81f9617b1d","added_by":"auto","created_at":"2022-10-12 14:29:37","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":14377,"visible":true,"origin":"","legend":"\u003cp\u003eis a scatter plot that shows the relationship between pre and post DRE PSA.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eR\u003c/em\u003e\u003csup\u003e\u003cem\u003e2\u003c/em\u003e\u003c/sup\u003e\u003cem\u003e= Pearson Correlation coefficient, DRE= Digital rectal exam, PSA= Prostate specific antigen\u003c/em\u003e\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-2121937/v1/6585afee9aa0180cb8db23a2.png"},{"id":35925776,"identity":"fa5bf500-1081-4b5d-a3a5-a62884bbc3ed","added_by":"auto","created_at":"2023-04-18 09:45:22","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":504719,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-2121937/v1/da79738a-8fd7-4298-a544-8f1c7d69d7fa.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Effect of digital rectal examination on prostate specific antigen levels among patients with lower urinary tract symptoms in Uganda","fulltext":[{"header":"Background","content":"\u003cp\u003eProstatic malignancy is the second commonest cancer and major contributor to mortality among males in Sub-Saharan Africa, ranking fifth globally (\u003cspan class=\"CitationRef\"\u003e1\u003c/span\u003e). Over the last 20 years, in sub-Saharan Africa alone, there has been increase in diagnosis and mortality arising from several malignancies attributed to change in way of life, behaviors and environment (\u003cspan class=\"CitationRef\"\u003e2\u003c/span\u003e). In Uganda prostate cancer rate was reported to be 65.0 per 100,000, with a mortality-to-incidence ratio of 71% (\u003cspan class=\"CitationRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eProstate-specific antigen (PSA) is a screening investigation for cancer of the prostate and also gives information about the extent of the malignancy, as well as the disease trajectory during monitoring and therapy (\u003cspan class=\"CitationRef\"\u003e4\u003c/span\u003e). Once a year, men at the age of 50 or more should visit a urologist to have a clinical examination of the prostate through the rectum in addition to prostate specific antigen laboratory investigation (\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e). For those with a family history of prostate cancer or an afro descent, this check should start at the age of 40.(\u003cspan class=\"CitationRef\"\u003e5\u003c/span\u003e). Total prostate specific antigen above 4 ng/ml is currently considered pathologic, and values above 10 ng/ml are strongly suggestive of cancer (\u003cspan class=\"CitationRef\"\u003e6\u003c/span\u003e). Concepts including age cutoff, PSA velocity and free PSA were created to improve PSA sensitivity (\u003cspan class=\"CitationRef\"\u003e7\u003c/span\u003e). PSA is known to be a prostate-specific marker but procedures such as DRE, colonoscopy and prostate biopsy can change PSA levels (\u003cspan class=\"CitationRef\"\u003e8\u003c/span\u003e). PSA levels are thought to rise in direct proportion to the procedure\u0026apos;s stimulation intensity (\u003cspan class=\"CitationRef\"\u003e9\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003eThe serum PSA test and digital rectal examination (DRE) allow doctors to detect prostate cancer when it is still in its early stages (\u003cspan class=\"CitationRef\"\u003e10\u003c/span\u003e). Studies have revealed that DRE causes an elevation in serum PSA levels (\u003cspan class=\"CitationRef\"\u003e11\u003c/span\u003e). Following DRE, the PSA starts to raise at 10 munities, reaches its highest level at 1 hour and the effect can last up to 3 weeks (\u003cspan class=\"CitationRef\"\u003e12\u003c/span\u003e). This rise following DRE may be mistaken for the rise associated with malignancy of the prostate resulting in miss-diagnosis when PSA is used to screen (\u003cspan class=\"CitationRef\"\u003e10\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e13\u003c/span\u003e). For this reason, it has been recommended to perform PSA before DRE (\u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e). Currently, both digital rectal examination and prostate specific antigen done at the same time are recommended for prostate cancer screening because this technique offers up to 75% diagnostic sensitivity for prostate carcinoma (\u003cspan class=\"CitationRef\"\u003e14\u003c/span\u003e, \u003cspan class=\"CitationRef\"\u003e15\u003c/span\u003e).