Prospective Study to Compare the Efficacy of Lower Urinary Tract Symptoms Visual Score versus International Prostate Symptom Score for Evaluating Men With Lower Urinary Tract Symptoms

Prospective Study to Compare the Efficacy of Lower Urinary Tract Symptoms Visual Score versus International Prostate Symptom Score for Evaluating Men With Lower Urinary Tract Symptoms | 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 Prospective Study to Compare the Efficacy of Lower Urinary Tract Symptoms Visual Score versus International Prostate Symptom Score for Evaluating Men With Lower Urinary Tract Symptoms Ashwath Venkataramana VH, Shivakumar V, Ramaiah Keshavamurthy This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-4705854/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 Aim and Objective The number of men presenting with lower urinary tract symptoms (LUTS) to our institute’s outpatient department (OPD) is exceedingly high. Because most of the patients who visit the OPD are illiterate or undereducated, using advanced patient-based symptom measures such as the gold standard International Prostate Symptom Score (IPSS) is difficult. This calls for a less complicated grading scheme. Thus, our objective in this study is to evaluate the effectiveness of our institute’s lower urinary tract symptoms visual score (LUTS-V), a condensed score based on a visual scoring method that Silva et al. described. Material and Methods Silva et.al. [ 8 ] developed LUTS-V, a modified form of the visual prostate symptom score (VPSS). We prospectively instructed patients presenting with LUTS to the OPD to fill their LUTS-V and IPSS scores at their first OPD visit. We conducted our study over a period of eight months at the Institute of Nephro Urology, a tertiary center in Bangalore, Karnataka, India. We expressed data as medians and ranges, or absolute values and fractions. We tested the overall IPSS and LUTS-V scores for agreeability using Bland–Altman analysis, Spearman’s correlation plot, and the Pearson correlation coefficient. We evaluated diagnostic properties (criteria validity) in terms of sensitivity, specificity, and accuracy. We used uroflowmetry as a reference standard. We measured the time (in seconds) necessary for completion of each IPSS and LUTS-V questionnaire. We considered p < 0.05 as statistically significant. Result We included 280 patients in the study, ranging in age from 22 to 80 years with a mean age of 64.61 years. The patient cohort had a mean education of 7.41 years. Education status was inversely related to age according to the Pearson correlation coefficient (r = − 0.7122, p < .00001). We found that 3.2% of patients had mild symptoms, 86% had moderate symptoms, and 66.01% had severe symptoms. LUTS-V ranged from 1 to 12. We divided the patients into mild, moderate, and severe symptomatic groups and compared them with similar groups with the IPSS. Receiver operating characteristic (ROC) analysis gave us a cutoff of 4 points of LUTS-V for mild symptom and 9 points for severe symptoms. A cutoff less than 4 for mild symptoms yielded sensitivity of 73.68%, specificity of 99.23%, and accuracy of 97.5% (p = 0.001), whereas a cutoff more than 9 points for severe symptoms had high sensitivity of 95.35%, specificity of 83.07%, and accuracy of 86.3% (p = 0.0001). The patients took an average of 195 seconds to complete the IPPS, and many required help in understanding the IPSS score, whereas they took an average of 60.89 sec to complete the LUTS-V (p < 0.001). Conclusion LUTS-V is a simplified tool that has adequate comparability to the gold standard IPSS, which patients with a poor educational background can easily interpret. Figures Figure 1 Figure 2 Figure 3 Introduction LUTS comprises a variety of urinary symptoms that can be detrimental to affected individuals’ quality of life. It is frequently associated with other clinical conditions such as diabetes, neurological disorders, and erectile dysfunction [ 1 ]. Various guidelines advise evaluating males with LUTS by initially using a validated symptom questionnaire [ 2 ]. Patient-reported outcome assessments are useful tools for characterizing symptom burden and health-related quality of life, and they play an increasing role in clinical decision-making [ 3 ]. At our institution—a tertiary center mostly serving the economically disadvantaged segment of the population—patients presenting with LUTS comprise a sizable fraction of daily OPD cases. Because of this, the vast majority of patients that come into our institution have lower levels of education. We assess men with LUTS using the IPSS, the most commonly used questionnaire [ 4 ]. Patients with a lower education typically experience difficulty in accurately completing the IPSS [ 5 ]. We faced three problems while using the IPSS at our OPD. First, the majority of the patients were illiterate in the English language. Therefore, we had to translate the IPSS into regional languages using different scripts. Some of the information was lost in the translation, or we could not translate it to provide the exact statement as the IPSS intended. For example, we found it difficult to translate “presence of symptoms less than 1 in 5 times” and differentiate it from “presence of symptoms less than half the times.” Second, those who were illiterate could not use the IPSS. We tried translating it and making the patients understand it in the form of systematic interviews. However, we noted that this led to bias because most patients could not differentiate their symptoms among the various groups. Third, arriving at a meaningful score was time-consuming, and many clinicians avoided calculating patient-based scores. Thus, we needed a new simplified score to evaluate the presence of LUTS, so we used Van der Walt et al.’s VPSS. We used pictograms in this score for three symptoms, that is, frequency, nocturia, and weak stream, along with their impact on quality of life. The VPSS significantly correlated with the IPSS, and patients could complete it with no assistance. The original VPSS contained a pictorially depicted “stream of urine” with values ranging from 1 to 5. Using the VPSS, we overcame the barriers pertaining to language and level of education. This scoring system was relatively easy to interpret and complete especially because of the lack of mathematical calculations involved in the score [ 6 ]. However, the VPSS had a few limitations. A recurring theme in our research was the lack of clarity among many subjects regarding the symptom description used to assess nocturia and quality of life. Many patients objected to the VPSS’s black pictogram background [ 7 ]. We suggested some improvements, such as clearer images for the pictograms that depicted urinary frequency and nocturia and images that depicted urinary urgency. Additionally, we noted that the VPSS gave a daytime micturition of five times a score of 5, which may falsely increase the overall score, whereas the IPSS gave a score of 5 for urgency ( urinating once every two hours). Silva et al. addressed some of the drawbacks in their study on LUTS-V by developing a new simplified score for assessing LUTS in men [ 8 ]. They revised the VPSS scoring system by resizing the images, altering the pictogram’s sequence and pattern, adding the possibility of nocturia absence, and grouping daytime frequencies. Additionally, they made conceptual changes and reduced the number of answers for the questions about daytime and nocturnal frequency from seven to four and the number of answers for the questions concerning quality of life from seven to three (Fig. 1 ). Our institution agreed that we use this new simplified VPSS and test its efficacy against the IPSS in evaluating the symptoms of patients who presented with LUTS. Methodology We obtained approval for our study from our institutional review board (No. INU/RRC/04/2023-24). We conducted a prospective non-interventional study over a period of eight months at the Institute of Nephro Urology in Bangalore, India. We included adult men of all ages who presented with LUTS and were mentally capable of understanding the instructions and providing a valid consent to participate in the study. We excluded patients who had undergone surgical or medical treatment for benign prostatic hyperplasia (BPH) or urethral stricture, had systemic neurological disease, had received chemotherapy owing to malignancy, had a history of pelvic radiotherapy, and who had received a diagnosis of neurogenic bladder. We needed 280 or more measurements or surveys to obtain a confidence interval of 95% so that the real value fell within ± 5% of the measured or surveyed value. We maintained a margin of error of 5% in the above calculation. We gave patients both the scores at their initial presentation in the OPD and asked them to complete both the LUTS-V (Fig. 1 ) and the IPSS surveys at baseline. We conducted uroflowmetry at the initial presentation. The patients completed the self-administered questionnaires in a private, quiet room. They could ask for a designated researcher’s assistance in case of difficulty understanding or completing the surveys. Illiterate men completed the questionnaires in the form of a structured interview. We gave additional directions for the IPSS when required. We expressed data as medians and interquartile ranges, or as absolute values and fractions. We used the Mann–Whitney U test to compare continuous variables and the chi-square and Fisher’s exact tests to compare categorical variables. We used the total IPSS and LUTS-V for each subject to determine the agreement between the two instruments using Bland–Altman analysis and Spearman’s correlation plot. We used a plotted ROC curve to evaluate the diagnostic accuracy and the best cutoff point for LUTS-V. We described diagnostic properties (criteria validity) in terms of sensitivity, specificity, and accuracy. We used uroflowmetry as a reference standard for the construct validity analysis of LUTS-V. We measured the time (in minutes) necessary to complete each questionnaire. We considered all tests a p < 0.05 as statistically significant. Results We enrolled 280 patients in our study after obtaining their informed consent. Their mean age was 64.61 years (SD = 11.38). The majority of the patients (47.14%) were in the age group 60–70 years. Patients older than 70 years comprised 33% of the study subjects, followed by the 50–60 years group (10%). Patients younger than 50 years comprised only about 6% of the study population (Figure 2). In analyzing the education status (Table 1), we found that 50 of the 280 patients (17%) were illiterate; 127 patients (45%) had attended primary school, considered as one to four years of education; and 63 patients (22.5%) had attended school up to middle school, that is, five to eight years of education. Only 40 patients (14%) had attained an education of high school level (more than eight years of school). We also found a statistically significant age-dependent reduction in the education status. Mean years of schooling for patients younger than 60 years was 9.7 years, whereas mean years of schooling for patients older than 60 years was only 4.54 school years (p < 0.0001). Table 1: Education status of patient population. LITERACY STATUS FREQUENCY PERCENTAGE ILLITERATE 50 17% PRIMARY SCHOOL 127 45% MID SCHOOL 63 22.50% HIGH SCHOOL 40 14.28% MEAN YEARS OF EDUCATION FOR PATIENTS AGED 60 YEARS 4.54 The mean IPSS of the patient population was 16.82 (Table 2). Most of them (185 = 66%) presented to us only when the symptoms became severe, whereas 86 patients (30.71%) had moderate symptoms. Only nine patients (3.2%) had mild symptoms. All but 18 patients requested assistance while filling in the IPSS form. Table 2: International Prostate Symptom Score distribution of patient population. IPPS GRADE FREQUENCY PERCENTAGE MILD (0-7) 9 3.20% MODERATE(8-19) 86 30.71% SEVERE(20-35) 185 66.01% MEAN 16.8209 We then compared the LUTS-V to the IPSS. We found the LUTS-V had a statistically significant positive correlation with the IPSS on applying Pearson’s correlation coefficient (r = 0.54, p < 0.001). We plotted ROC curves of the LUTS-V regarding the severity of the symptoms, keeping the IPSS as the reference (Figure 3). The ROC gave us a cutoff of 4 points of LUTS-V for mild symptoms and 9 points for severe symptoms (Table 3). Keeping a cutoff of less than 4 for mild symptoms yielded a sensitivity of 73.68% and a specificity of 99.23%. This also had a high accuracy of 97.5 % (p = 0.001). The ROC revealed a cutoff of > 9 points for severe symptoms. Keeping a score of > 9 for severe symptoms, we achieved a high sensitivity of 95.35%, specificity of 83.07%, and accuracy of 86.3% (p = 0.0001). Table 3: Sensitivity, specificity, and accuracy of calculated cutoff values. =9 = SEVERE SENSITIVITY 73.68% 95.35% SPECIFICITY 99.23% 82.07% ACCURACY 97.50% 86.30% To confirm the findings objectively, we plotted the correlation of the score against the recorded maximum flow rate (MFR) through uroflowmetry. As expected, we found the score negatively correlated with the MFR (r = −0.2871, p = 0.0001). Using Students t-test, we found the MFR significantly associated with the LUTS-V (t = −13.06178, p = < .00001). One of the main purposes of the study was to project the advantage of the score’s simplicity. The time to solve the IPSS was an average 194.45 seconds (SD = 37.19767484) compared to 60.89 seconds (SD = 23.18) for the LUTS-V. This finding was statistically significant (t = 50.8022, p < .00001). Discussion Our study addresses the important issue of assessing LUTS in a population with a significant proportion of economically disadvantaged individuals. This is noteworthy because LUTS can be a debilitating condition, and illiterate or poorly educated patients face substantial challenges in understanding and completing traditional assessment tools such as the IPSS. The introduction of the LUTS-V, a simplified assessment tool based on the VPSS, is a notable contribution. Silva et al. [ 8 ] designed LUTS-V to overcome the language and education barriers often encountered with the IPSS. It uses pictograms to represent symptoms and their impact on quality of life, making it more accessible for patients with low education levels. This innovation is valuable because it streamlines the evaluation process and reduces the time required for scoring. Our study provides a detailed comparison between the LUTS-V and IPSS. The first introduced male LUTS evaluation form [ 10 ], the IPSS categorizes patients as asymptomatic (0 points), mild (1–7 points), moderate (8–19 points), and severe (20–35 points). However, it does not address hesitancy, incontinence, and post-void symptoms [ 11 ]. The correlation between these two instruments indicates that LUTS-V is a promising alternative for assessing LUTS, especially in populations with low literacy. The ROC analysis suggests that LUTS-V has strong diagnostic accuracy for identifying mild and severe symptoms, offering health care providers a useful tool for patient evaluation. A urodynamic pressure flow study is the gold standard in the diagnosis of BPH-related LUTS [ 9 ]. However, urodynamic studies are invasive and time-consuming, with a certain associated morbidity. Therefore, patient-reported symptom scores play an important part in evaluating patients with LUTS. In most of India’s regional centers, doctors have routinely adopted patient-reported symptom scores as part of history taking. Yao et al. [ 12 ] reported that the IPSS is available in 53 different languages, with statistically correct translation for clinical use in only 27. This covers a population of approximately 2.3 billion, which translates to 60% of the worldwide male population. We sought to solve this problem by trying to utilize a simplified picture-based scoring system [ 12 ]. Ölçücü et al. conducted a randomized control trial to compare the VPSS and IPSS and reported that patients’ educational level was an independent factor with the requirement of assistance to complete the VPSS. However, a university educational level was required to complete the IPSS. Additionally, the VPSS took statistically less time to complete compared to the IPSS. The LUTS-V is a modified version of the VPSS; therefore, similar benefits are applicable in our study.