Treatment Patterns with Mirabegron and Antimuscarinics for Overactive Bladder: A Prospective, Registry Study in Taiwan and South Korea (FAITH).

INTRODUCTION: This study aimed to assess overactive bladder (OAB) treatment patterns and factors associated with effectiveness and persistence. METHODS: A prospective, longitudinal, observational registry study of adults starting OAB therapy with mirabegron or antimuscarinics was undertaken. Primary endpoints were time from treatment initiation to discontinuation/switching; proportion who discontinued/switched; and reasons for discontinuation/switching. Secondary endpoints included OAB Symptom Score (OABSS), OAB Questionnaire: Short Form, and OAB Bladder Assessment Tool scores; factors associated with effectiveness and persistence; and safety. RESULTS: In total, 556 patients initiating mirabegron and 250 initiating antimuscarinics were enrolled. There was no treatment switch, change, or discontinuation in 68.5% of the mirabegron initiator group and median time to treatment change was not reached. Mean initial treatment duration was 130.8 days. In multivariable models, baseline OABSS was the only variable significantly associated with change from baseline in OABSS, and patients with mild and moderate OAB had significantly better persistence with mirabegron than those with severe OAB. Urinary tract infection was the most common adverse event with mirabegron. There was no treatment switch, change, or discontinuation in 60.4% of the antimuscarinics initiator group and median time to treatment change was not reached. Solifenacin was the most frequent initial treatment (66.0%). Mean treatment duration was 122.2 days. In multivariable models, baseline OABSS was the only variable significantly associated with change from baseline in OABSS, while patients with OAB medication in the 12 months before enrollment had significantly better persistence with antimuscarinics than those with no previous OAB medication. Dry mouth was the most common adverse event with antimuscarinics. CONCLUSIONS: Mirabegron and solifenacin were commonly prescribed as first-line OAB medications. There was no treatment switch, change, or discontinuation in more than 60% of the mirabegron initiator and antimuscarinics initiator groups. Mean initial treatment duration was 130.8 days and 122.2 days for mirabegron and antimuscarinics, respectively. Graphical Abstract available for this article. TRIAL REGISTRATION: ClinicalTrials.gov NCT03572231.

Safety and efficacy of an α1 -blocker plus mirabegron compared with an α1 -blocker plus antimuscarinic in men with lower urinary tract symptoms secondary to benign prostatic hyperplasia and overactive bladder: A systematic review and network meta-analysis.

AIM: Antimuscarinics and the ß3-adrenoreceptor agonist, mirabegron, are commonly used for treating patients with overactive bladder (OAB) and α1 -adrenoreceptor antagonists (α1 -blockers) are the main pharmacological agents used for treating lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). As these conditions commonly occur together, the aim of this systematic review was to identify publications that compared the use of an α1 -blocker plus mirabegron with an α1 -blocker plus antimuscarinic in men with LUTS secondary to BPH and OAB. A meta-analysis was subsequently conducted to explore the safety and efficacy of these combinations. METHODS: Included records had to be from a parallel-group, randomized clinical trial that was ≥8 weeks in duration. Participants were male with LUTS secondary to BPH and OAB. The indirect analyses that were identified compared an α1 -blocker plus OAB agent with an α1 -blocker plus placebo. The PubMed/Medical Literature Analysis and Retrieval System Online, the Excerpta Medica Database, the Cochrane Central Register of Controlled Trials, and the ClinicalTrials.gov registry were searched for relevant records up until March 5, 2020. Safety outcomes included incidences of overall treatment-emergent adverse events (TEAEs) and urinary retention, postvoid residual volume, and maximum urinary flow (Qmax ). Primary efficacy outcomes were micturitions/day, incontinence episodes/day, and urgency episodes/day, and secondary outcomes were Overactive Bladder Symptom Score and International Prostate Symptom Score. A Bayesian network meta-analysis approach was used for the meta-analysis. RESULTS: Out of a total of 1039 records identified, 24 were eligible for inclusion in the meta-analysis. There were no statistically significant differences between the α1 -blocker plus mirabegron and α1 -blocker plus antimuscarinic groups in terms of the comparisons identified for all the safety and efficacy analyses conducted. Numerically superior results were frequently observed for the α1 -blocker plus mirabegron group compared with the α1 -blocker plus antimuscarinic group for the safety parameters, including TEAEs, urinary retention, and Qmax . For some of the efficacy parameters, most notably micturitions/day, numerically superior results were noted for the α1 -blocker plus antimuscarinic group. Inconsistency in reporting and study variability were noted in the included records, which hindered data interpretation. CONCLUSION: This systematic review and meta-analysis showed that an α1 -blocker plus mirabegron and an α1 -blocker plus antimuscarinic have similar safety and efficacy profiles in male patients with LUTS secondary to BPH and OAB. Patients may, therefore, benefit from the use of either combination within the clinical setting.

