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.

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.

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.

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.