\u003c/p\u003e\n\u003cp\u003ePSA testing, digital rectal exam (DRE), and prostate biopsy are the cornerstone of prostate cancer screening (\u003cspan class=\"CitationRef\"\u003e15\u003c/span\u003e). Most clients in our setting come to urology clinic as referrals from primary physicians when DRE has been done. This pauses a challenge in interpretation of PSA test values with potential for many falsely positive results resulting in unnecessary invasive procedures, pain, erectile dysfunction, and urinary incontinence, as well as prostate cancer over diagnosis and overtreatment. There has been a significant knowledge gap regarding the extent to which DRE increases PSA levels and whether this change could lead to DRE being withheld before PSA measurement in prostate cancer screening. This study was aimed at assessing the extent of PSA change following DRE among men above 40 years presenting with lower urinary tract symptoms (LUTS).\u003c/p\u003e\n"},{"header":"Methods","content":"\u003cp\u003e\u003cstrong\u003eStudy design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study was a single Centre prospective longitudinal study\u003c/p\u003e \u003cp\u003e \u003cb\u003eStudy Setting.\u003c/b\u003e \u003c/p\u003e \u003cp\u003eThe study was done at Ishaka Adventist Hospital (IAH) which is located in Ishaka municipality Bushenyi district approximately 60 kilometers (39 miles) West of Mbarara district in western Uganda. IAH has two surgeons running the surgical clinic, it treats 50 patients seeking urology care in a month. Patients were reviewed from the outpatient department from Monday to Friday. The hospital has a fully functional laboratory that caters for PSA testing and theater services for prostate biopsy.\u003c/p\u003e \u003cdiv id=\"Sec4\" class=\"Section2\"\u003e \u003ch2\u003eStudy Population\u003c/h2\u003e \u003cp\u003eThe study targeted men above 40 years in Bushenyi district, that presented with lower urinary tract symptoms (LUTS) to the outpatient clinic during the period of the study.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eSample Size Determination\u003c/h3\u003e\n\u003cp\u003eDaniel formula (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e); n\u0026thinsp;=\u0026thinsp;Z\u003csub\u003e1\u0026minus;α/2\u003c/sub\u003e\u003csup\u003e2\u003c/sup\u003ep(1-p) / d\u003csup\u003e2\u003c/sup\u003e was used to determine the sample size, where n\u0026thinsp;=\u0026thinsp;estimated minimum sample size required, P\u0026thinsp;=\u0026thinsp;proportion of characteristic in a sample, Z\u003csub\u003e1\u0026minus;α/2\u003c/sub\u003e=1.96 (for 95% Confidence interval), e\u0026thinsp;=\u0026thinsp;Margin of error set at 5%. Using findings by (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e) who reported the incidence of cancer of the prostate to be 6.4% in Uganda, n= (1.96)\u003csup\u003e2\u003c/sup\u003e x 0.064 (1-0.064)/ (0.05)\u003csup\u003e2\u003c/sup\u003e, n\u0026thinsp;=\u0026thinsp;92. To increase the internal validity of study and catering for non-responders, the calculated sample size was increased by 10% giving an estimated sample size of 102.\u003c/p\u003e\n\u003ch3\u003eSampling Technique\u003c/h3\u003e\n\u003cp\u003eConsecutive recruitment was used until the desired sample size was achieved. Male patients who presented to the surgical outpatient department with LUTS were enrolled following informed consent.\u003c/p\u003e\n\u003ch3\u003eEligibility Criteria\u003c/h3\u003e\n\u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003eInclusion criteria\u003c/h2\u003e \u003cp\u003eMen above 40 years with LUTS at surgical outpatient department who consented to participate in the study\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec9\" class=\"Section2\"\u003e \u003ch2\u003eExclusion criteria\u003c/h2\u003e \u003cp\u003ePatients with indwelling urethral catheters were excluded in addition to those with a history of prostatectomy, those who had undergone trans-rectal ultrasound scan over the previous one month and those with a history of urogenital trauma.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eData Collection Procedure And Psa Measurement\u003c/h3\u003e\n\u003cp\u003e All patients that were eligible for the study signed a Kampala international university Research and Ethics committee (KIU-REC) format consent form after explaining to them the details of the consent. After consenting, a questionnaire that was pretested and interviewer administered was filled for each patient that consented. After filling the questionnaire, a sample of Venus blood was drawn aseptically for PSA analysis. A digital rectal exam was done and then 1-hour later, another sample for PSA testing was drawn and all samples were analyzed in the hospital laboratory. Patient\u0026rsquo;s venous blood was collected in a sterile Vacutainer tube without anticoagulant and centrifuged for serum separation and total serum PSA was measured using, i chroma machine (i-CHROMA\u0026trade;). The same machine was used for all samples.