Stesura Seveso Archivio Italiano di Urologia e Andrologia 2024; 96(2):12415 1 ORIGINAL PAPER age, LUTS are common in both females and males with similar incidences. Rates of storage, voiding, and post- micturition symptoms in females and males are 51.3% vs 59.2%, 25.7% vs 19.5%, and 16.9% vs 14.2%, respec- tively (1). These patients admit to clinic suffering from usually more than one symptom. Therefore, symptom scores obtained from questionnaires are often used for evaluation of these patients (2). The International Prostate Symptom Score (IPSS) has been a well-known and frequently used symptom index for many years. Despite its prevalent utilization, there are some drawbacks of the IPSS. It was devised for males and does not interrogate symptoms such as incontinence and post-void dribbling. On the other hand, Overactive Bladder Questionnaire V8 (OAB-V8), which is also com- monly used, inquiries about frequency, urgency, urge or stress incontinence, and nocturia. It was conceived for both males and females, but it covers predominantly stor- age symptoms and does not question voiding difficulty. As a result, a questionnaire which evaluates both males and females and involves all the important lower urinary tract symptoms will be of benefit for clinicians. “Comprehensive Assessment of Self-Reported Urinary Symptoms (CASUS)” questionnaire, which consists of 93 questions covering a wider spectrum of symptoms when compared with other questionnaires, was developed to enhance phenotypical analyses of the patients with LUTS by The Lower Urinary Tract Dysfunction Research Network (LURN) (3). Based upon CASUS, which is impractical in clinical use because of its length, Cella and colleagues devised and reported first the LURN symptom index of 29 items (LURN SI-29) and thereafter LURN symptom index of 10 items (LURN SI-10) by abridging the former (4). In these studies, it is stated that a shorter and successful measure (LURN SI-10) in correlation with the clinical presentation is obtained, which is also more comprehen- sive than present LUTS questionnaires and applicable to both males and females (5). In this study, we aimed to investigate the validity and reli- ability of the LURN SI-10 questionnaire, which was trans- lated into Turkish before, in patients with LUTS. Introduction: To evaluate the validity and reliability of the Turkish version of the Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-10 (LURN SI-10). Materials and methods: In this, single-centre study, patients between 18 and 65 years old, who were suffering from lower urinary tract symptoms (LUTS) without any known urinary tract disease and on no medication, were enrolled. The control group consisted of participants, who were admitted to our clinic suffering from any complaint except LUTS and met all of the other inclusion and exclusion criteria. Participants’ demograph- ics such as age, sex, and level of education were recorded. The Turkish version of the LURN SI-10, International Prostate Symptom Score (IPSS) and Overactive Bladder Questionnaire (OAB-V8) were administered to all participants. Construct validity was evaluated by confirmatory factor analysis and con- current validity was evaluated with correlations to similar measures. Internal consistency (Cronbach's alpha) was used to establish the scale's internal consistency reliability. Results: A total of 164 participants were included in the final analysis. Of those, 57% were male. The individuals were identi- fied as being in the “patient group” (n = 86) and a “control group” (n = 78). The mean age was 48.24 ± 14.30 years. The median total LURN SI-10 scores of patient group and con- trol group were 12.0 (9-18.25) and 4.0 (2.75-6), respectively. The LURN SI-10 questionnaire showed a high correlation with the IPSS and the OAB-V8 questionnaires (r: 0.761; p: 0.001; r: 0.737; p: 0.001, respectively) in concurrent validity analysis. Cronbach’s alpha coefficient of the LURN SI-10 was 0.850. Conclusions: This promising measurement tool can be used to evaluate LUTS in Turkish women and men. Further studies should be conducted to