A treatment prediction strategy for overactive bladder using a machine learning algorithm that utilized data from the FAITH study.

AIMS: To use machine learning algorithms to develop a model to accurately predict treatment responses to mirabegron or antimuscarinic agents in patients with overactive bladder (OAB), using real-world data from the FAITH registry (NCT03572231). METHODS: The FAITH registry data included patients who had been diagnosed with OAB symptoms for at least 3 months and were due to initiate monotherapy with mirabegron or any antimuscarinic. For the development of the machine learning model, data from patients were included if they had completed the 183-day study period, had data for all timepoints and had completed the overactive bladder symptom scores (OABSS) at baseline and end of study. The primary outcome of the study was a composite outcome combining efficacy, persistence, and safety outcomes. Treatment was deemed "more effective" if the composite outcome criteria for "successful," "no treatment change," and "safe" were met, otherwise treatment was deemed "less effective." To explore the composite algorithm, a total of 14 clinical risk factors were included in the initial data set and a 10-fold cross-validation procedure was performed. A range of machine learning models were evaluated to determine the most effective algorithm. RESULTS: In total, data from 396 patients were included (266 [67.2%] treated with mirabegron and 130 [32.8%] treated with an antimuscarinic). Of these, 138 (34.8%) were in the "more effective" group and 258 (65.2%) were in the "less effective" group. The groups were comparable in terms of their characteristic distributions across patient age, sex, body mass index, and Charlson Comorbidity Index. Of the six models initially selected and tested, the decision tree (C5.0) model was chosen for further optimization, and the receiver operating characteristic of the final optimized model had an area under the curve result of 0.70 (95% confidence interval: 0.54-0.85) when 15 was used for the min n parameter. CONCLUSIONS: This study successfully created a simple, rapid, and easy-to-use interface that could be further refined to produce a valuable educational or clinical decision-making aid.

Prevalence, severity, and associated factors in women in East Asia with moderate-to-severe vasomotor symptoms associated with menopause.

OBJECTIVE: To understand prevalence, severity, impact, and treatment of vasomotor symptoms associated with menopause, using cross-sectional survey data. METHODS: This online, two-part survey was conducted in East Asia among women 40-65 years recruited from established online panels (Edelman, Beijing; Hankook Research, Seoul; Rakuten Insight, Taipei) using stratified sampling. Part I collected demographics/disease characteristics, including menopausal status and vasomotor symptom severity. Women with moderate-to-severe vasomotor symptoms completed Part II, including clinical characteristics, health-related quality of life, and healthcare-seeking behavior. Primary endpoints included vasomotor symptom prevalence and severity and proportions of women eligible and willing to take hormone therapy. Results are presented for each of the three online panels separately and as a pooled total. All analyses are descriptive with no formal hypothesis testing across groups. RESULTS: Numbers of peri- versus postmenopausal women completing Part I were Edelman, 1,588 (55.1% vs 44.9%); Hankook Research, 1,000 (43.6% vs 56.4%); Rakuten Insight, 773 (61.7% vs 38.3%). Vasomotor symptom prevalence was =80% in each region; overall moderate-to-severe vasomotor symptom prevalence was 55%; >50% of women were untreated. Most of those treated used non-prescription treatments. Menopausal hormone therapy use was reported by 11.6% of peri- and 7.2% of postmenopausal women. In peri- and postmenopausal women with moderate-to-severe vasomotor symptoms, 8.6% and 3.4%, respectively, were hormone therapy-willing, 19.3% and 16.8% hormone therapy-contraindicated, 25.4% and 23.0% hormone therapy-cautious, and 10.2% and 8.3% hormone therapy-averse. Women experienced significant burden on health-related quality of life and substantial impairment of work productivity and daily activities. CONCLUSIONS: Vasomotor symptoms associated with menopause affected =80% of women aged 40 to 65 years. A substantial proportion of women are unsuitable for, or choose not to take, menopausal hormone therapy, resulting in an unmet need for nonhormonal treatment options.