\u003c/p\u003e \u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003eDigital rectal examination\u003c/h2\u003e \u003cp\u003ePatient was positioned in the left lateral position with the left leg extended and the right flexed at the knee in the doctor\u0026rsquo;s examination room with adequate privacy. A double gloved index finger was gently introduced into the rectum via the anal opening after lubricating with K-y jelly. Using the index finger, the prostate was palpated, and assessment made as to whether it is enlarged or not, symmetrical or asymmetrical, nodular or non-nodular, soft, firm or hard, tender or non-tender, palpable groove or obliterated groove, with free mucosa or fixed mucosa. The findings were documented after cleaning the perianal area.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eQuality Control\u003c/h3\u003e\n\u003cp\u003eInclusion and exclusion criteria were strictly adhered to. The research team was instructed on how to administer the questionnaire. The data collection tool was cross checked for completeness. The same equipment was used to measure PSA for all samples. Controls were run regularly.\u003c/p\u003e \u003cp\u003e \u003cb\u003eData analysis and presentation\u003c/b\u003e \u003c/p\u003e \u003cp\u003eData was coded and entered in excel sheet, and analyzed using SPSS version 22. Frequencies and percentages were used to describe categorical variables while mean and standard deviation were used for continuous variables. To determine the change in PSA following DRE, the PSA values for the patients before and after DRE were entered as continuous variables. Using the paired samples T test procedure, the mean difference between the pre and post DRE PSA level was determined with the corresponding standard deviation and p value. If the corresponding p value was less or equal to 0.05, the difference was considered significant. The values of pre and post DRE PSA were compared for each patient to determine if the post DRE PSA would have affected (changed) the clinical decision in order to assess the clinical significant of the PSA changes.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eDuring the study period, 114 patients presented to the study centre with a history of lower urinary tract symptoms. 10 of the 114, had a urethral catheter inserted before arrival to the study centres. 2 of the remaining had prostatectomy in the previous years. PSA was done for 102 patients as shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003eSocial-demographic characteristics of the study participants\u003c/h2\u003e \u003cp\u003eIn this study, the mean age of the participants was 61.85\u0026thinsp;\u0026plusmn;\u0026thinsp;12.73 years and the mean BMI was 24.27\u0026thinsp;\u0026plusmn;\u0026thinsp;4.17. Majority of the participants were from the rural areas (80.4%), married (92.2%), with maximum level of education as primary (60.8%) and peasants (64.7%) as shown in Table \u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eshows the social-demographic characteristics of the study participants.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCharacteristic\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eStatistic\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eMean\u0026thinsp;=\u0026thinsp;61.85, SD\u0026thinsp;=\u0026thinsp;12.73, Min\u0026thinsp;=\u0026thinsp;40, Max\u0026thinsp;=\u0026thinsp;95\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBody mass Index (BMI)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003eMean\u0026thinsp;=\u0026thinsp;24.27, SD\u0026thinsp;=\u0026thinsp;4.17, Min\u0026thinsp;=\u0026thinsp;14.53, Max\u0026thinsp;=\u0026thinsp;38.57\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e\u003cb\u003eFrequency\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e\u003cb\u003ePercentage\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eAge Category\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e40\u0026ndash;50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e23\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e22.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e51\u0026ndash;60\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e26\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e25.