assess the clinical usefulness of this questionnaire. KEY WORDS: LURN SI-10; LUTS; Patient reported outcomes; Questionnaires; Turkish. Submitted 22 February 2024; Accepted 28 March 2024 INTRODUCTION Lower urinary tract symptoms (LUTS), which include stor- age, voiding, and post-micturition symptoms, are related with lower urinary tract dysfunction. Above 40 years of Reliability and validity analysis of Turkish version of the Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-10 questionnaire Serkan Akan 1, Hasan Huseyin Tavukcu 2, Meftun Culpan 3, David Cella 4 1 Department of Urology, University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey; 2 Department of Urology, Medipol University Camlica Hospital, Istanbul, Turkey; 3 Department of Urology, Faculty of Medicine, Istanbul Medeniyet University, Istanbul, Turkey; 4 Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA. DOI: 10.4081/aiua.2024.12415 Summary Archivio Italiano di Urologia e Andrologia 2024; 96(2):12415 S. Akan, H. Huseyin Tavukcu, M. Culpan, D. Cella 2 MATERIALS AND METHODS We obtained a written approval of the developers of the LURN SI-10 index for validating it in Turkish language. The local ethics committee endorsed the study with deci- sion number 2022/70 in accordance with the Helsinki Declaration. A written informed consent was signed by all individuals. Patient population We planned to enrol a minimum of 70 patients, who admit to our clinic suffering from LUTS, and a minimum of 70 participants for control group between September 2022 and October 2023 prospectively. Our inclusion cri- teria were: [1] admission to our clinic with clinically sig- nificant LUTS, [2] age between 18 and 65 years, [3] answering all the questions in each questionnaire, [4] signing the written informed consent. Our exclusion crite- ria were: [1] using medications such as alpha blockers, antimuscarinic agents, beta-mimetics, pain killers or drugs potentially impairing lower urinary tract functions, [2] a history of overactive bladder, bladder cancer, chronic pelvic pain syndrome, chronic prostatitis, prostate cancer, and a neurological disorder potentially causing lower uri- nary tract dysfunction, [3] presence of temporary or per- manent urethral or ureteral catheter, [4] presence of a debilitative disorder, [5] being unable to communicate. The control group consisted of participants, who admitted to our clinic suffering from any complaint expect LUTS and met all the other inclusion and exclusion criteria. Tools for data collection Demographic data of the participants such as age, sex, education level were collected. All individuals took The Turkish version of the LURN SI-10 and validated Turkish versions of the IPSS and OAB-V8 questionnaires (6, 7). They were requested to complete the questionnaires on their own without professional aid at first application. LURN SI-10 The LURN SI-10, first published in 2020, was conceived as a self-reported outcome questionnaire for clinical use with patients to assess LUTS 2020 (5). It includes 10 questions about frequency, nocturia, urgency, inconti- nence, bladder pain, voiding, and post-micturition symp- toms as well as an additional question measuring dissat- isfaction with LUTS. Each question scores between zero and four according to frequency of the symptom (Nineth and tenth questions between zero and three). The total score is calculated as “the total score of ten questions x 10/number of the questions answered” (maximum score 38). Last question about dissatisfaction with LUTS is about quality of life and does not affect the total score. IPSS The IPSS consists of eight questions and is usually used for screening, diagnosing and treatment planning of benign prostate obstruction (BPO). Seven questions investi- gate incomplete emptying of the bladder, frequency, intermittency, urgency, weak stream, straining, and noc- turia. The eighth question is about overall quality of life. A score between zero and seven means mild, between eight and 19 means moderate, and between 20 and 35 means severe symptoms. Although IPSS is generally used in males with