RESUMO
PURPOSE: The purpose of this study is to investigate the efficacy and safety of mirabegron versus solifenacin in the treatment of newly diagnosed overactive bladder (OAB) in children. METHODS: We conducted a prospective randomized controlled study on pediatric patients with newly diagnosed OAB. Patients were randomized into 3 groups: mirabegron (50 mg once daily) in group I, solifenacin (5 mg) in group II, and placebo in group III. Before starting our treatment and at the end of the 3 months course, we obtained a 3-day voiding diary. This diary included incontinence episode per day, mean voided volume per micturition, mean number of micturition per day, and post-void residual urine. Moreover, the parents/patients were asked to rate symptom relief, and the adverse events were recorded throughout the study period. RESULTS: A total of 190 patients aged from 5 to 14 years completed this study. At the end of this trial, both groups I and II showed significant improvement versus placebo regarding our efficacy parameters with no significant difference between group I and II. The overall success rate based on assessment of symptom relief was significantly higher in the treated groups (87.5% in I and 90.2% in II) versus placebo (55.8%). Dry mouth was reported in 2.8, 10, and 0% and constipation in 2.8, 11.4, and 1.4% in group I, II, and III, respectively, without statistically significant difference between group I and placebo. However, there was a significant difference between group II and placebo regarding these side effects. CONCLUSION: Both mirabegron and solifenacin have comparable efficacy regarding the control of OAB symptoms in the newly diagnosed children, but mirabegrone seems to have less side effects.
Assuntos
Acetanilidas/uso terapêutico , Agonistas de Receptores Adrenérgicos beta 3/uso terapêutico , Antagonistas Muscarínicos/uso terapêutico , Succinato de Solifenacina/uso terapêutico , Tiazóis/uso terapêutico , Bexiga Urinária Hiperativa/tratamento farmacológico , Bexiga Urinária/efeitos dos fármacos , Urodinâmica/efeitos dos fármacos , Agentes Urológicos/uso terapêutico , Acetanilidas/efeitos adversos , Adolescente , Agonistas de Receptores Adrenérgicos beta 3/efeitos adversos , Fatores Etários , Criança , Pré-Escolar , Egito , Feminino , Humanos , Masculino , Antagonistas Muscarínicos/efeitos adversos , Estudos Prospectivos , Método Simples-Cego , Succinato de Solifenacina/efeitos adversos , Tiazóis/efeitos adversos , Fatores de Tempo , Resultado do Tratamento , Bexiga Urinária/fisiopatologia , Bexiga Urinária Hiperativa/diagnóstico , Bexiga Urinária Hiperativa/fisiopatologia , Agentes Urológicos/efeitos adversosRESUMO
INTRODUCTION: Alpha-adrenergic blockers are now the cornerstone medication in management of lower urinary tract symptom (LUTS); however, the associated treatment-related abnormal ejaculation could be a bothersome event. This is a comparative study among different methods of tamsulosin administration in terms of efficacy, recoverability of ejaculatory function, and quality of life (QoL) in men with tamsulosin-related abnormal ejaculation. PATIENTS AND METHODS: Sexually active men receiving tamsulosin for LUTS who were bothered by treatment-related abnormal ejaculation following initiation of tamsulosin were randomized into 3 groups; group A received intermittent-full-standard-dose, group B received low-dose-tamsulosin, and group C received full-standard-dose tamsulosin The status of ejaculatory function, IPSS, QoL score, and Q-Max were measured at baseline and 3 months later. RESULTS: A total of 93 men with mean age of 53.1 years were included in the study, 3-months after randomization, statistically significant improvements in IPSS, QoL index, and Q-Max in comparison to pre-treatment levels were noted. Restoration of normal ejaculation was reported by 74.1 and 90.3% of patients in group A and B, respectively, versus none in group C. The QoL score was significant when comparing group A to the other groups; finally, the Q-Max was significant when comparing group C to the other groups. CONCLUSION: For patients bothered by tamsulosin-related abnormal ejaculation, a significant improvement in the QoL, without deviation from the therapeutic purpose of treatment, can be achieved by administration of 0.4 mg tamsulosin every other day.