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e61\u0026ndash;70\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e26\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e25.5\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e71\u0026ndash;80\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e21\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e20.6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e81\u0026ndash;100\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBMI Category\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e14.53\u0026ndash;18.50\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e18.51\u0026ndash;29.99\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e90\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e88.2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e30.00- 38.57\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eResidence\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eRural\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e82\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e80.4\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUrban\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e20\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e19.6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMarital status\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMarried\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e94\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e92.2\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSingle\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eWindowed\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDivorced\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e1.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eEducation Level\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePrimary\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e62\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e60.8\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSecondary\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e22\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e21.6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTertiary\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e16\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e15.7\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eNo Education\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eOccupation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePeasant\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e66\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e64.7\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBusiness\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e18.6\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eFormal Employment\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e14\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e13.7\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDriver\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003ctfoot\u003e \u003ctr\u003e\u003ctd colspan=\"3\"\u003e\u003cem\u003eSD\u0026thinsp;=\u0026thinsp;Standard deviation, Min\u0026thinsp;=\u0026thinsp;minimum, Max\u0026thinsp;=\u0026thinsp;Maximum, BMI\u0026thinsp;=\u0026thinsp;Body mass Index.\u003c/em\u003e\u003c/td\u003e\u003c/tr\u003e \u003c/tfoot\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec15\" class=\"Section2\"\u003e \u003ch2\u003eEffect of Digital rectal examination on PSA levels\u003c/h2\u003e \u003cp\u003eIn this study, it was noted that in some patients, the PSA after DRE was lower than that done before the rectal exam, yet in others it remained the same or increased as shown in Table \u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eShowing the type of PSA change observed\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eChange type\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eFrequency\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePercentage\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eMean Pre DRE PSA\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eMean for post DRE PSA\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eMean PSA change\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDecrease\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e29\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e28.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e4.86\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e4.31\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.55\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSame\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e19\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e18.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e7.25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e7.25\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.00\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eIncrease\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c2\"\u003e \u003cp\u003e54\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c3\"\u003e \u003cp\u003e52.