the diagnosis of BPO, it is not specific for males or prostate diseases (8). OAB-V8 The Overactive Bladder Questionnaire (OAB-Q) was devel- oped in 2002 by Coyne and colleagues as a questionnaire for OAB symptoms and quality of life (9). It can be used in patients with a provisional diagnosis of both wet and dry OAB. The OAB-V8 consists of the first eight questions of the OAB-q and is recommended as a screening and awareness test for OAB (10). A score between zero and seven indicates mild symptoms and eight and 40 indi- cates severe symptoms. Tarcan and colleagues validated OAB-V8 in Turkish language in 2012 (11). Linguistic validation We obtained a written approval of the developers of the LURN SI-10 index for validating it in Turkish language. The Turkish LURN SI-10 questionnaire, which was not validated in Turkish language but developed based upon Turkish LURN SI-29 questionnaire (12), which was vali- dated in Turkish and published in 2021, was sent to the corresponding author by developers of LURN SI-10 and used in this study. Statistical analysis For statistical analyses, IBM SPSS Statistics 22 and AMOS 22 computer programs were used. Normally distribution of the data was controlled by Kolmogorov-Smirnov test. Findings were represented with descriptive statistical methods (minimum, maximum, mean, standard devia- tion, median, frequency). In comparison of quantitative data, normally distributed groups were compared by using Student t test and non-normally distributed groups were compared by using Mann Whitney U test. Qualitative data were compared by using Chi-square test. Exploratory factor analysis (EFA) was performed to test the construct validity of the LURN SI-10. Kaiser-Meyer-Olkin (KMO) test was used to assess the sufficiency of the sam- ple for the factor analysis. Bartlett test demonstrated the correlation among variables. For evaluating the construct validity, confirmatory factor analysis (CFA) test was applied. Model fit was tested by using the χ2 goodness of fit test (χ2, χ2/degree of freedom [df]), the goodness of fit index (GFI), root mean square error of approximation (RMSEA), the comparative fit index (CFI), and the non- normed fit index (NNFI). Cronbach’s alpha coefficient was calculated for reliability of the scale. Association between non-normally distributed parame- ters was controlled by using Spearman’s rho correlation test. Partial correlation analysis was performed for evalu- ating the correlation between scores after adjustment for age. A p value less than 0.05 was considered statistically significant. RESULTS Due to incomplete questionnaires, nine participants were excluded. A total of 164 individuals between the age of 18 and 65 years were enrolled in the study. Of those, 71 (43.3%) were female, 93 (56.7%) were male, 86 were in Archivio Italiano di Urologia e Andrologia 2024; 96(2):12415 3 Turkish version of LURN SI-10 questionnaire the patient group, and 78 were in the control group. The ratio of the females in the patient group was significantly higher than that in the control group (55.8% vs 29.5%, p < 0.05). The mean age of all participants was 48.24 ± 14.30 years. In the patient and control groups, the mean ages were 50.95 ± 11.79 and 45.24 ± 16.20 years, respec- tively. The mean age of the patient group was higher than that of the control group significantly (p < 0.05). The median total LURN SI-10 scores were 12.0 (9-18.25) vs 4.0 (2.75-6) in patient group and control group, respectively (p < 0.001). The median total IPSS scores were 14.0 (9-21.25) vs 4.5 (2-7) in patient group and control group, respectively (p < 0.001). The median total OAB-V8 scores were 20.5 (12-28) vs 7.0 (4.75-9.25) in patient group and control group, respectively (p < 0.001). Table 1 and Figure 1 demonstrate the LURN SI- 10, IPSS and OAB-V8 scores and scale graphs of the groups, respectively. The validity of the scale Exploratory factor analysis (EFA) was performed to test the construct validity of the scale. Principal component analy- sis and varimax rotation were used in the factor analysis. Associations of LURN SI-10 total