Mirabegron Add-On Therapy to Tamsulosin in Men with Overactive Bladder: Post Hoc Analyses of Efficacy from the MATCH Study.

INTRODUCTION: MATCH was a randomized, double-blind, placebo-controlled study enrolling Japanese and Korean men aged ≥ 40 years who still had overactive bladder (OAB) symptoms while receiving tamsulosin. After a 4-week single-blind screening period in which patients received placebo and tamsulosin, patients were randomized to mirabegron 50 mg + tamsulosin or placebo + tamsulosin for 12 weeks (n = 568). This post hoc analysis investigated the proportion of treatment responders for each treatment group and for subgroups stratified by age based on voiding diaries and patient-reported outcomes (PROs). METHODS: Responders were defined as those achieving normalization or clinically meaningful improvements in efficacy, or clinically important differences in PROs [≥ 10-point improvement in OAB questionnaire (OAB-q) symptom bother or total health-related quality of life (HRQoL) subscales at end of treatment (EoT; minimally important difference [MID]) or OAB symptom score (OABSS) total score decreased by ≥ 3 points at EoT [minimally clinically important change (MCIC)]]. RESULTS: At EoT, micturition frequency normalization was achieved by 30.7% of tamsulosin + mirabegron patients and 18.6% of tamsulosin + placebo patients. Normalization of urgency and incontinence was 19.1% and 60.7% for tamsulosin + mirabegron and 18.2% and 60.0% for tamsulosin + placebo. Normalization of OAB symptoms based on OABSS was 17.1% for tamsulosin + mirabegron and 14.5% for tamsulosin + placebo. Higher proportions of patients in the mirabegron add-on group versus the placebo group reported clinically meaningful improvements in micturitions, urgency, and incontinence and in MCIC for OABSS and MID for the OAB-q subscales. Double- and triple-responder findings were as predicted by the results of single-responder analyses. These results were mirrored in the age groups using cut-offs of 65 and 75 years. CONCLUSION: Mirabegron therapy added on to tamsulosin resulted in a higher frequency of responders in terms of normalization (e.g., micturition frequency normalization), clinically meaningful improvements in efficacy (e.g., ≥ 50% decrease in urgency), and minimally important changes in PROs (e.g., MCIC in OABSS). TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02656173.

Safety of Tacrolimus in Autoimmune Disease: Results From Post-marketing Surveillance in South Korea.

Objective: Tacrolimus, a macrolide immunosuppressant, is approved in Korea for the treatment of rheumatoid arthritis (RA), lupus nephritis (LN) and myasthenia gravis (MG) We report three prospective post-marketing surveillance studies of tacrolimus conducted in South Korea in these indications. Methods: Studies were conducted according to South Korean Ministry of Food and Drug Safety requirements Patients were followed up for the duration of the study (up to 4 years) or until treatment discontinuation Occurrence and likely relationship with tacrolimus of adverse events (AEs), adverse drug reactions (ADRs; defined as AEs where causal relationship to tacrolimus could not be excluded) and serious AEs were recorded Association of AEs with demographic and medical factors was evaluated by multivariable analysis. Results: The studies included 740 (RA), 307 (LN) and 104 (MG) patients The incidence of AEs was 127% in RA (642% of AEs potentially related to tacrolimus), 209% (378% potentially related) in LN and 298% (568% potentially related) in MG The incidence of ADRs was 84%, 98% and 202%, respectively Serious AEs were reported in 07%, 72% and 87%, respectively The most common AEs were abdominal pain (RA), pharyngitis (LN) and diarrhea (MG) Unexpected AEs occurred in 35% of patients with RA, 29% in LN and 87% in MG; no pattern of unexpected AEs was apparent Multivariable analysis demonstrated that patients with comorbidity had higher probability of experiencing an AE in RA and MG studies. Conclusion: The incidence of AEs and the safety profile of tacrolimus in each indication was consistent with previous reports.