[ 13 ] Silva et al. [ 8 ] showed a positive correlation between the IPSS and LUTS-V total scores. They also found that LUTS-V had good accuracy in detecting more severe cases with a cutoff value of ≥ 4, providing a sensitivity of 74% and a specificity of 78% [ 8 ]. In our study we grouped the LUTS-V into mild, moderate, and severe symptoms. A cutoff of ≤ 4 points for mild symptoms and ≥ 9 for severe symptoms gave excellent sensitivity, specificity, and diagnostic accuracy. With respect to time to complete the scores, Laranjo-Tinoco et.al showed that the median time spent filling the IPSS was significantly longer than that of the VPSS (median = 175 seconds, versus median = 93.5 seconds). [ 14 ] The median completion time was 0.51 [0.41–1.07] minutes for LUTS-V and 2.5 [2.2–3.4] minutes for IPSS according to Silva et al. [ 8 ]. Our study had a similar trend, with IPSS taking more than three minutes (194.45 seconds) compared to just over one minute (60.89 seconds) for LUTS-V. A study by I.B.O.W. Putra et.al comparing IPSS and VPSS, reported that the ability to complete the IPSS questionnaire and educational attainment were significantly correlated. Similar observations were noted in our study and the LUTS-V score was more comprehensible to the insufficiently educated.[ 15 ] Our study’s results indicate that LUTS-V may be a practical and effective tool for evaluating LUTS, particularly for patients who may struggle with traditional questionnaires. The significant reduction in the time required to complete the LUTS-V compared to the IPSS suggests that it could be a more efficient option for busy clinical settings. Our study has a few limitations. First, we conducted it for a relatively shorter duration, which restricted the sample size. Second, patients could ask for assistance when completing the questionnaires. The introduction of this variable might introduce bias because the level and type of assistance provided could vary, affecting the accuracy and consistency of the responses. Third, we used a cross-sectional design and did not investigate LUTS-V’s long-term utility in monitoring patients or the stability of their symptoms over time. Longitudinal studies could provide insights into the tool’s suitability for tracking changes in LUTS and quality of life. Scholars should consider these limitations in future research in this area when interpreting and generalizing our study’s findings. Conclusion The LUTS-V is a simple, time-saving tool to assess patients with LUTS, especially in centers with high patient load, where the majority of the patients are poorly educated. The LUTS-V appears to have similar diagnostic efficacy as the IPSS. A score of less than 4 can be used to predict mild LUTS, 4–8 to predict moderate LUTS, and more than 9 to predict severe LUTS. Declarations ETHICAL APPROVAL AND CONSENT TO PARTICIPATE – Approved ( INU/RRC/04/2023-24 ) Internal review board – INU/RRC , Institute of Nephrourology, Bangalore Consent for publications – Obtained from the institution, research review board and all authors Availability of Data and material – Raw data and material shall be provided if required Competing interest – none Funding – no funds were obtained for the conduct of the study and publication Authors contributions Author 1 – conception and design Data acquisition Data analysis and interpretation Drafting and manuscript Statistical analysis Author 2 – Conception and design Data analysis and interpretation Drafting manuscript Critical revision of manuscript for scientific content Supervision Author 3 – Conception and design Data analysis and interpretation Critical revision of manuscript for scientific content Statistical analysis Supervision Correction of manuscript and proof reading References Soler R, Averbeck MA, Koyama MAH, Gomes CM: Impact of LUTS on treatment-related behaviors and quality of life: a population-based study in Brazil. Neurourol Urodyn. 2019, 38:1579-87.10.1002/nau.24004 Gravas, S., Cornu, J. N., Gacci, M., et. al. Management of non-neurogenic male lower urinary tract symptoms (LUTS), incl. benign prostatic obstruction (BPO) . (European Association of Urology. Guidelines ). European Association of Urology. https://uroweb.org/guideline/treatment-of-non-neurogenic-male-luts McKenna SP: Measuring patient-reported outcomes: moving beyond misplaced common sense to hard science. BMC Med. 2011, 9:8686.10.1186/1741-7015-9-86 Barry MJ, Fowler FJ Jr, O’Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT: The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992, 148:1549-57.10.1016/s0022-5347(17)36966-5 Johnson TV, Schoenberg ED, Abbasi A, et al.: Assessment of the performance of the American Urological Association symptom score in 2 distinct patient populations. J Urol. 2009, 181:230-7.10.1016/j.juro.2008.09.010 Sanman KN, Shetty R, Adapala RR, Patil S, Prabhu GL, Venugopal P: Can new, improvised Visual Prostate Symptom Score replace the International Prostate Symptom Score? Indian perspective. Indian J Urol. 2020, 36:123-129.10.4103/iju.IJU_300_19 Stothers L, Macnab A, Bajunirwe F, Mutabazi S, Lobatt C: Comprehension and construct validity of the Visual Prostate Symptom Score (VPSS) by men with obstructive lower urinary tract symptoms in rural Africa. Can Urol Assoc J. 2017, 11:E405-E408.10.5489/cuaj.4589 Silva CS, de Araujo UM, Alvaia MA, Freitas KS, Tiraboschi TLN, Gomes CM, de Bessa J Júnior: Luts-V: a new simplified score for assessing lower urinary tract symptoms in men. Int Braz J Urol. 2021, 47:525-532.10.1590/S1677-5538.IBJU.2020.0278 Abrams P, Chapple C, Khoury S, Roehrborn C, de la Rosette J: Evaluation and treatment of lower urinary tract symptoms in older men. J Urol. 2013, 189:S93-S101.10.1016/j.juro.2012.11.021 Barry MJ, Fowler FJ Jr, O’leary MP, et al.: The American Urological Association Symptom Index for benign prostatic hyperplasia. J Urol. 2017, 197:S189-197.10.1016/j.juro.2016.10.071 Yap TL, Cromwell DA, Brown C, van der Meulen J, Emberton M: The relationship between objective frequency-volume chart data and the I-PSS in men with lower urinary tract symptoms. Eur Urol. 2007, 52:811-818.10.1016/j.eururo.2007.01.013 Yao MW, Green JSA: How international is the International Prostate Symptom Score? A literature review of validated translations of the IPSS, the most widely used self-administered patient questionnaire for male lower urinary tract symptoms. Low Urin Tract Symptoms. 2022, 14:92-101. 10.1111/luts.12415 Ölçücü MT, Aydın ME, Avcı S, et. al.: Comparison of a Visual Prostate Symptom Score and International Prostate Symptom Score: A Prospective Multicenter Study and Literature Review. Urology. 2020 Dec;146:230-235. doi: 10.1016/j.urology.2020.09.001 Laranjo-Tinoco C, Ferreira F, Anacleto S, et. al.: A prospective comparison of Visual Prostate Symptom Score versus International Prostate Symptom Score in Portuguese men. Urological Science. 2024;35(1):e000003. doi: 10.1097/us9.0000000000000003 Putra IBOW, Hamid ARAH, Rasyid N, et. al.: Comparison of Visual Prostate Symptom Score with the International Prostate Symptom Score and uroflowmetry parameters in assessing men with lower urinary tract symptoms in Dr. Cipto Mangunkusumo National General Hospital, Indonesia. Prostate Int. 2019 Sep;7(3):91-95. doi: 10.1016/j.prnil.2018.09.001. 