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c4\"\u003e \u003cp\u003e4.62\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c5\"\u003e \u003cp\u003e5.70\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e1.08\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003eOn plotting the means of PSA in each age category both the mean pre and post DRE PSA ware seen to increase with age. We observed that the mean Post DRE PSA was lower than the pre-DRE in patients who had a PSA below 6 ng/ml as shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eThe paired samples T test revealed that there was a small mean increase in PSA following DRE (0.40 ng/ml). This increase was not statistically significant (p\u0026thinsp;=\u0026thinsp;0.061). Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e shows the result of the paired samples T test. The findings of the paired samples T test were supported by a scatter plot which revealed a perfect correlation (R\u003csup\u003e2\u003c/sup\u003e\u0026thinsp;=\u0026thinsp;0.975) between the pre and post DRE PSA as shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eshows the result of the paired samples T test.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"3\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCharacteristic\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003ePre DRE PSA\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003ePost DRE PSA\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e5.18\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e5.59\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStandard deviation\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e12.86\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e13.35\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMean difference\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e-0.40\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eStandard error of the mean difference\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e0.21\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eConfidence interval of the mean difference\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e-0.817 to 0.020\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eP value of mean difference\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colspan=\"2\" nameend=\"c3\" namest=\"c2\"\u003e \u003cp\u003e\u003cb\u003e0.061\u003c/b\u003e\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cdiv id=\"Sec16\" class=\"Section3\"\u003e \u003ch2\u003eDRE\u0026thinsp;=\u0026thinsp;Digital rectal exam, PSA\u0026thinsp;=\u0026thinsp;Prostate specific antigen\u003c/h2\u003e \u003cp\u003e \u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec17\" class=\"Section3\"\u003e \u003ch2\u003eR\u003csup\u003e2\u003c/sup\u003e\u0026thinsp;=\u0026thinsp;Pearson Correlation coefficient, DRE\u0026thinsp;=\u0026thinsp;Digital rectal exam, PSA\u0026thinsp;=\u0026thinsp;Prostate specific antigen\u003c/h2\u003e \u003cp\u003eIt was also observed that the number of patients whose clinical decision would be affected (changed) by the PSA measured after DRE was 3 (2.9%, CI\u0026thinsp;=\u0026thinsp;0.0%-6.9%) if cutoff was 3ng/ml and 2 (2.0%, CI\u0026thinsp;=\u0026thinsp;0.0%-4.9%) at a cutoff of 4ng/ml. The confidence intervals in both scenarios included 0.0%, suggesting that there would be no significant effect on the clinical decision if the PSA was done post DRE as shown in Table \u003cspan refid=\"Tab4\" class=\"InternalRef\"\u003e4\u003c/span\u003e.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab4\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 4\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eshows the impact of change in PSA on Clinical decision\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"5\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eCutoff\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eEffect on decision\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eFrequency\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003epercentage\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003e95% CI\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e3.00 ng/ml\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo change in decision\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e99\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e97.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e93.1\u0026ndash;100.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eChange in decision\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.0-6.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\" morerows=\"1\" rowspan=\"2\"\u003e \u003cp\u003e4.00 ng/ml\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eNo change in decision\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e100\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e98.