Cardiovascular safety of mirabegron add-on therapy to tamsulosin for the treatment of overactive bladder in men with lower urinary tract symptoms: A post hoc analysis from the MATCH study.

OBJECTIVES: To investigate the cardiovascular safety of mirabegron add-on treatment to tamsulosin in male patients with residual overactive bladder symptoms. METHODS: This was a post hoc analysis of MATCH, the first double-blind, placebo-controlled study comparing mirabegron and placebo as add-on therapy to tamsulosin for treatment of overactive bladder in men with lower urinary tract symptoms. The analysis focused on treatment-emergent adverse events relating to the cardiovascular system or blood pressure, and changes in vital signs during 12 weeks of follow-up. RESULTS: Cardiovascular-related treatment-emergent adverse events were reported by 6/566 patients, although only one serious treatment-emergent adverse event was related to treatment (unstable angina in the tamsulosin + placebo group). Hypertension (two patients) and increased blood pressure (one patient) were reported in the tamsulosin + placebo group, but there were no blood pressure-related treatment-emergent adverse events among tamsulosin + mirabegron patients. There were no clinically meaningful changes from baseline in blood pressure, and changes in pulse rate were small (+1.2 bpm in the tamsulosin + mirabegron group). Increased pulse rate was more frequent with tamsulosin + mirabegron than with tamsulosin + placebo in older patients, although within the normal range. CONCLUSIONS: Cardiovascular-related adverse events were uncommon in both treatment groups. Mirabegron is a well-tolerated add-on therapy to tamsulosin in Japanese and Korean males with residual overactive bladder symptoms.

The prevalence of urinary incontinence in men and women aged 40 years or over in China, Taiwan and South Korea: A cross-sectional, prevalence-based study.

OBJECTIVES: To assess prevalence of urinary incontinence (UI), including urgency UI (UUI), stress UI (SUI) and mixed UI (MUI) in individuals aged ≥40 years in China, Taiwan and South Korea. METHOD: This was a post hoc analysis of a cross-sectional, questionnaire-based internet survey. Participants were asked questions relating to urinary symptoms, health-related quality of life (HRQoL) and mental health (using the HRQoL 12-item short form health survey mental health and physical domains, and the Hospital Anxiety and Depression Scale), visits to healthcare professionals (HCPs) for any reason or for urinary symptoms, treatments for urinary symptoms and treatment satisfaction. RESULTS: Of 8284 survey participants, 1818 (22%) reported any UI (men 17.3%, women 26.4%). MUI was the most prevalent (overall 9.7%, men 6.8%, women 12.6%) followed by SUI (overall 7.9%, men 5.1%, women 10.7%) and UUI (overall 4.3%, men 5.5%, women 3.2%). HRQoL, anxiety and depression scores were poor in all participants with UI; MUI was associated with the worst scores. Of the participants with UI, 46.9% visited HCPs for urinary symptoms (highest proportion [62.7%] among participants with MUI). Approximately 80% of participants with UI followed treatment, with prescribed medicine being the most common form (38.1%). Over half of participants (59.6%) were somewhat, very, or extremely satisfied with their treatment. MUI was associated with least satisfaction. CONCLUSION: UI was associated with substantial problems, including an adverse impact on HRQoL. Medication failed to satisfy many individuals with UI. Efforts to educate the public and physicians about the impact of UI could improve diagnosis and treatment rates.

Mirabegron Add-on Therapy to Tamsulosin for the Treatment of Overactive Bladder in Men with Lower Urinary Tract Symptoms: A Randomized, Placebo-controlled Study (MATCH).