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. 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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-4705854","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":334833472,"identity":"8316eeea-82b4-492e-b8c7-88b638eba796","order_by":0,"name":"Ashwath Venkataramana VH","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA+ElEQVRIiWNgGAWjYFACHhBxAMqpAGJm5gYitCSAtDAD8RkQzUiKFsY2kAgBLfz9Z49J/PxxR86c/fzBx5XzaqP524FaflRsw6lF4kZemmRPwjNjy55kZsOz247nzjjM2MDYc+Y2bmtu8Jjd4Ek4nLjhQDKbZOO2Y7kNQC3MjG24tcifP2N280/C4foN5x8Dtcw5ljufkBaDAzlmt4G2JBjcANnSUJO7gZAWwxs55r9l0g4bbrjx2Niw4diB3I1ALQfx+UXu/Bljwzc2h+UNzic+fNhQU5c77/zhgw9+VODxPho4DCYPEK0eCOpIUTwKRsEoGAUjBAAAKRtifFSflWgAAAAASUVORK5CYII=","orcid":"","institution":"Institute of Nephro Urology","correspondingAuthor":true,"prefix":"","firstName":"Ashwath","middleName":"Venkataramana","lastName":"VH","suffix":""},{"id":334833473,"identity":"2d3519c2-b73e-4b21-8626-54515b0034d6","order_by":1,"name":"Shivakumar V","email":"","orcid":"","institution":"Institute of Nephro Urology","correspondingAuthor":false,"prefix":"","firstName":"Shivakumar","middleName":"","lastName":"V","suffix":""},{"id":334833474,"identity":"9c0ca9f9-b78a-4311-a10d-3ce45cff934c","order_by":2,"name":"Ramaiah Keshavamurthy","email":"","orcid":"","institution":"Institute of Nephro Urology","correspondingAuthor":false,"prefix":"","firstName":"Ramaiah","middleName":"","lastName":"Keshavamurthy","suffix":""}],"badges":[],"createdAt":"2024-07-08 13:21:03","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-4705854/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-4705854/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":62187942,"identity":"cc2cee5e-7128-4deb-91b6-4b8b78f14a43","added_by":"auto","created_at":"2024-08-10 12:13:16","extension":"jpg","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":63019,"visible":true,"origin":"","legend":"\u003cp\u003eLower Urinary Tract Symptoms Visual Score\u003cstrong\u003e (\u003c/strong\u003eLUTS-V score); Silva et al. [8].\u003c/p\u003e","description":"","filename":"fig1lutsv.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4705854/v1/ec3d0b9f40c119da8cac90ca.jpg"},{"id":62187940,"identity":"cc5c4932-63cb-41cd-919a-d429b4aad4a4","added_by":"auto","created_at":"2024-08-10 12:13:16","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":24745,"visible":true,"origin":"","legend":"\u003cp\u003eBar chart depicting the age distribution of the patient population.\u003c/p\u003e","description":"","filename":"fig2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4705854/v1/3a60cbd6761c85a83f582c2a.jpg"},{"id":62189315,"identity":"bcb2ebd3-1b87-4a72-8f66-a80abc74f362","added_by":"auto","created_at":"2024-08-10 12:21:16","extension":"jpg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":37504,"visible":true,"origin":"","legend":"\u003cp\u003eReceiver operative curve (ROC ) to detect cut off value for mild and severe Lower urinary tract symptoms.\u003c/p\u003e","description":"","filename":"fig3.jpg","url":"https://assets-eu.researchsquare.com/files/rs-4705854/v1/4fe4561c936ce493ff5be8a0.jpg"},{"id":84559984,"identity":"e4bc29b6-3294-4302-86ed-e18910abfb95","added_by":"auto","created_at":"2025-06-13 12:46:53","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":598010,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-4705854/v1/18fc7fb7-3366-49c1-9bff-7f18ebb29854.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Prospective Study to Compare the Efficacy of Lower Urinary Tract Symptoms Visual Score versus International Prostate Symptom Score for Evaluating Men With Lower Urinary Tract Symptoms","fulltext":[{"header":"Introduction","content":"\u003cp\u003eLUTS comprises a variety of urinary symptoms that can be detrimental to affected individuals\u0026rsquo; quality of life. It is frequently associated with other clinical conditions such as diabetes, neurological disorders, and erectile dysfunction [\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eVarious guidelines advise evaluating males with LUTS by initially using a validated symptom questionnaire [\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]. Patient-reported outcome assessments are useful tools for characterizing symptom burden and health-related quality of life, and they play an increasing role in clinical decision-making [\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eAt our institution\u0026mdash;a tertiary center mostly serving the economically disadvantaged segment of the population\u0026mdash;patients presenting with LUTS comprise a sizable fraction of daily OPD cases. Because of this, the vast majority of patients that come into our institution have lower levels of education. We assess men with LUTS using the IPSS, the most commonly used questionnaire [\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]. Patients with a lower education typically experience difficulty in accurately completing the IPSS [\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eWe faced three problems while using the IPSS at our OPD. First, the majority of the patients were illiterate in the English language. Therefore, we had to translate the IPSS into regional languages using different scripts. Some of the information was lost in the translation, or we could not translate it to provide the exact statement as the IPSS intended. For example, we found it difficult to translate \u0026ldquo;presence of symptoms less than 1 in 5 times\u0026rdquo; and differentiate it from \u0026ldquo;presence of symptoms less than half the times.\u0026rdquo;\u003c/p\u003e \u003cp\u003eSecond, those who were illiterate could not use the IPSS. We tried translating it and making the patients understand it in the form of systematic interviews. However, we noted that this led to bias because most patients could not differentiate their symptoms among the various groups.\u003c/p\u003e \u003cp\u003eThird, arriving at a meaningful score was time-consuming, and many clinicians avoided calculating patient-based scores.\u003c/p\u003e \u003cp\u003eThus, we needed a new simplified score to evaluate the presence of LUTS, so we used Van der Walt et al.\u0026rsquo;s VPSS. We used pictograms in this score for three symptoms, that is, frequency, nocturia, and weak stream, along with their impact on quality of life. The VPSS significantly correlated with the IPSS, and patients could complete it with no assistance. The original VPSS contained a pictorially depicted \u0026ldquo;stream of urine\u0026rdquo; with values ranging from 1 to 5. Using the VPSS, we overcame the barriers pertaining to language and level of education. This scoring system was relatively easy to interpret and complete especially because of the lack of mathematical calculations involved in the score [\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eHowever, the VPSS had a few limitations. A recurring theme in our research was the lack of clarity among many subjects regarding the symptom description used to assess nocturia and quality of life. Many patients objected to the VPSS\u0026rsquo;s black pictogram background [\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]. We suggested some improvements, such as clearer images for the pictograms that depicted urinary frequency and nocturia and images that depicted urinary urgency. Additionally, we noted that the VPSS gave a daytime micturition of five times a score of 5, which may falsely increase the overall score, whereas the IPSS gave a score of 5 for urgency ( urinating once every two hours).