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e95.1\u0026ndash;100.0\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003eChange in decision\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e2.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e0.0-4.9\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Discussion","content":"\u003cp\u003eThere has been insufficient data about the effect of DRE on PSA in men above 40 years with LUTS in Uganda and sub-Sahara Africa in general. Despite DRE and PSA being the cornerstones of cancer of prostate screening their interplay has not been studied in our setting. Most studies have been performed in white population thus making this the first study to assess the effect of DRE on PSA in Africa.\u003c/p\u003e \u003cp\u003eOur study showed that 29.5% (29 patients) of the study participants had a decrease in PSA with an average decrease of 0.55 ng/ml. In 18.6% (19 patients) there was no change in PSA. 52.9% (54 patients) had increase in PSA with an average increase of 1.08 ng/ml. The above results confirm that DRE affects PSA values, however the decrease in the PSA values after DRE seen in 29.5% of the participants could be explained by the acceptable margin of error of the equipment.\u003c/p\u003e \u003cp\u003eFurther analysis revealed that DRE slightly increased the level of PSA with a mean difference of 0.4 ng/ml however this change was statically insignificant with a p value of 0.061. This was similar to a study done in Nigeria by Eshiobo (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) who observed that DRE caused an increase in PSA of 8 to 13% however this was statistically insignificant. In a study that enrolled 199 men in the USA, it was noted that the DRE caused a non-significant increase in PSA (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eContrally to our findings, significant changes in PSA were seen by Crawford et al (\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e) in some males with pre-DRE PSA levels under 4.0 ng/mL, however, the clinical significance of the changes were not reported. Chybowski \u003cem\u003eet al\u003c/em\u003e (\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e) evaluated the effects of DRE in 71 males who had prostatic diseases and 72 controls and noted that some men with initial PSA values up to 4.0 ng/mL presented a statistically significant increase of serum PSA, however the changes were not clinically significant as was seen in this study.\u003c/p\u003e \u003cdiv id=\"Sec19\" class=\"Section2\"\u003e \u003ch2\u003eStudy Limitations\u003c/h2\u003e \u003cp\u003eThis study was hospital based, assessing males who already had lower urinary tract symptoms which to a large extent, may have influenced the values of PSA in this study population. There is need for a community based study in these rural areas in preparation for properly regulated screening programs in sub Saharan African countries.\u003c/p\u003e \u003c/div\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThis study revealed that the change in PSA following DRE was not significant both statistically and clinically. Therefore DRE can be used in screening and clinical assessment for cancer of the prostate without fear that it would interfere with PSA value interpretation and patient management.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003ePSA= Prostate specific antigen, DRE: Digital rectal examination, LUTS= Lower urinary tract symptoms, CI= Confidence interval.\u003c/p\u003e\n"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthical considerations and consent:\u0026nbsp;\u003c/strong\u003eAll methods were carried out in accordance with relevant guidelines and regulations. The study was approved by the Kampala international university research and ethics committee reference number \u003cstrong\u003eUG-REC-023/202207.\u003c/strong\u003e A voluntary and non-coercive recruitment was sought leading to signing of a written informed consent form following thorough explanation to the participant about the study.\u0026nbsp;All the participants provided written informed consent. The Uganda National Guidelines for currying out research during the COVID- 19 pandemic (UNCST, 2020) were also followed.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication:\u0026nbsp;\u003c/strong\u003eThe patient data was anonymised, no patient identifying characteristics are submitted for publication.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials:\u0026nbsp;\u003c/strong\u003eData is available upon request. Requests should be sent to BM Via
