Primary objective was to determine efficacy of Alfuzosin in the treatment of children and adolescents 2-16 years of age with newly diagnosed or progressive hydronephrosis due to elevated detrusor Leak Point Pressure [LPP] of neuropathic etiology.

Secondary objectives were:

• To investigate the safety and tolerability of alfuzosin 0.2 mg/kg/day in children and adolescents,
• To investigate the number of Urinary Tract Infection (UTI) episodes,
• To investigate the pharmacokinetics of Alfuzosin (population kinetics).

The study consisted of 2 phases:

• a 12-week efficacy phase then,
• a 40-week safety extension phase.

All eligible subjects received alfuzosin 0.2 mg/kg/day. The formulation and the frequency was assigned by Interactive Voice Response System (IVRS) according to age group and ability to swallow tablets.

Patients who completed the 12-week open-label treatment period were offered to continue in the 40-week open-label safety extension study. The treatment was the same as in the 12-week efficacy phase.

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

Inclusion Criteria:

• Children and adolescents of either gender 2 - 16 years of age with a detrusor Leak Point Pressure (LPP) of 40 cm water or greater and with newly diagnosed or progressive hydronephrosis either Society of Fetal Urology (SFU) grade 1, 2 or 3 due to neuropathic bladder dysfunction.

Exclusion Criteria:

• Hydronephrosis of non-neuropathic etiology.
• Urological surgery in the last 4 months prior to the study.
• Urethral dilatation in the last 3 months prior to the baseline urodynamic assessment.
• α-blocker therapy in the last 4 weeks prior to the baseline urodynamic assessment.
• Detrusor injections of botulinum toxin in the last 6 months.
• Urological diseases/conditions other than functional bladder obstruction of neuropathic etiology, that can lead to upper urinary tract dilatation (e.g., bladder anomalies, ureterocele).
• History of intolerance to α-blocker therapy.
• Orthostatic hypotension.
• History of risk factors for Torsade de pointes (e.g., family history of Long QT Syndrome).

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

All Adverse Events (AE) regardless of seriousness or relationship to drug, spanning from signature of the informed consent form up to the last visit were collected.

The analysis was performed on the exposed population (i.e. all included patients exposed to Alfuzosin regardless of the amount of treatment administered) and included all AE that developed/worsened during the 'on treatment period' (i.e. from first dose up to 2 days after the last dose of Alfuzosin).

This was an exploratory, open-label, non-comparative trial. Analyses were purely descriptive.