\u003c/p\u003e \u003cp\u003eSilva et al. addressed some of the drawbacks in their study on LUTS-V by developing a new simplified score for assessing LUTS in men [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. They revised the VPSS scoring system by resizing the images, altering the pictogram\u0026rsquo;s sequence and pattern, adding the possibility of nocturia absence, and grouping daytime frequencies. Additionally, they made conceptual changes and reduced the number of answers for the questions about daytime and nocturnal frequency from seven to four and the number of answers for the questions concerning quality of life from seven to three (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e Our institution agreed that we use this new simplified VPSS and test its efficacy against the IPSS in evaluating the symptoms of patients who presented with LUTS.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e"},{"header":"Methodology","content":"\u003cp\u003eWe obtained approval for our study from our institutional review board (No. INU/RRC/04/2023-24). We conducted a prospective non-interventional study over a period of eight months at the Institute of Nephro Urology in Bangalore, India. We included adult men of all ages who presented with LUTS and were mentally capable of understanding the instructions and providing a valid consent to participate in the study. We excluded patients who had undergone surgical or medical treatment for benign prostatic hyperplasia (BPH) or urethral stricture, had systemic neurological disease, had received chemotherapy owing to malignancy, had a history of pelvic radiotherapy, and who had received a diagnosis of neurogenic bladder.\u003c/p\u003e \u003cp\u003eWe needed 280 or more measurements or surveys to obtain a confidence interval of 95% so that the real value fell within \u0026plusmn;\u0026thinsp;5% of the measured or surveyed value. We maintained a margin of error of 5% in the above calculation.\u003c/p\u003e \u003cp\u003eWe gave patients both the scores at their initial presentation in the OPD and asked them to complete both the LUTS-V (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e) and the IPSS surveys at baseline. We conducted uroflowmetry at the initial presentation. The patients completed the self-administered questionnaires in a private, quiet room. They could ask for a designated researcher\u0026rsquo;s assistance in case of difficulty understanding or completing the surveys. Illiterate men completed the questionnaires in the form of a structured interview. We gave additional directions for the IPSS when required.\u003c/p\u003e \u003cp\u003eWe expressed data as medians and interquartile ranges, or as absolute values and fractions. We used the Mann\u0026ndash;Whitney U test to compare continuous variables and the chi-square and Fisher\u0026rsquo;s exact tests to compare categorical variables. We used the total IPSS and LUTS-V for each subject to determine the agreement between the two instruments using Bland\u0026ndash;Altman analysis and Spearman\u0026rsquo;s correlation plot. We used a plotted ROC curve to evaluate the diagnostic accuracy and the best cutoff point for LUTS-V. We described diagnostic properties (criteria validity) in terms of sensitivity, specificity, and accuracy.\u003c/p\u003e \u003cp\u003eWe used uroflowmetry as a reference standard for the construct validity analysis of LUTS-V. We measured the time (in minutes) necessary to complete each questionnaire. We considered all tests a p\u0026thinsp;\u0026lt;\u0026thinsp;0.05 as statistically significant.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eWe enrolled 280 patients in our study after obtaining their informed consent. Their mean age was 64.61 years (SD = 11.38). The majority of the patients (47.14%) were in the age group 60\u0026ndash;70 years. Patients older than 70 years comprised 33% of the study subjects, followed by the 50\u0026ndash;60 years group (10%). Patients younger than 50 years comprised only about 6% of the study population (Figure 2). \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn analyzing the education status (Table 1), we found that 50 of the 280 patients (17%) were illiterate; 127 patients (45%) had attended primary school, considered as one to four years of\u0026nbsp;education; and 63 patients (22.5%) had attended school up to middle school, that is, five to eight years of education. Only 40 patients (14%) had attained an education of high school level (more than eight years of school). We also found a statistically significant age-dependent reduction in the education status. Mean years of schooling for patients younger than 60 years was 9.7 years, whereas mean years of schooling for patients older than 60 years was only 4.54 school years (p \u0026lt; 0.0001).\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;Table 1: Education status of patient population.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" align=\"\" width=\"548\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"53.93053016453382%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eLITERACY STATUS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.937842778793417%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eFREQUENCY\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.13162705667276%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ePERCENTAGE\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"53.93053016453382%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eILLITERATE\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.937842778793417%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e50\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.13162705667276%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e17%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"53.93053016453382%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ePRIMARY SCHOOL\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.937842778793417%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e127\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.13162705667276%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e45%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"53.93053016453382%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eMID SCHOOL\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.937842778793417%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e63\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.13162705667276%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e22.50%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"53.93053016453382%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eHIGH SCHOOL\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.937842778793417%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e40\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.13162705667276%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e14.28%\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"53.93053016453382%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eMEAN YEARS OF EDUCATION FOR PATIENTS AGED \u0026lt; 60 YEARS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.937842778793417%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e9.7\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.13162705667276%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"53.93053016453382%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eMEAN YEARS OF EDUCATION FOR PATIENTS AGED \u0026gt; 60 YEARS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"21.937842778793417%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e4.54\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"24.13162705667276%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eThe mean IPSS of the patient population was 16.82 (Table 2). Most of them (185 = 66%) presented to us only when the symptoms became severe, whereas 86 patients (30.71%) had moderate symptoms. Only nine patients (3.2%) had mild symptoms. All but 18 patients requested assistance while filling in the IPSS form.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;Table 2: International Prostate Symptom Score\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003edistribution of patient population.\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" align=\"\" width=\"463\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.63714902807775%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eIPPS GRADE\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"29.58963282937365%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eFREQUENCY\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"34.77321814254859%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003ePERCENTAGE\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.63714902807775%\" valign=\"top\"\u003e\n \u003cp\u003eMILD (0-7)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"29.58963282937365%\" valign=\"top\"\u003e\n \u003cp\u003e9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"34.77321814254859%\" valign=\"top\"\u003e\n \u003cp\u003e3.20%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.63714902807775%\" valign=\"top\"\u003e\n \u003cp\u003eMODERATE(8-19)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"29.58963282937365%\" valign=\"top\"\u003e\n \u003cp\u003e86\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"34.77321814254859%\" valign=\"top\"\u003e\n \u003cp\u003e30.71%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.63714902807775%\" valign=\"top\"\u003e\n \u003cp\u003eSEVERE(20-35)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"29.58963282937365%\" valign=\"top\"\u003e\n \u003cp\u003e185\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"34.77321814254859%\" valign=\"top\"\u003e\n \u003cp\u003e66.01%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"35.63714902807775%\" valign=\"top\"\u003e\n \u003cp\u003eMEAN\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"29.58963282937365%\" valign=\"top\"\u003e\n \u003cp\u003e16.8209\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"34.77321814254859%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eWe then compared the LUTS-V to the IPSS. We found the LUTS-V had a statistically significant positive correlation with the IPSS on applying Pearson\u0026rsquo;s correlation coefficient (r = 0.54, p \u0026lt; 0.001).\u003c/p\u003e\n\u003cp\u003eWe plotted ROC curves of the LUTS-V regarding the severity of the symptoms, keeping the IPSS as the reference (Figure 3). The ROC gave us a cutoff of 4 points of LUTS-V for mild symptoms and 9 points for severe symptoms (Table 3). Keeping a cutoff of less than 4 for mild symptoms yielded a sensitivity of 73.68% and a specificity of 99.23%. This also had a high accuracy of 97.5 % (p = 0.001).\u003c/p\u003e\n\u003cp\u003eThe ROC revealed a cutoff of \u0026gt; 9 points for severe symptoms. Keeping a score of \u0026gt; 9 for severe symptoms, we achieved a high sensitivity of 95.35%, specificity of 83.07%, and accuracy of 86.3% (p = 0.0001).\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;Table 3: Sensitivity, specificity, and accuracy of calculated cutoff values.\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" align=\"\" width=\"373\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd width=\"31.182795698924732%\" valign=\"top\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"31.182795698924732%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026lt;=4=MILD\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.634408602150536%\" valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026gt;=9 = SEVERE\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"31.182795698924732%\" valign=\"top\"\u003e\n \u003cp\u003eSENSITIVITY\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"31.182795698924732%\" valign=\"top\"\u003e\n \u003cp\u003e73.68%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.634408602150536%\" valign=\"top\"\u003e\n \u003cp\u003e95.35%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"31.182795698924732%\" valign=\"top\"\u003e\n \u003cp\u003eSPECIFICITY\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"31.182795698924732%\" valign=\"top\"\u003e\n \u003cp\u003e99.23%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.634408602150536%\" valign=\"top\"\u003e\n \u003cp\u003e82.07%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd width=\"31.182795698924732%\" valign=\"top\"\u003e\n \u003cp\u003eACCURACY\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"31.182795698924732%\" valign=\"top\"\u003e\n \u003cp\u003e97.50%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd width=\"37.634408602150536%\" valign=\"top\"\u003e\n \u003cp\u003e86.30%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eTo confirm the findings objectively, we plotted the correlation of the score against the recorded maximum flow rate (MFR) through uroflowmetry. As expected, we found the score negatively correlated with the MFR (r = \u0026minus;0.2871, p = 0.0001). Using Students t-test, we found the MFR significantly associated with the LUTS-V (t = \u0026minus;13.06178, p = \u0026lt; .00001).\u003c/p\u003e\n\u003cp\u003eOne of the main purposes of the study was to project the advantage of the score\u0026rsquo;s simplicity. The time to solve the IPSS was an average 194.45 seconds (SD = 37.19767484) compared to 60.89 seconds (SD = 23.18) for the LUTS-V. This finding was statistically significant (t = 50.8022, p \u0026lt; .00001).\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eOur study addresses the important issue of assessing LUTS in a population with a significant proportion of economically disadvantaged individuals. This is noteworthy because LUTS can be a debilitating condition, and illiterate or poorly educated patients face substantial challenges in understanding and completing traditional assessment tools such as the IPSS.\u003c/p\u003e \u003cp\u003eThe introduction of the LUTS-V, a simplified assessment tool based on the VPSS, is a notable contribution. Silva et al. [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e] designed LUTS-V to overcome the language and education barriers often encountered with the IPSS. It uses pictograms to represent symptoms and their impact on quality of life, making it more accessible for patients with low education levels. This innovation is valuable because it streamlines the evaluation process and reduces the time required for scoring.\u003c/p\u003e \u003cp\u003eOur study provides a detailed comparison between the LUTS-V and IPSS. The first introduced male LUTS evaluation form [\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e], the IPSS categorizes patients as asymptomatic (0 points), mild (1\u0026ndash;7 points), moderate (8\u0026ndash;19 points), and severe (20\u0026ndash;35 points). However, it does not address hesitancy, incontinence, and post-void symptoms [\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e].\u003c/p\u003e \u003cp\u003eThe correlation between these two instruments indicates that LUTS-V is a promising alternative for assessing LUTS, especially in populations with low literacy. The ROC analysis suggests that LUTS-V has strong diagnostic accuracy for identifying mild and severe symptoms, offering health care providers a useful tool for patient evaluation.\u003c/p\u003e \u003cp\u003eA urodynamic pressure flow study is the gold standard in the diagnosis of BPH-related LUTS [\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]. However, urodynamic studies are invasive and time-consuming, with a certain associated morbidity. Therefore, patient-reported symptom scores play an important part in evaluating patients with LUTS. In most of India\u0026rsquo;s regional centers, doctors have routinely adopted patient-reported symptom scores as part of history taking.