score with IPSS and OAB-V8 were assessed for concurrent validity. The LURN SI-10 total score demonstrated a high correlation with those of IPSS and OAB-V8 (r = 0.761, p < 0.001 and r = 0.737, p < 0.001, respectively). Figure 2 shows the cor- relations of LURN SI-10 with IPSS and OAB-V8. When all individuals were assessed, a high, positive, and statistically significant correlation between both LURN SI-10 vs IPSS (0.76) and LURN SI-10 vs OAB-V8 (0.73) were observed (p < 0.001). The correlation analyses in patient and control groups are shown in Table 2. In addition, the correlations of the LURN SI-10 total score with the IPSS and the OAB-V8 were investigated in male and female participants separately. In all females, a high, positive, and statistically significant correlation between Table 1. Comparison of total scores of the LURN SI-10, IPSS, and OAB-V8 between groups. Total Patient Control AGE Mean (SD) 50.95 (12) 45.24 (16) 1 0.012* SEX n (%) Female 48 (%55.8) 23 (%29.5) 2 0.001* Male 38 (%44.2) 55 (%70.5) Median (IQR) Median (IQR) LURN SI-10 12 (9-18.25) 4 (2.75-6) 3 0.001* IPSS 14 (9-21.25) 5 (2-7) 3 0.001* OAB-V8 21 (12-28) 7 (4.75-9.25) 3 0.001* 1 Student t test; 2 Ki-kare test; 3 Mann Whitney U test; * p < 0.05 Table 2. Correlation of the LURN SI-10 with the IPSS and OAB-V8. Total Patient Control IPSS r 0.761 0.628 0.472 p 0.001* 0.001* 0.001* OAB-V8 r 0.737 0.597 0.490 p 0.001* 0.001* 0.001* Spearman’s correlation; *p < 0.05. Figure 1. Total scores of the LURN SI-10, IPSS and OAB-V8 in groups. Figure 2. Correlation of the LURN SI-10 with the IPSS and OAB-V8. Archivio Italiano di Urologia e Andrologia 2024; 96(2):12415 S. Akan, H. Huseyin Tavukcu, M. Culpan, D. Cella 4 both LURN SI-10 vs IPSS (0.75) and LURN SI-10 vs OAB- V8 (0.79) were observed (p < 0.001). Besides, a high, positive, and statistically significant correlation was found between the LURN SI-10 total score and both IPSS and OAB-VS in the female patient group (p < 0.001). In the female control group, a high, positive, and statistically significant correlation was found between LURN SI-10 total score and OAB-V8 (p < 0.001). In all males, a high, positive, and statistically significant correlation was found between the LURN SI-10 total score and both IPSS and OAB-V8 (78% and 67%, respectively) (p < 0.001). Besides, a high, positive, and statistically significant cor- relation was found between the LURN SI-10 total score and both IPSS and OAB-VS in the male patient group (p < 0.001). In the male control group, a high, positive, and statistically significant correlation was found between LURN SI-10 total score and IPSS (p < 0.001). In the male control group, a low, positive, and statistically significant correlation was found between the LURN SI-10 total score and OAB-V8 (p = 0.031) (Table 3). The reliability of the scale Cronbach’s coefficient of the LURN SI-10 for the internal consistency of the scale was 0.850. Descriptive data and Cronbach’s coefficients of the LURN SI-10, IPSS and OAB-V8 questionnaires are shown in Table 4. DISCUSSION In this study, the validity and reliability assessment of the LURN SI-10 questionnaire in Turkish was performed to make it applicable in patients with LUTS. According to results of our study, version of the LURN SI-10 demon- strated good internal consistency reliability and concur- rent validity, consistent with the results of the original study conducted by LURN group (5). We hope that our study will contribute to standard reporting of symptoms in Turkish-speaking patients and lead to improved evalu- ation of male and female patients with LUTS. Male patients with LUTS usually admit to clinic suffering from differing types of involuntary loss of urine, which are not adequately caught by the IPSS (13). Thus, by using the IPSS solely, these symptoms, which substantial- ly impair the quality of life, could be overlooked and the patient could miss the appropriate counselling opportu- nity. On the other hand, OAB-V8 is an excellent ques- tionnaire for evaluating various types of involuntary loss of urine but cannot assess voiding symptoms if used