BACKGROUND: Men with lower urinary tract symptoms (LUTS) treated with α-blockers (eg, tamsulosin) may experience overactive bladder (OAB) symptoms and receive add-on antimuscarinics. Mirabegron (a ß3-adrenoreceptor agonist) is an alternative add-on therapy. OBJECTIVE: To evaluate the efficacy of mirabegron versus placebo in men with OAB symptoms receiving tamsulosin for LUTS. DESIGN, SETTING, AND PARTICIPANTS: Japanese and Korean men with OAB treated with tamsulosin for LUTS (January 2016-July 2017). INTERVENTION: Single-blind, 4-wk screening: tamsulosin plus placebo orally once daily; double-blind, 12-wk treatment: patients randomized (n=568) to mirabegron 50mg or placebo, as add-on to tamsulosin. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Primary endpoint: baseline to end of treatment (EoT) change in the mean number of micturitions/24h, based on a 3-d voiding diary. Secondary endpoints: change in other diary variables and patient-reported outcomes from baseline to EoT. The primary endpoint was analyzed by analysis of covariance, including treatment group and region as fixed factors and baseline as a covariate. RESULTS AND LIMITATIONS: Mirabegron add-on therapy was superior to placebo in improving the primary endpoint (adjusted mean difference [95% confidence interval] vs placebo -0.52 [-0.82 to -0.21]) and secondary endpoints, including mean volume voided/micturition (12.08 [6.33-17.84]), OAB symptom score (-0.65 [-1.04 to -0.26]), International Prostate Symptom Score total (-1.19 [-1.94 to -0.44]), storage (-0.78 [-1.13 to -0.43]), quality of life scores (-0.29 [-0.51 to -0.07]), OAB symptom bother (-4.52 [-6.91 to -2.13]), and total health-related quality of life (2.79 [1.13 to 4.44]). Differences, compared with placebo, in urgency, urgency urinary incontinence, and nocturia were not statistically significant. Mirabegron was well tolerated, with no major safety concerns. Limitations included a lack of antimuscarinic comparison. CONCLUSIONS: The mirabegron add-on therapy to tamsulosin for 12 wk in men with LUTS and OAB symptoms demonstrated superior efficacy to placebo and was well tolerated. PATIENT SUMMARY: We looked at the efficacy and safety of mirabegron compared with placebo in men being treated with tamsulosin but who still had overactive bladder symptoms. Mirabegron improved overactive bladder symptoms and patient-reported outcomes compared with placebo, and was well tolerated.

Effect of lower urinary tract symptoms on the quality of life and sexual function of males in China, Taiwan, and South Korea: Subgroup analysis of a cross-sectional, population-based study.

OBJECTIVE: Lower urinary tract symptoms (LUTS) in males can reduce patients' quality of life (QoL) and affect sexual function and satisfaction. Although this has been documented in the US, Canada, Germany, Italy, UK, and Sweden, data are limited on the effects of LUTS on QoL and sexual function in Asian men. The present subgroup analysis of an Internet-based survey correlated the incidence of male LUTS by severity and category with self-assessed QoL and sexual function and satisfaction measures. METHODS: Males aged ≥40 years were randomly selected from consumer survey panels in China, Taiwan, and South Korea. LUTS were defined using the International Continence Society (ICS) 2002 symptom definitions; symptom severity was assessed by the International Prostate Symptom Score (IPSS). The effect of LUTS on QoL was assessed using Patient Perception of Bladder Condition (PPBC) and IPSS QoL scores. Sexual function and satisfaction were assessed using the International Index of Erectile Function (IIEF). RESULTS: Men with moderate-to-severe LUTS and overlap of voiding, storage, and post-micturition symptom categories reported dissatisfaction with their QoL and sexual function. LUTS severity was negatively correlated with IIEF scores. Overlap of LUTS categories had a greater effect on QoL and sexual satisfaction than the incidence of just 1 LUTS. CONCLUSION: The findings of the present study suggest that LUTS is prevalent in >60% of Asian males aged ≥40 years and is associated with reduced QoL and sexual function, particularly in those with overlap of LUTS categories and greater symptom severity.

Prevalence of overactive bladder in China, Taiwan and South Korea: Results from a cross-sectional, population-based study.

