Efficacy and safety of mirabegron in children and adolescents with neurogenic detrusor overactivity: An open-label, phase 3, dose-titration study.

Aims: To evaluate the efficacy and safety of mirabegron in children and adolescents (aged 3 to <18 years) with neurogenic detrusor overactivity (NDO) using clean intermittent catheterization.

Methods: In this open-label, multicenter, baseline-controlled, Phase III study (NCT02751931), participants received once-daily mirabegron at an adult dose equivalent of 25 mg. Dose was increased to 50 mg equivalent unless there were safety/tolerability concerns.

Long-term efficacy and safety of solifenacin in pediatric patients aged 6 months to 18 years with neurogenic detrusor overactivity: results from two phase 3 prospective open-label studies.

Introduction: The standard recommended treatment for neurogenic detrusor overactivity (NDO) is clean intermittent catheterization combined with an antimuscarinic agent. However, the adverse systemic side-effects of oxybutynin, the most widely used agent, are of concern.

Objective: To evaluate the efficacy and safety of solifenacin in pediatric patients with NDO, aged 6 months-<5 years and 5-<18 years.

The pharmacokinetics, safety, and tolerability of mirabegron in children and adolescents with neurogenic detrusor overactivity or idiopathic overactive bladder and development of a population pharmacokinetic model-based pediatric dose estimation.

Introduction: Mirabegron, a selective β3-adrenoreceptor agonist, is a well-established alternative to antimuscarinics in adults with overactive bladder (OAB) symptoms and is under development for use in pediatric patients. Understanding drug pharmacokinetics (PK) in pediatric patients is needed to determine appropriate dosing. Conducting these studies is ethically complex, particularly as regulatory guidance requires that PK is assessed in pediatric patients with a therapeutic need for the drug.

The risk of neoplasm associated with dysgenetic testes in prepubertal and pubertal/adult patients.

Introduction: In patients with Y-chromosome in the karyotype, partial gonadal dysgenesis and disorders of male reproductive sex organs development are usually resected in childhood because of the high risk of germ cell tumours (GCT). In patients with Y-chromosome, complete gonadal dysgenesis and female genitalia gonadectomy is performed markedly later. However, due to the relatively low number of adult patients with preserved dysgenetic gonads, the true risk of neoplasm is unknown.

Complications after primary bladder exstrophy closure - role of pelvic osteotomy.

Introduction: Bladder exstrophy is the most common form of the exstrophy - epispadias complex. It is observed in 1:30 000 life births, about four times more often in boys than in girls. Iliac osteotomy is used to facilitate bringing together pubic bones and to minimize the tension of fused elements.

[Urinary tract infections in children by pediatric urologist].

Urinary tract infection (UTI) is the most common infection disease in all age. From the pediatric urology point of view, difficulty in bladder emptying is the most favorable factor for UTI. Early ultrasonographic (USG) investigation is necessary to detect urinary obstruction and urolithiasis.

Bladder augmentation and continent urinary diversion in boys with posterior urethral valves.

Posterior urethral valve (PUV) is a condition that leads to characteristic changes in the bladder and upper urinary tract. Dysfunction of the bladder such as a hyperreflective, hypertonic, and small capacity bladder as well as sphincter incompetence and/or myogenic failure should be adequately treated. Poor compliance/small bladder could be treated with anticholinergics, but bladder augmentation will probably be indicated.

[Vesicoureteral reflux and urinary tract infections].

Understanding the role of urodynamic conditions in the bladder with vesicoureteral reflux (VUR) have changed the cause-effect relationship between vesicoureteral reflux and urinary tract infections (UTI) in children. It is not a presence of UTI itself that decides on VUR appearance but accompanying voiding dysfunction. Dysfunctional voiding causes functional urinary tract obstruction which increases intravesical pressure during storage and voiding, and contributes post-voiding residuals.

[Urinary tract infections--pediatric urologist point of view].

Urinary tract infections (UTI) could present with different clinical forms dependent on intensity and localization of infection and child's age. The symptoms could be non specific in children. Condition that provoke to urinary stasis, especially voiding dysfunction is the favourable factor for UTI appearance.