Development,validation And Application Of The Chinese Version Of International Consultation On Incontinence Modular Questionnaire For Male Lower Urinary Tract Symptoms(ICIQ-MLUTS)and ICIQ-MLUTS Long Form

BackgroundAccording to the definition proposed by International Continence Society(ICS),lower urinary tract symptoms(LUTS)can be divided into storage,voiding and post-micturition symptoms.LUTS have aroused extensive attention due to raising awareness of their adverse effects on quality of life.To quantify the symptoms and bother,follow up group of patients and assess treatment outcomes better,scale was highly regarded by European Association of Urology(EAU)and American Urological Association(AUA).International Consultation on Incontinence Modular Questionnaire for Male Lower Urinary Tract Symptoms(ICIQ-MLUTS)and ICIQ-MLUTS long form(ICIQ-MLUTS LF)were developed to provide high quality,international standard questionnaires and facilitate the communication and comparison of associated research.ICIQ-MLUTS was developed based on the definition of LUTS proposed by ICS,and was awarded“strong”recommendation by EAU Guidelines on Management of Non-Neurogenic Male Lower Urinary Tract Symptoms.The original version of ICIQ-MLUTS has been translated into many other languages worldwide and has been fully validated for use.However,Chinese versions of ICIQ-MLUTS and ICIQ-MLUTS LF have not existed yet.Objective1.To translate the International Consultation on Incontinence Modular Questionnaire for Male Lower Urinary Tract Symptoms(ICIQ-MLUTS)and ICIQ-MLUTS long form(ICIQ-MLUTS LF)into Chinese and analyze their validity and reliability.2.To propose the severity categories of ICIQ-MLUTS long form and investigate the diagnostic value of voiding-to-storage subscore ratio of ICIQ-MLUTS long form.3.To assess the applicability of ICIQ-MLUTS long form in benign prostate hyperplasia(BPH)patients before and after minimally invasive surgery.Methods1.After obtaining permission from the International Consultation on Incontinence Modular Questionnaire(ICIQ),original ICIQ-MLUTS and ICIQ-MLUTS LF were translated into Chinese according to ICIQ validation protocol and cultural adaptation guideline.During November 2017 to August 2018,Chinese version of ICIQ-MLUTS and ICIQ-MLUTS LF were tested by administering them in respectively 6 and 12 hospitals in China.To validate the metric properties of translated questionnaires,the following tests were undertaken.Content validity and criterion validity were used to assess validity of scales,and the reliability was evaluated by internal consistency and test-retest reliability.2.230 male patients with lower urinary tract symptoms were enrolled in the research above to complete the ICIQ-MLUTS LF and International Prostate Symptom Score(IPSS).Based on the generally recognized severity categories of IPSS and the diagnostic value of its voiding-to-storage subscore ratio,receiver operating characteristics(ROC)curves were constructed for the development of severity categories of ICIQ-MLUTS LF and the cut-off value of its voiding-to-storage subscore ratio.3.BPH patients who met the criteria for inclusion and underwent minimally invasive surgery in Nanfang Hospital were selected for investigation from May 25,2018 to January 28,2019.The ICIQ-MLUTS LF was completed before and 1 month after surgery,and the data was compared.Results1.In total,Chinese ICIQ-MLUTS and ICIQ-MLUTS LF were administrated to respectively 135 and 230 male patients with lower urinary tract symptoms.Considering the feedback of in-depth interviews with participants and experts,both questionnaires had good content validity.They had good criterion validity with IPSS(Pearson correlation 0.846 and 0.833 for ICIQ-MLUTS and ICIQ-MLUTS LF,respectively,both P<0.001).The Cronbach's alpha coefficient was 0.797 for ICIQ-MLUTS and 0.853 for ICIQ-MLUTS LF,and Intraclass correlation coefficient was 0.986 and 0.985 respecti-vely(both/P<0.001),showing satisfactory reliability.2.The ICIQ-MLUTS long form may be divided into the following severity categories:slight(1-19),moderate(20-27)and severe(28-84).An ICIQ-MLUTS LF voiding-to-storage subscore ratio of 1.5 may separate the distribution of voiding dysfunction and storage dysfunction.3.Significant difference could be found in ICIQ-MLUTS LF total score and the scores of its voiding domain,storage domain,post-voiding domain,urge incontinence item,bladder pain item,dysuria item,frequency plus nocturia items before and after treatment in BPH patients(P<0.05).Nevertheless,there was no significant difference in the scores of incontinence domain and stress incontinence item of ICIQ-MLUTS LF before and after treatment(P>0.05).Conclusions1.The Chinese version of ICIQ-MLUTS and ICIQ-MLUTS LF had good validity and reliability,which can be used to assess Chinese male patients with lower urinary tract symptoms.2.The severity categories and voiding-to-storage subscore ratio of ICIQ-MLUTS LF may provide a guide for the initial treatment.3.ICIQ-MLUTS LF is a detailed and reliable tool for Chinese BPH patients who undergo minimally invasive surgery.