\u003c/p\u003e \u003cp\u003eYao et al. [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e] reported that the IPSS is available in 53 different languages, with statistically correct translation for clinical use in only 27. This covers a population of approximately 2.3\u0026nbsp;billion, which translates to 60% of the worldwide male population. We sought to solve this problem by trying to utilize a simplified picture-based scoring system [\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e].\u003c/p\u003e \u003cp\u003e\u0026Ouml;l\u0026ccedil;\u0026uuml;c\u0026uuml; et al. conducted a randomized control trial to compare the VPSS and IPSS and reported that patients\u0026rsquo; educational level was an independent factor with the requirement of assistance to complete the VPSS. However, a university educational level was required to complete the IPSS. Additionally, the VPSS took statistically less time to complete compared to the IPSS. The LUTS-V is a modified version of the VPSS; therefore, similar benefits are applicable in our study.[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eSilva et al. [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e] showed a positive correlation between the IPSS and LUTS-V total scores. They also found that LUTS-V had good accuracy in detecting more severe cases with a cutoff value of \u0026ge;\u0026thinsp;4, providing a sensitivity of 74% and a specificity of 78% [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. In our study we grouped the LUTS-V into mild, moderate, and severe symptoms. A cutoff of \u0026le;\u0026thinsp;4 points for mild symptoms and \u0026ge;\u0026thinsp;9 for severe symptoms gave excellent sensitivity, specificity, and diagnostic accuracy.\u003c/p\u003e \u003cp\u003eWith respect to time to complete the scores, Laranjo-Tinoco et.al showed that the median time spent filling the IPSS was significantly longer than that of the VPSS (median\u0026thinsp;=\u0026thinsp;175 seconds, versus median\u0026thinsp;=\u0026thinsp;93.5 seconds). [\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e] The median completion time was 0.51 [0.41\u0026ndash;1.07] minutes for LUTS-V and 2.5 [2.2\u0026ndash;3.4] minutes for IPSS according to Silva et al. [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]. Our study had a similar trend, with IPSS taking more than three minutes (194.45 seconds) compared to just over one minute (60.89 seconds) for LUTS-V.\u003c/p\u003e \u003cp\u003eA study by I.B.O.W. Putra et.al comparing IPSS and VPSS, reported that the ability to complete the IPSS questionnaire and educational attainment were significantly correlated. Similar observations were noted in our study and the LUTS-V score was more comprehensible to the insufficiently educated.[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]\u003c/p\u003e \u003cp\u003eOur study\u0026rsquo;s results indicate that LUTS-V may be a practical and effective tool for evaluating LUTS, particularly for patients who may struggle with traditional questionnaires. The significant reduction in the time required to complete the LUTS-V compared to the IPSS suggests that it could be a more efficient option for busy clinical settings.\u003c/p\u003e \u003cp\u003eOur study has a few limitations. First, we conducted it for a relatively shorter duration, which restricted the sample size. Second, patients could ask for assistance when completing the questionnaires. The introduction of this variable might introduce bias because the level and type of assistance provided could vary, affecting the accuracy and consistency of the responses. Third, we used a cross-sectional design and did not investigate LUTS-V\u0026rsquo;s long-term utility in monitoring patients or the stability of their symptoms over time. Longitudinal studies could provide insights into the tool\u0026rsquo;s suitability for tracking changes in LUTS and quality of life. Scholars should consider these limitations in future research in this area when interpreting and generalizing our study\u0026rsquo;s findings.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe LUTS-V is a simple, time-saving tool to assess patients with LUTS, especially in centers with high patient load, where the majority of the patients are poorly educated. The LUTS-V appears to have similar diagnostic efficacy as the IPSS. A score of less than 4 can be used to predict mild LUTS, 4\u0026ndash;8 to predict moderate LUTS, and more than 9 to predict severe LUTS.\u003c/p\u003e"},{"header":"Declarations","content":"\u003col\u003e\n \u003cli\u003eETHICAL APPROVAL AND CONSENT TO PARTICIPATE \u0026ndash; Approved \u0026nbsp; (\u003cstrong\u003eINU/RRC/04/2023-24\u003c/strong\u003e\u003cstrong\u003e)\u003c/strong\u003e\u003c/li\u003e\n \u003cli\u003eInternal review board \u0026ndash; INU/RRC , Institute of Nephrourology, Bangalore\u003c/li\u003e\n \u003cli\u003eConsent for publications \u0026ndash; Obtained \u0026nbsp;from the institution, research review board \u0026nbsp;and all authors\u003c/li\u003e\n \u003cli\u003eAvailability of Data and material \u0026ndash; Raw data and material shall be provided if required\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eCompeting interest \u0026ndash; none\u003c/li\u003e\n \u003cli\u003eFunding \u0026ndash; no funds were obtained for the conduct of the study and publication\u003c/li\u003e\n \u003cli\u003eAuthors contributions\u0026nbsp;\u003col style=\"list-style-type: lower-alpha;\"\u003e\n \u003cli\u003eAuthor 1 \u0026ndash;\u0026nbsp;\u003col style=\"list-style-type: lower-roman;\"\u003e\n \u003cli\u003econception and design\u003c/li\u003e\n \u003cli\u003eData acquisition\u003c/li\u003e\n \u003cli\u003eData analysis and interpretation\u003c/li\u003e\n \u003cli\u003eDrafting and manuscript\u003c/li\u003e\n \u003cli\u003eStatistical analysis\u003c/li\u003e\n \u003c/ol\u003e\n \u003c/li\u003e\n \u003cli\u003eAuthor 2 \u0026ndash;\u003col style=\"list-style-type: lower-roman;\"\u003e\n \u003cli\u003eConception and design\u003c/li\u003e\n \u003cli\u003eData analysis and interpretation\u003c/li\u003e\n \u003cli\u003eDrafting manuscript\u003c/li\u003e\n \u003cli\u003eCritical revision of manuscript for scientific content\u003c/li\u003e\n \u003cli\u003eSupervision\u003c/li\u003e\n \u003c/ol\u003e\n \u003c/li\u003e\n \u003cli\u003eAuthor 3 \u0026ndash;\u003col style=\"list-style-type: lower-roman;\"\u003e\n \u003cli\u003eConception and design\u003c/li\u003e\n \u003cli\u003eData analysis and interpretation\u003c/li\u003e\n \u003cli\u003eCritical revision of manuscript for scientific content\u003c/li\u003e\n \u003cli\u003eStatistical analysis\u003c/li\u003e\n \u003cli\u003eSupervision\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eCorrection of manuscript and proof reading\u0026nbsp;\u003c/li\u003e\n \u003c/ol\u003e\n \u003c/li\u003e\n \u003c/ol\u003e\n \u003c/li\u003e\n\u003c/ol\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eSoler R, Averbeck MA, Koyama MAH, Gomes CM: Impact of LUTS on treatment-related behaviors and quality of life: a population-based study in Brazil. Neurourol Urodyn. 