Alfuzosin Treatment in Children and Adolescents With Neurogenic Urinary Bladder Dysfunction
Condition: Neurogenic Urinary Bladder
MeSH terms: Urinary Bladder, Neurogenic
Intervention: Alfuzosin; Placebo
Intervention description: Form: solution or tablet according to age
Route: oral
Dose: daily dose adjusted to body weight; Form: matching solution or matching tablet according to age
Route: oral
Dose: daily dose adjusted to body weight
Intervention MeSH terms: Alfuzosin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 172.0
Sex: All
Minimum age: 2 Years
Maximum age: 16 Years
Healthy volunteers: No
Keywords: child; bladder; neuropathic; alpha blockers

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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patient with elevated detrusor Leak Point Pressure (LPP) of neuropathic etiology and
             Detrusor LPP ≥ 40 cm H2O and < 100 cm H2O.

        Exclusion Criteria:

          -  Urological surgery in the last 4 months prior to the study,

          -  Patients who have 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.