OBJECTIVE: The aim of the present study was to determine the prevalence of overactive bladder (OAB) in individuals aged ≥40 years in China, Taiwan, and South Korea. METHODS: The present cross-sectional population-representative Internet-based study investigated OAB symptoms in men and women aged ≥40 years using the overactive bladder symptom score. Additional instruments included the International Index of Erectile Function (men only) and the Sexual Quality of Life - Female (women only) questionnaires, as well as Patient Perception of Bladder Condition (PPBC). RESULTS: In all, 8284 individuals participated in the study. The prevalence of OAB was 20.8% overall (women 22.1%, men 19.5%) and increased significantly with age, from 10.8% in those aged 40-44 years to 27.9% in those aged >60 years (P = .001). The presence of comorbid conditions (e.g. neurological disease, diabetes) was associated with a significantly increased prevalence of OAB. Increasing symptom severity was associated with significantly worsening patient perception of bladder condition responses. Just under half (48%) of those with no OAB had no lower urinary tract symptoms (LUTS), whereas 88% of those with severe symptoms had all 3 LUTS (International Continence Society definition) symptom categories (voiding, post-micturition, and storage symptoms). Of those without OAB, 10% reported visiting healthcare professionals for urinary symptoms, compared with 64% of those with severe OAB symptoms (P = .001). Increased symptom severity was significantly associated with lower sexual quality of life in both men and women. CONCLUSIONS: OAB symptoms were found to affect 1 in 5 individuals aged ≥40 years in China, Taiwan, and South Korea, becoming more common with increasing age. The results suggest that many more individuals with OAB could benefit by consulting healthcare professionals.

The prevalence and bother of lower urinary tract symptoms in men and women aged 40 years or over in Taiwan.

BACKGROUND/PURPOSE: The prevalence of lower urinary tract symptoms (LUTS) in men and women in the general population in Taiwan is unclear. Community-based data on the epidemiology and effects of LUTS would therefore help improve understanding of the condition in this country. METHODS: This study was an internet-based, self-administered survey, conducted in randomly selected adults aged ≥40 years. Participants answered questions on International Continence Society (ICS) symptom definitions, the International Prostate Symptom Score (IPSS) and the overactive bladder (OAB) symptom score. RESULTS: The study population comprised 2068 adults (51.4% women) with a mean age of 55 years. Using criteria from the ICS, LUTS were present in 60% of men and 57% of women. The prevalence of LUTS increased with age in both men and women. The most bothersome symptoms were terminal dribble, incomplete emptying and nocturia in men, and nocturia, perceived frequency and urgency in women. In the overall population, according to IPSS, 30% had at least moderate symptoms. OAB prevalence was 16% in both men and women. The likelihood of consulting a healthcare professional about urinary symptoms was low and not significantly different between men and women with LUTS (17% and 14%, respectively). CONCLUSION: More than half of men and women aged ≥40 years in Taiwan are affected by LUTS, and these symptoms are often bothersome. However, few individuals with LUTS consult healthcare professionals about their symptoms. Improved diagnosis and treatment of LUTS in Taiwan are needed to reduce the deleterious effects of the condition. CLINICALTRIALS. GOV IDENTIFIER: NCT02618421.

Epidemiology of lower urinary tract symptoms in a cross-sectional, population-based study: The status in China.

Lower urinary tract symptoms (LUTS) are reported to affect over half of all adults, and they are associated with significantly impaired quality of life (QOL). We performed a population-based study to evaluate the overall prevalence and impact of LUTS including overactive bladder (OAB) in adults aged ≥40 years in China.Adults aged ≥40 years were eligible to participate in this internet-based survey, provided that they had the ability to access the internet, to use a computer and to read the local language. The survey contained questions relating to International Continence Society (ICS) symptom definitions, the International Prostate Symptom Score (IPSS) and the Overactive Bladder Symptom Score (OABSS). The primary study objective was to determine the prevalence of LUTS using the ICS 2002 symptom definition.Among the 4136 respondents, 2080 (50.3%) were men and 1347 (32.6%) were aged ≥60 years. LUTS prevalence according to ICS criteria was 60.3% in men and 57.7% in women. All 3 ICS symptom groups (voiding, storage, and postmicturition) were present in 22.8% of women and 24.2% of men, making this the most common combination of ICS symptom groups. The most bothersome symptoms were terminal dribble and nocturia. According to IPSS scores, 32.9% of participants had at least moderate symptoms. The prevalence of OAB was 23.9%. The presence of LUTS-particularly all 3 ICS symptom groups-was associated with reduced sexual QOL in women, reduced satisfaction with erectile function in men, higher anxiety and depression scores, and reduced health-related QOL (physical health and mental health domains). The overall percentage of participants with LUTS visiting healthcare professionals for urinary symptoms was 38%.In conclusion, LUTS affect the majority of adults aged ≥40 years in China, and prevalence increases with increasing age. LUTS are associated with impaired QOL and mental health, but fewer than half of individuals in China with LUTS seek healthcare for their symptoms. There is therefore a need to improve awareness and treatment of the condition.ClinicalTrials.gov identifier: NCT02618421.

