Conditions: Neurogenic Urinary Bladder
Keywords: child bladder neuropathic alpha blockers
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 172
Healthy volunteers: no

Brief summary:
The primary objective of the study was to evaluate the efficacy of Alfuzosin in comparison to Placebo on the detrusor Leak Point Pressure (LPP) in children and adolescents 2-16 years of age with elevated detrusor LPP of neuropathic etiology and detrusor LPP ≥ 40 cm H2O.

Secondary objectives were:

* To investigate the safety and tolerability of two doses of Alfuzosin in comparison to Placebo in children and adolescents,
* To evaluate the effects of the two doses of Alfuzosin in comparison to Placebo on:

  * Detrusor compliance,
  * Urinary tract infection,
* To investigate the pharmacokinetics of Alfuzosin (population kinetics),
* To evaluate the 12-month long-term safety of Alfuzosin 0.1 mg/kg/day and 0.2 mg/kg/day.

The study consisted of 2 periods:

* a 12-week double blind treatment period where patients were to receive either Alfuzosin 0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day or placebo then,
* a 40-week open label extension treatment period where patients were to receive either Alfuzosin 0.1 mg/kg/day or Alfuzosin 0.2 mg/kg/day.

Detailed description:
Patients who met the study entry criteria were randomized (2:1:2:1) to one of the 4 dosage groups (Alfuzosin 0.1 mg/kg/day, matching placebo 0.1 mg/kg/day, Alfuzosin 0.2 mg/mg/kg, matching placebo 0.2 mg/kg/day).

Patients received their treatment using either solution or tablet formulation depending on age as follows:

* Solution to children 2-7 years of age or, children and adolescents 8-16 years of age if they were unable to swallow tablets or they preferred to take the solution or if they had a body weight \< 30kg. The daily dose was devided in 3 doses given at at breakfast, lunch and dinner.
* Tablet to children and adolescents 8-16 years of age who were able to swallow tablets and had a body weight ≥ 30kg. The daily dose was devided in 2 doses given at at breakfast and dinner.

Patients who have completed the 12-week double-blind phase were offered to continue in the 40-week open-label extension study.

* Patients receiving Alfuzosin continued with their dosing regimen.
* Patients receiving Placebo were switched to Alfuzosin with a dose corresponding to their randomization dose group.

All patients had a one-week follow-up period after last dose intake.

Arms:
arm 1: Matching placebo 0.1 mg/kg/day or 0.2 mg/kg/day arm 2: None arm 3: None

Interventions: intervention 1: Alfuzosin intervention 2: Placebo
Intervention descriptions: intervention 1: Form: solution or tablet according to age

Route: oral

Dose: daily dose adjusted to body weight intervention 2: Form: matching solution or matching tablet according to age

Route: oral

Dose: daily dose adjusted to body weight

Protocol document: