Alfuzosin Treatment in Children and Adolescents With Hydronephrosis of Neuropathic Etiology (Alfahydro)
Hydronephrosis, Neurogenic Bladder
About this trial
This is an interventional treatment trial for Hydronephrosis focused on measuring child, bladder, neuropathic, alpha blockers
Eligibility Criteria
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.
Sites / Locations
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Aministrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
- Sanofi-Aventis Administrative Office
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
Alfuzosin solution - 2-7 years
Alfuzosin solution - 8-16 years
Alfuzosin tablet - 8-16 years
Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children 2-7 years of age.
Alfuzosin solution, daily dose divided in 3 doses given at breakfast, lunch and dinner to children and adolescents 8-16 years of age who were not able to swallow tablets or preferred to take the solution or had a body weight < 30 kg.
Alfuzosin tablet, daily dose divided in 2 doses given at breakfast and dinner to children and adolescents 8-16 years of age who were able to swallow tablets and had a body weight ≥ 30 kg.