The prevalence of lower urinary tract symptoms in population aged 40 years or over, in South Korea.

Purpose: Lower urinary tract symptoms (LUTS) can be distressing and socially isolating, and the economic impact can be substantial. Further data to characterize the epidemiology and effects of LUTS in South Korea would be beneficial. Materials and Methods: In an international, internet-based survey, the prevalence and impact of LUTS was evaluated in adults aged ≥40 years. Questions related to International Continence Society (ICS) symptom definitions and the bother associated with each symptom. The international prostate symptom score (IPSS) and the overactive bladder symptom score (OABSS) were assessed. Results: Of the 2,080 participants from South Korea, 1,090 (52.4%) were women and 740 (35.6%) were aged ≥60 years. The prevalence of LUTS according to ICS criteria was 68.2% (men, 70.6%; women, 66.0%). LUTS prevalence increased significantly with age (p=0.01 in men and women). Storage symptoms only were reported in 16.2% of men and 30.5% of women, making this the most common ICS symptom group overall. Individual symptoms with the highest prevalence in the overall population were nocturia, frequency, and weak stream (36%, 30%, and 29%, respectively). IPSS results showed that 40.1% of participants had at least moderate symptoms. The prevalence of OABSS-defined overactive bladder was 19.7% (men, 19.5%; women, 19.9%). Fourteen percent of individuals with any LUTS visited healthcare professionals regarding urinary symptoms. Conclusions: LUTS affect the majority of adults aged ≥40 years in South Korea. The low percentage of individuals with LUTS consulting healthcare professionals regarding urinary symptoms indicates a need to improve rates of diagnosis and treatment.

The prevalence and risk factors of nocturia in China, South Korea, and Taiwan: results from a cross-sectional, population-based study.

PURPOSE: To examine the prevalence, symptomatology, and risk factors for nocturia using data from an internet-based questionnaire conducted in China, South Korea, and Taiwan. METHODS: Data from a cross-sectional, population-representative, internet-based study conducted among men and women aged ≥ 40 years were analysed post hoc. Nocturia prevalence and bother were analysed by sex and age group, and with regard to comorbid conditions and lower urinary tract symptoms (LUTS). Multivariate and univariate logistic regression models to identify risk factors for nocturia were constructed, with nocturia involving ≥ 2 nocturnal voids as the dependent variable. RESULTS: Among the 8284 participants, the prevalence of nocturia involving ≥ 1, ≥ 2, or ≥ 3 voids was slightly higher for women (76.1, 37.3, and 17.5%, respectively) compared with men (74.0, 34.5, and 15.5%, respectively). The prevalence and associated bother of nocturia increased with age. Greater proportions of patients with comorbid conditions or wet/more severe overactive bladder syndrome (OAB) experienced nocturia than those without. Multivariate analysis identified that female sex, age > 60 years, diabetes, cardiac disease, body mass index, International Prostate Symptom Score (IPSS) voiding score, stress urinary incontinence, wet OAB, and Hospital Anxiety And Depression Scale (HADS) anxiety score were associated with ≥ 2 nocturnal voids. Hypertension was associated with ≥ 2 nocturnal voids in women but not men, and alcohol consumption in men but not women. CONCLUSIONS: Nocturia is a common and bothersome condition affecting a large proportion of men and women aged ≥ 40 years in China, South Korea, and Taiwan. Factors associated with nocturia included age, sex, comorbid conditions, and LUTS. TRIAL REGISTRATION: This study is registered at ClinicalTrials.gov: NCT02618421.

Association of lower urinary tract symptoms and OAB severity with quality of life and mental health in China, Taiwan and South Korea: results from a cross-sectional, population-based study.