[email protected] \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e: The authors declare that they have no conflict of interest\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSources of funding\u003c/strong\u003e: This study did not receive any specific grant from funding agencies in public, commercial, or not for profit sectors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthor contribution: BM\u0026nbsp;\u003c/strong\u003ewas the principle investigator, conceived and designed the study, collected data, analysed data and wrote the draft of the manuscript. \u003cstrong\u003eJM\u0026nbsp;\u003c/strong\u003eparticipated in data analysis, discussion of results and critically revised the manuscript, \u003cstrong\u003eTH, FKK and MJO\u0026nbsp;\u003c/strong\u003eparticipated in discussion of results and critically revised the manuscript, \u003cstrong\u003eBN and XFO\u0026nbsp;\u003c/strong\u003esupervised the work, critically revised the manuscript and all authors approved the final paper.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements:\u0026nbsp;\u003c/strong\u003eWe acknowledge all patients that accepted to participate in this study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eGuarantor:\u0026nbsp;\u003c/strong\u003eBM\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eMbugua RG, Oluchina S, Karanja S. Prostate cancer awareness and screening among men in a rural community in Kenya: a cross-sectional study. African J Urol. 2021;27(1). \u003c/li\u003e\n\u003cli\u003eEngel JC, Palsdottir T, Aly M, Egevad L, Eklund M, Nordstr\u0026ouml;m T, et al. Lower urinary tract symptoms ( LUTS ) are not associated with an increased risk of prostate cancer in men 50 \u0026ndash; 69 years with PSA \u0026ge; 3 ng / ml. Scand J Urol [Internet]. 2020;54(1):1\u0026ndash;6. Available from: https://doi.org/10.1080/21681805.2019.1703806\u003c/li\u003e\n\u003cli\u003eOkuku F, Orem J, Holoya G, Boer C De, Thompson CL, Matthew. Prostate Cancer Burden at the Uganda Cancer Institute. Am Soc Clin Oncol. 2015;(March). \u003c/li\u003e\n\u003cli\u003eLewis DD, Cropp CD. The impact of African ancestry on prostate cancer disparities in the era of precision medicine. Genes (Basel). 2020;11(12):1\u0026ndash;28. \u003c/li\u003e\n\u003cli\u003eSoares SCM, De Camargo Cancela M, Migowski A, De Souza DLB. Digital rectal examination and its associated factors in the early detection of prostate cancer: A cross-sectional population-based study. BMC Public Health. 2019;19(1):1\u0026ndash;11. \u003c/li\u003e\n\u003cli\u003eLittle B, Ho KJ, Gormley G, Young M. PSA testing in general practice. Prosate cancer prostatic Dis. 2003;6(2):154\u0026ndash;8. \u003c/li\u003e\n\u003cli\u003eNordstrom T, Akre O, Aly M et al. PSA Density in the diagnostic alogrithm of prosrare cancer. Prostate cancer prostatic dis. 2018;21:57\u0026ndash;63. \u003c/li\u003e\n\u003cli\u003eIrekpita E, Owobu C, Aigbe E, Obasikene G, Igbe A. Assessment of DRE and PSA as Diagnostic and Screening Tools for Carcinoma of the Prostate in Rural Nigeria. 2014;19(3):53\u0026ndash;8. \u003c/li\u003e\n\u003cli\u003eKim JS, Ryu J, Kim JW, Hwang EC, Jung S Il, Kang TW, et al. Prostate-Specific Antigen fluctuation : what does it mean in diagnosis of prostate cancer ? _______________________________________________. 2015;41(2):258\u0026ndash;64. \u003c/li\u003e\n\u003cli\u003ePrcic A, Begic E. Usefulness of Total PSA Value in Prostate Diseases Diagnosis. 2016;24(3):156\u0026ndash;61. \u003c/li\u003e\n\u003cli\u003eAl Rumaihi K, Al Jalham K, Younes N, Majzoub AA, Shokeir AA. The role of an abnormal prostate-specific antigen level and an abnormal digital rectal examination in the diagnosis of prostate cancer: A cross-sectional study in Qatar. Arab J Urol. 2013;11(4):355\u0026ndash;60. \u003c/li\u003e\n\u003cli\u003eKoo KC, Park SU, Kim KH, Rha KH, Hong SJ, Yang SC, et al. Predictors of survival in prostate cancer patients with bone metastasis and extremely high prostate-speci fi c antigen levels. Prostate Int [Internet]. 2015;3(1):10\u0026ndash;5. Available from: http://dx.doi.org/10.1016/j.prnil.2015.02.006\u003c/li\u003e\n\u003cli\u003eHirachand S, Ums D, Pradhanang S, Acharya S. Study of prostatic pathology and its correlation with prostate specific antigen. 2017;7:1074\u0026ndash;7. \u003c/li\u003e\n\u003cli\u003eNaji L, Randhawa H, Sohani Z, Dennis B, Lautenbach D, Kavanagh O, et al. Digital rectal examination for prostate cancer screening in primary care: A systematic review and meta-analysis. Ann Fam Med. 2018;16(2):149\u0026ndash;54. \u003c/li\u003e\n\u003cli\u003eIrekpita E, Achor GO, Alili U. Assessment of the value of the different variants of abnormal digital rectal examination finding in predicting carcinoma of the prostate: a preliminary report of a two-center study. African J Urol. 2020;26(1). \u003c/li\u003e\n\u003cli\u003eDaniel W. Biostatistics: A foundation for analysis in Health sciences. 