sole- ly. When compared with other questionnaires, LURN SI- 10, which was validated in Turkish, has several advan- tages. First, it can be applied to both male and female patients with LUTS successfully. In addition, LURN SI-10 completely interrogates incontinence and post-void drib- bling/pain, which are not included in the IPSS, and LUTS such as voiding difficulty, which are not included in the OAB-V8. It can prevent waste of time and effort, for both clinicians and patients, to be able to interrogate all LUTS by application of this questionnaire of only 10 questions without using other scales. In this study, regarding crite- rion-related validity was assessed with associations of LURN SI-10 with IPSS and OAB-V8. It was found that LURN SI-10 was highly correlated with IPSS and OAB-V8 questionnaires (r = .761 and r = .737, respectively). In our results, Cronbach’s alpha internal consistency coefficients of the LURN SI-10, IPSS and OAB-V8 were consistently high (0.850, 0.847, and 0.921, respectively). However, in the control group, internal consistency coef- ficients were notably lower (0.529, 0.616, and 0.613, respectively). These tools clearly perform better as single total scores in clinical samples, an important considera- tion when planning future studies. To the best of our knowledge, this is the first study that assesses the validity and reliability of the LURN SI-10 in a non-English language. Recently, the validity of the LURN SI-10 has been tested by com- paring with the IPSS and its significant correlation has been reported (14). However, that study included only male patients with LUTS. In our study, comparisons with the control group were made for both male and female patients and a significant correlation was demonstrated. A statistically sig- nificant, positive correlation was found between the LURN SI-10 and the IPSS in both groups (p: 0.001). In 2021, the LURN SI-29 was translat- ed into Turkish and its validation was completed by comparing with the IPSS and Urogenital Distress Inventory (UDI- Table 3. The correlations of LURN-10 with IPSS and OAB-VS in females and males. LURN SI‐10 Total Patient Control Female IPSS r 0.754 0.603 0.201 p 0.001* 0.001* 0.358 OAB-V8 r 0.789 0.603 0.648 p 0.001* 0.001* 0.001* Male IPSS r 0.780 0.700 0.572 p 0.001* 0.001* 0.001* OAB-V8 r 0.668 0.580 0.291 p 0.001* 0.001* 0.031* Spearman’s correlation; *p < 0.05. Table 4. Descriptive statistics and Cronbach’s alpha coefficients of the LURN SI-10, IPSS and OAB-V8. n Minimum Maximum Mean ± SD Median Cronbach’s alpha Total LURN SI-10 164 0 29 9.27 ± 6.94 8 0.850 IPSS 164 0 31 10.27 ± 7.74 8 0.847 OAB-V8 164 0 40 13.93 ± 9.64 11 0.921 Patient LURN SI-10 86 3 29 13.56 ± 6.80 12 0.782 IPSS 86 2 31 14.94 ± 7.43 14 0.780 OAB-V8 86 2 40 20.23 ± 0.10 20 0.877 Control LURN SI-10 78 0 12 4.54 ± 2.80 4 0.529 IPSS 78 0 13 5.13 ± 3.83 5 0.616 OAB-V8 78 0 14 6.97 ± 3.47 7 0.613 Archivio Italiano di Urologia e Andrologia 2024; 96(2):12415 5 Turkish version of LURN SI-10 questionnaire 6) (12). However, it was developed for use in clinical studies and outcomes research. Conversely, the LURN SI- 10 was designed as a concise (single-page) form for sim- ple administration in clinical practice. To the best of our knowledge, there is no study investigating the correlation between the LURN SI-10 and OAB-V8 in English litera- ture. In this study, we opted for the OAB-V8, which cov- ers rather storage symptoms, because it was validated in Turkish language in 2012 and has been used for more than ten years in our country. A statistically significant, positive correlation was found between the LURN SI-10 and the OAB-V8 in both patient and control groups (p: 0.001). There are some limitations of this study. We designed the study as a quality improvement initiative to compare the IPSS and OAB-V8 with the LURN SI-10 and for that rea- son main clinical data such as comorbidities, race/ethnic- ity, and body mass index are not included in the present analyses. Moreover, we were not able to attain the age and sex similarity between the patient and control group since this was a pilot