Cardiovascular safety of mirabegron in individuals treated for spinal cord injury- or multiple sclerosis-induced neurogenic detrusor overactivity.

PURPOSE: To analyze cardiovascular safety of mirabegron in patients with spinal cord injury (SCI)- and multiple sclerosis (MS)-induced neurogenic detrusor overactivity (NDO) in a prospective, randomized, double-blind, placebo-controlled study. METHODS: Seventy-eight patients were enrolled into the study, and 66 of them were included into the final analysis. In 49 (74.2%), NDO developed due to suprasacral SCI, 17 (25.8%) suffered from NDO due to MS. Eleven patients were previously treated for hypertension and one for arrhythmia. All study participants received placebo for 2 weeks run-in period. Subsequently, eligible subjects were randomized for 4 weeks of active treatment with mirabegron 50 mg once daily (Group A; n = 32) or placebo (Group B; n = 34). Data from resting electrocardiography (ECG), 24-h ECG and blood pressure monitoring, and echocardiographic examination, were used for cardiovascular safety assessment. All reported variables were evaluated at time of randomization and at the end of the study. Longitudinal changes of variables within the groups and differences between the groups were assessed using nonparametric Kruskal-Wallis test, and p ≤ 0.05 was considered statistically significant. RESULTS: No statistically significant longitudinal changes were found in safety variables, except for prolongation of QT interval in placebo group (p = 0.0328) recorded by resting ECG. No significant difference between the Groups A and B, in any of the variables, was observed. A single cardiovascular study drug-related adverse event was recorded in a patient with cervical SCI (3.13%). CONCLUSIONS: Our results suggest that mirabegron can be safely used in the treatment of patients with SCI- and MS-induced NDO.

Efficacy and safety of mirabegron for the treatment of neurogenic detrusor overactivity-Prospective, randomized, double-blind, placebo-controlled study.

AIMS: To assess the efficacy and safety of mirabegron in the treatment of neurogenic detrusor overactivity. METHODS: This prospective, multicenter, randomized, double-blind, placebo-controlled study was conducted in three tertiary centers, and included 78 patients suffering from spinal cord injury or multiple sclerosis. Patients were randomized for Mirabegron 50 mg (Group A) or placebo (Group B). Urodynamic parameters, the 24 h pad-weight test, and patient-reported outcomes were assessed. Safety assessments included monitoring the incidence and severity of adverse events. Changes in time and differences between groups were assessed with nonparametric Kruskal-Wallis one-way analysis of variance; P ≤ 0.05 was considered statistically significant. RESULTS: In total, 66 patients were eligible for inclusion in the final analysis. There was a significant increase of volume at the first detrusor contraction (P = 0.00047) and an improvement in bladder compliance (P = 0.0041) in the mirabegron group compared with the placebo-treated group, whereas the increase in cystometric capacity did not reach statistical significance (P = 0.061). There was a clear tendency to reduced urine leakage (P = 0.056) in Group A. There were significant changes in all the patient-reported outcomes, favoring the mirabegron group. The incidence of drug-related adverse events was 3.13%. CONCLUSIONS: Mirabegron (50 mg) improved both urodynamic variables and patient-reported outcomes in patients with NDO. The treatment was tolerated well.

The Effects of Diuresis, Duration of Dialysis and Age on Lower Urinary Tract Function in Urologically Healthy Male Patients on the Waiting List for Kidney Transplant.

PURPOSE: This work investigated the effects of diuresis, duration of dialysis and age on lower urinary tract function in urologically healthy males on the waiting list for kidney transplant. MATERIALS AND METHODS: The study included all men who had kidney transplants at our centre between January 2009 and December 2014 who had normal urological findings prior to inclusion on the list. Diuresis, the duration of haemodialysis, age, and parameters of function of the lower urinary tract as determined by filling and voiding cystometry were evaluated. RESULTS: The study included 127 men (median age, 59 years; median diuresis, 250 mL; median duration of dialysis, 469.5 days). We found that greater diuresis was accompanied by significantly higher FDV, FDV/Cmax, NDV,Cmax and compliance and by significantly lower Pdet.max, PdetQmax and BOOI. Longer duration of dialysis was accompanied by significantly lower FDV, NDV and Cmax, compliance and Qmax.p and with significantlyhigher Pdet.max, PdetQmax and BOOI. Older age was associated with significantly higher Pdet.max and with significantly lower compliance. Worsening of the basic parameters of the storage function of the lower urinary tract occurred when diuresis decreased to 500-750 mL, when the duration of dialysis was one year and when patients were older than 54 years. CONCLUSION: In healthy male patients on the waiting list for kidney transplant, there were connections between the occurrence of dysfunctions of the lower urinary tract and diuresis, duration of dialysis and age. Patients should be monitored for dysfunctions of the lower urinary tract before and after transplantation.

The incidence of subclinical forms of urogenital tuberculosis in patients with pulmonary tuberculosis.

The aim of our study was to determine whether patients with pulmonary tuberculosis may have subclinical forms of urogenital tuberculosis. Between 2011 and 2012, a prospective study was conducted. Basic demographic parameters were recorded and the following investigations were performed: direct bacilloscopy of sputum, evaluation of affected lung fields and presence of cavities on chest X-ray, Mantoux tuberculin skin test II, and interferon gamma release assay. Culture and molecular methods for Mycobacterium tuberculosis in urine were performed. In cases with a positive urine test, an ultrasound examination, computed tomography scan of the abdomen, and endoscopy of the urinary tract were performed. A total of 102 patients (75 men and 27 women) were included in the study, with a median age of 46.8 years. Subclinical forms of urogenital TB were detected in 7 patients; 5 by molecular methods, 1 by urine culture, and 1 with both methods The presence of subclinical forms of genitourinary TB was found in 4 patients without and 3 patients with findings on imaging methods corresponding to TB. A significant number of patients with pulmonary tuberculosis may simultaneously have subclinical forms of urogenital TB.