7th Editio. Sons J wiley and, editor. New York; 1999. \u003c/li\u003e\n\u003cli\u003eKatongole P, Sande OJ, Yusuf M, Joloba M, Reynolds SJ, Niyonzima N. Clinical characteristics and primary management of patients diagnosed with prostate cancer between 2015 and 2019 at the Uganda Cancer Institute. PLoS One [Internet]. 2020;15(10 October):6\u0026ndash;12. Available from: http://dx.doi.org/10.1371/journal.pone.0236458\u003c/li\u003e\n\u003cli\u003eWilliam JC, Smith D s, Ratliff T, Dodds KM, Coplen DE, Yuan J, et al. Measuremt of PSA in serum as a screening test for prostate cancer. N Engl J Med. 1991;324(17):1156\u0026ndash;61. \u003c/li\u003e\n\u003cli\u003eCrawford DE, Schutz, Clejan MJ, Drago S, Resnick J, Chodak MI, et al. The effect of DRE on PSA levels. Jaun Am Med Assoc. 1992;267(16):2227\u0026ndash;8. \u003c/li\u003e\n\u003cli\u003eChybowski FM, Bergstralh E j, Oesterling JE. The Effect of DRE on serum PSA concetration: Results of a randomised study. jounal Urol. 1992;148(1):83\u0026ndash;6. \u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"
[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Prostate specific antigen, Digital rectal exam, Prostate cancer","lastPublishedDoi":"10.21203/rs.3.rs-2121937/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-2121937/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eIntroduction\u003c/p\u003e \u003cp\u003eProstatic cancer is a major contributor to mortality among men globally. Prostate-specific antigen (PSA) is a screening investigation for cancer of the prostate. The combination of serum PSA and digital rectal examination (DRE) allows early detection of prostate cancer. Studies have revealed that DRE causes an elevation in serum PSA levels. This rise following DRE may be mistaken for the rise associated with malignancy. Most clients in our setting come to the urology clinic as referrals from primary physicians when DRE has been done. There is a significant knowledge gap regarding whether the PSA change following DRE is significant enough to warrant withholding PSA measurement in these patients that come after having DRE; the reason this study was done.\u003c/p\u003e \u003cp\u003eMethods\u003c/p\u003e \u003cp\u003eThis was a single centre prospective longitudinal study done at Ishaka Adventist hospital in which an interviewer administered questionnaire was filled for each patient that consented. After filling the questionnaire, a venous blood sample was drawn, DRE done and 1-hour later, another blood sample drawn. Total PSA was measured for both samples and data analyzed using SPSS version 22.\u003c/p\u003e \u003cp\u003eResults\u003c/p\u003e \u003cp\u003eData for 102 participants was analyzed, whose mean age was 61.85\u0026thinsp;\u0026plusmn;\u0026thinsp;12.73 years. The paired samples T test revealed a small mean increase in PSA following DRE (0.40 ng/ml) that was not significant (p\u0026thinsp;=\u0026thinsp;0.061). The number of patients whose clinical decision would be affected (changed) by the PSA measured after DRE was 3 (2.9%, CI\u0026thinsp;=\u0026thinsp;0.0%-6.9%) if cutoff was 3 ng/ml and 2 (2.0%, CI\u0026thinsp;=\u0026thinsp;0.0%-4.9%) at 4 ng/ml cutoff. The confidence intervals in both scenarios included 0.0%, suggesting that there would be no significant effect on the clinical decision if the PSA was done post DRE.\u003c/p\u003e \u003cp\u003e \u003cb\u003eConclusion\u003c/b\u003e. DRE can be used in screening and clinical assessment of prostate cancer without fear of interfering with PSA result interpretation and patient management.\u003c/p\u003e","manuscriptTitle":"Effect of digital rectal examination on prostate specific antigen levels among patients with lower urinary tract symptoms in Uganda","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2022-10-12 14:24:35","doi":"10.21203/rs.3.rs-2121937/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"
[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"8424e111-3420-4aeb-b5fb-3ad87bcb42c4","owner":[],"postedDate":"October 12th, 2022","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2023-04-18T09:45:15+00:00","versionOfRecord":[],"versionCreatedAt":"2022-10-12 14:24:35","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-2121937","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-2121937","identity":"rs-2121937","version":["v1"]},"buildId":"ApUGefWb6u5IBVtyqm6d5","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}
Text is read by the "Ask this paper" AI Q&A widget below.
Extraction quality varies by source — PMC NXML preserves structure
cleanly, OA-HTML may include some navigation residue, and OA-PDF can
have broken hyphenation. The publisher copy
(via DOI)
is the canonical version.