study. Further prospective studies, evalu- ating test-retest reliability, the effects of comorbidities, and any changes in answers in LURN SI-10 questionnaire after medical treatment are needed. CONCLUSIONS In this study, the validity and reliability of the LURN SI- 10 questionnaire in Turkish language and its use in patients with LUTS were assessed. This promising meas- urement tool is concise and simple, with initial evidence for reliability and validity in clinical samples and can be used to evaluate LUTS in Turkish women and men. Further studies should be conducted to assess the clinical usefulness of this questionnaire. REFERENCES 1. Irwin DE, Milsom I, Hunskaar S, et al. Population-based survey of urinary incontinence, overactive bladder, and other lower urinary tract symptoms in five countries: results of the EPIC study. Eur Urol. 2006; 50:1306. 2. Selekman RE, Harris CR, Filippou P, et al. Validation of a Visual Prostate Symptom Score in Men With Lower Urinary Tract Symptoms in a Health Safety Net Hospital. Urology. 2015; 86:354-8. 3. Yang CC, Weinfurt KP, Merion RM, et al. Symptoms of Lower Urinary Tract Dysfunction Research Network. J Urol. 2016; 196:146-152. 4. Cella D, Smith AR, Griffith JW, et al. A new outcome measure for LUTS: Symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29) questionnaire. Neurourol Urodyn. 2019; 38:1751-1759. 5. Cella D, Smith AR, Griffith JW, et al. LURN Study Group. A New Brief Clinical Assessment of Lower Urinary Tract Symptoms for Women and Men: LURN SI-10. J Urol. 2020; 203:164-170. 6. Bozlu M, Doruk E, Akbay E, et al. Effect of administration mode (patient vs physician) and patient's educational level on the Turkish version of the International Prostate Symptom Score. Int J Urol. 2002; 9:417-421. 7. Tarcan T, Mangır N, Özgür MO, et al. Constitution and Validation of a New Symptom Assessment Tool for Overactive Bladder: Marmara Overactive Bladder Questionnaire (M-OBQ). Journal of Urological Surgery 2014; 1:24-27. 8. Okamura K, Nojiri Y, Osuga Y, Tange C. Psychometric analysis of international prostate symptom score for female lower urinary tract symptoms. Urology. 2009; 73:1199-202. 9. Coyne K, Revicki D, Hunt T, et al. Psychometric validation of an overactive bladder symptom and health-related quality of life ques- tionnaire: the OAB-q. Qual Life Res. 2002; 11:563. 10. Coyne KS, Zyczynski T, Margolis MK, et al. Validation of an overactive bladder awareness tool for use in primary care settings. Adv Ther 2005; 22:381-94. 11. Tarcan T, Mangır N, Özgür MÖ, Akbal C. OAB-V8 Aşırı Aktif Mesane Sorgulama Formu Validasyon Çalışması. Üroloji Bülteni 2012; 21:113-116. 12. Culpan M, Acar HC, Cella D, et al. Turkish validation and reli- ability of the symptoms of Lower Urinary Tract Dysfunction Research Network Symptom Index-29 (LURN SI-29) questionnaire in patients with lower urinary tract symptoms. Neurourol Urodyn. 2021; 40:2034-2040. 13. Helfand BT, Smith AR, Lai HH, et. al. Prevalence and charac- teristics of urinary incontinence in a treatment seeking male prospec- tive cohort: results from the LURN study. J Urol 2018; 200:397-404. 14. Glaser AP, Kristof TW, Judge C, et al. The 10-item LURN Symptom Index (LURN SI-10) Detects Additional Symptoms and Shows Convergent Validity With the IPSS in Men Presenting With Lower Urinary Tract Symptoms. Urology. 2023; 171:184-189. Correspondence Serkan Akan, MD, Associate Professor (Corresponding Author) drserkanakan@hotmail.com Department of Urology, University of Health Sciences, Fatih Sultan Mehmet Training and Research Hospital, Istanbul, Turkey Hasan Huseyin Tavukcu, MD, Associate Professor hhtavukcu@yahoo.com Department of Urology, Medipol University Camlica Hospital, Istanbul, Turkey Meftun Culpan, MD, Associate Professor mculpan@gmail.com Department of Urology, Faculty of Medicine, Istanbul Medeniyet University, Istanbul, Turkey David Cella, PhD, Professor d-cella@northwestern.edu Department of Medical Social Sciences, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, USA Conflict of interest: The authors declare no potential conflict of interest.