BACKGROUND: Lower urinary tract symptoms (LUTS) and overactive bladder (OAB) symptoms have a substantial effect on quality of life (QoL). We report QoL and mental health results from a LUTS prevalence study in three Asian countries. METHODS: A cross-sectional, population-representative, internet-based study among individuals aged ≥40 years in China, Taiwan and South Korea. Instruments included: Overactive Bladder Symptom Score (OABSS); International Prostate Symptom Score (IPSS); other International Continence Society (ICS) symptom questions; health-related QoL 12-item short-form (HRQoL-SF12v2); Work Limitations Questionnaire (WLQ); Hospital Anxiety and Depression Scale (HADS). Presence of LUTS was determined according to ICS criteria, with three symptom groups (storage, voiding and post-micturition). Post-stratification weighting matched the age and sex population distribution per country. Initial data analyses were based on descriptive statistics. Significance testing undertaken post hoc included: independent-samples t-test (differences in HRQoL between sexes and between individuals with/without LUTS; relationship between HRQoL score and OABSS; differences in HADS anxiety and depression scores between individuals with/without LUTS; association between HADS anxiety/depression scores and OABSS), chi-square test (association between LUTS prevalence and workplace productivity) and analysis of variance (differences in HRQoL score and in HADS anxiety/depression scores between individuals with different symptom groups, association between HADS anxiety/depression scores and IPSS). RESULTS: In total, 8284 participants were included. HRQoL scores were significantly worse (p < 0.001) among individuals with versus without LUTS (ICS criteria): mean physical health domain scores were 61.1 (standard deviation [SD], 20.1) and 76.7 (17.0), respectively; corresponding mental health domain scores were 34.8 (12.7) and 43.7 (10.7). Workplace productivity was best among individuals without LUTS (difficulties reported by 2-3% of individuals), and worst in those with all three ICS symptom groups (difficulties reported by 29-38% of individuals; p = 0.001). Mean HADS scores showed significantly worse (p < 0.001) levels of anxiety and depression among individuals with versus without LUTS: anxiety, 6.5 (SD, 3.7) and 4.0 (3.3); corresponding mean depression scores were 6.8 (4.3) and 4.2 (3.6). Increasing OAB severity was also associated with decreasing HRQoL physical and mental health scores. CONCLUSION: LUTS and increasing OAB severity are both associated with impaired QoL, reduced workplace productivity, and increased tendency towards anxiety and depression. These results highlight the need to ensure that individuals with LUTS receive appropriate, effective treatment. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02618421 , registered 26 November 2015 (retrospectively registered).

Prevalence of Lower Urinary Tract Symptoms in China, Taiwan, and South Korea: Results from a Cross-Sectional, Population-Based Study.

INTRODUCTION: Few population-based data are available evaluating the prevalence of lower urinary tract symptoms (LUTS) in Asia. The objective of our study was to determine LUTS prevalence in China, Taiwan, and South Korea using International Continence Society (ICS) 2002 criteria. METHODS: An Internet-based self-administered survey among individuals aged at least 40 years with the ability to use a computer and to read the local language. Survey questions included ICS symptom definitions and the international prostate symptom score (IPSS). Data analysis was based on descriptive statistics and post hoc significance testing. RESULTS: There were 8284 participants, of whom 51% were women and 34% were aged at least 60 years. LUTS prevalence was slightly higher in men than women (62.8% vs. 59.6%; p = 0.004), increasing significantly with age (p = 0.001). All three ICS symptom groups (voiding, storage, and post-micturition) were present in 35% of individuals with LUTS. Symptoms with the highest overall prevalence were nocturia, frequency, incomplete emptying, and terminal dribble. The most bothersome symptoms were terminal dribble, nocturia, and urgency. According to IPSS scores, 87% of participants had at least mild symptoms; 43% of those aged over 60 years had moderate/severe symptoms. The percentage of participants with any LUTS who had visited healthcare professionals because of urinary symptoms was 26%, rising to 45% amongst individuals with all three symptom groups (p = 0.001 vs. other ICS symptom groups). CONCLUSIONS: LUTS are highly prevalent in men and women aged at least 40 years who participated in this study in China, Taiwan, and South Korea and increases with increasing age. A minority of individuals with LUTS seek healthcare and our results suggest an increased patient awareness of LUTS is required. FUNDING: Astellas Pharma Singapore Pte. Ltd. TRIAL REGISTRATION: ClinicalTrials.gov identifier, NCT02618421.