2019, 38:1579-87.10.1002/nau.24004\u003c/li\u003e\n\u003cli\u003eGravas, S., Cornu, J. N., Gacci, M., et. al. \u003cem\u003eManagement of non-neurogenic male lower urinary tract symptoms (LUTS), incl. benign prostatic obstruction (BPO)\u003c/em\u003e. (European Association of Urology. Guidelines ). European Association of Urology. https://uroweb.org/guideline/treatment-of-non-neurogenic-male-luts\u003c/li\u003e\n\u003cli\u003eMcKenna SP: Measuring patient-reported outcomes: moving beyond misplaced common sense to hard science. BMC Med. 2011, 9:8686.10.1186/1741-7015-9-86\u003c/li\u003e\n\u003cli\u003eBarry MJ, Fowler FJ Jr, O\u0026rsquo;Leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT: The American Urological Association symptom index for benign prostatic hyperplasia. The Measurement Committee of the American Urological Association. J Urol. 1992, 148:1549-57.10.1016/s0022-5347(17)36966-5\u003c/li\u003e\n\u003cli\u003eJohnson TV, Schoenberg ED, Abbasi A, et al.: Assessment of the performance of the American Urological Association symptom score in 2 distinct patient populations. J Urol. 2009, 181:230-7.10.1016/j.juro.2008.09.010\u003c/li\u003e\n\u003cli\u003eSanman KN, Shetty R, Adapala RR, Patil S, Prabhu GL, Venugopal P: Can new, improvised Visual Prostate Symptom Score replace the International Prostate Symptom Score? Indian perspective. Indian J Urol. 2020, 36:123-129.10.4103/iju.IJU_300_19\u003c/li\u003e\n\u003cli\u003eStothers L, Macnab A, Bajunirwe F, Mutabazi S, Lobatt C: Comprehension and construct validity of the Visual Prostate Symptom Score (VPSS) by men with obstructive lower urinary tract symptoms in rural Africa. Can Urol Assoc J. 2017, 11:E405-E408.10.5489/cuaj.4589\u003c/li\u003e\n\u003cli\u003eSilva CS, de Araujo UM, Alvaia MA, Freitas KS, Tiraboschi TLN, Gomes CM, de Bessa J J\u0026uacute;nior: Luts-V: a new simplified score for assessing lower urinary tract symptoms in men. Int Braz J Urol. 2021, 47:525-532.10.1590/S1677-5538.IBJU.2020.0278\u003c/li\u003e\n\u003cli\u003eAbrams P, Chapple C, Khoury S, Roehrborn C, de la Rosette J: Evaluation and treatment of lower urinary tract symptoms in older men. J Urol. 2013, 189:S93-S101.10.1016/j.juro.2012.11.021\u003c/li\u003e\n\u003cli\u003eBarry MJ, Fowler FJ Jr, O\u0026rsquo;leary MP, et al.: The American Urological Association Symptom Index for benign prostatic hyperplasia. J Urol. 2017, 197:S189-197.10.1016/j.juro.2016.10.071\u003c/li\u003e\n\u003cli\u003eYap TL, Cromwell DA, Brown C, van der Meulen J, Emberton M: The relationship between objective frequency-volume chart data and the I-PSS in men with lower urinary tract symptoms. Eur Urol. 2007, 52:811-818.10.1016/j.eururo.2007.01.013\u003c/li\u003e\n\u003cli\u003eYao MW, Green JSA: How international is the International Prostate Symptom Score? A literature review of validated translations of the IPSS, the most widely used self-administered patient questionnaire for male lower urinary tract symptoms. Low Urin Tract Symptoms. 2022, 14:92-101. 10.1111/luts.12415\u003c/li\u003e\n\u003cli\u003e\u0026Ouml;l\u0026ccedil;\u0026uuml;c\u0026uuml; MT, Aydın ME, Avcı S, et. al.: Comparison of a Visual Prostate Symptom Score and International Prostate Symptom Score: A Prospective Multicenter Study and Literature Review. Urology. 2020 Dec;146:230-235. doi: 10.1016/j.urology.2020.09.001\u003c/li\u003e\n\u003cli\u003eLaranjo-Tinoco C, Ferreira F, Anacleto S, et. al.: A prospective comparison of Visual Prostate Symptom Score versus International Prostate Symptom Score in Portuguese men. \u003cem\u003eUrological Science.\u003c/em\u003e 2024;35(1):e000003. doi: 10.1097/us9.0000000000000003\u003c/li\u003e\n\u003cli\u003ePutra IBOW, Hamid ARAH, Rasyid N, et. al.: Comparison of Visual Prostate Symptom Score with the International Prostate Symptom Score and uroflowmetry parameters in assessing men with lower urinary tract symptoms in Dr. Cipto Mangunkusumo National General Hospital, Indonesia. Prostate Int. 2019 Sep;7(3):91-95. doi: 10.1016/j.prnil.2018.09.001.\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":"","lastPublishedDoi":"10.21203/rs.3.rs-4705854/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-4705854/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eAim and Objective\u003c/h2\u003e \u003cp\u003eThe number of men presenting with lower urinary tract symptoms (LUTS) to our institute\u0026rsquo;s outpatient department (OPD) is exceedingly high. Because most of the patients who visit the OPD are illiterate or undereducated, using advanced patient-based symptom measures such as the gold standard International Prostate Symptom Score (IPSS) is difficult. This calls for a less complicated grading scheme. Thus, our objective in this study is to evaluate the effectiveness of our institute\u0026rsquo;s lower urinary tract symptoms visual score (LUTS-V), a condensed score based on a visual scoring method that Silva et al. described.\u003c/p\u003e\u003ch2\u003eMaterial and Methods\u003c/h2\u003e \u003cp\u003eSilva et.al. [\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e] developed LUTS-V, a modified form of the visual prostate symptom score (VPSS). We prospectively instructed patients presenting with LUTS to the OPD to fill their LUTS-V and IPSS scores at their first OPD visit. We conducted our study over a period of eight months at the Institute of Nephro Urology, a tertiary center in Bangalore, Karnataka, India. We expressed data as medians and ranges, or absolute values and fractions. We tested the overall IPSS and LUTS-V scores for agreeability using Bland\u0026ndash;Altman analysis, Spearman\u0026rsquo;s correlation plot, and the Pearson correlation coefficient. We evaluated diagnostic properties (criteria validity) in terms of sensitivity, specificity, and accuracy. We used uroflowmetry as a reference standard. We measured the time (in seconds) necessary for completion of each IPSS and LUTS-V questionnaire. We considered p\u0026thinsp;\u0026lt;\u0026thinsp;0.05 as statistically significant.\u003c/p\u003e\u003ch2\u003eResult\u003c/h2\u003e \u003cp\u003eWe included 280 patients in the study, ranging in age from 22 to 80 years with a mean age of 64.61 years. The patient cohort had a mean education of 7.41 years. Education status was inversely related to age according to the Pearson correlation coefficient (r\u0026thinsp;=\u0026thinsp;\u0026minus;\u0026thinsp;0.7122, p\u0026thinsp;\u0026lt;\u0026thinsp;.00001). We found that 3.2% of patients had mild symptoms, 86% had moderate symptoms, and 66.01% had severe symptoms. LUTS-V ranged from 1 to 12. We divided the patients into mild, moderate, and severe symptomatic groups and compared them with similar groups with the IPSS. Receiver operating characteristic (ROC) analysis gave us a cutoff of 4 points of LUTS-V for mild symptom and 9 points for severe symptoms. A cutoff less than 4 for mild symptoms yielded sensitivity of 73.68%, specificity of 99.23%, and accuracy of 97.5% (p\u0026thinsp;=\u0026thinsp;0.001), whereas a cutoff more than 9 points for severe symptoms had high sensitivity of 95.35%, specificity of 83.07%, and accuracy of 86.3% (p\u0026thinsp;=\u0026thinsp;0.0001). The patients took an average of 195 seconds to complete the IPPS, and many required help in understanding the IPSS score, whereas they took an average of 60.89 sec to complete the LUTS-V (p\u0026thinsp;\u0026lt;\u0026thinsp;0.001).\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eLUTS-V is a simplified tool that has adequate comparability to the gold standard IPSS, which patients with a poor educational background can easily interpret.\u003c/p\u003e","manuscriptTitle":"Prospective Study to Compare the Efficacy of Lower Urinary Tract Symptoms Visual Score versus International Prostate Symptom Score for Evaluating Men With Lower Urinary Tract Symptoms","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-08-10 12:13:12","doi":"10.21203/rs.3.rs-4705854/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":"e9dbf6a5-49b1-4610-bb16-833f4f4cae99","owner":[],"postedDate":"August 10th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-06-13T12:38:43+00:00","versionOfRecord":[],"versionCreatedAt":"2024-08-10 12:13:12","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-4705854","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-4705854","identity":"rs-4705854","version":["v1"]},"buildId":"qtupq5eGEP_6zYnWcrvyt","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}