To determine whether there is a role for Tamsulosin, A Selective Alpha-1 Adrenergic Blocker, as therapy in children with Posterior Urethral Valve post valve ablation , and whether there are side effects involved.
We aim to evaluate the safety and efficacy of alpha adrenergic blocker, tamsulosin, in children with posterior urethral valves regarding: * Effect on upper urinary tract (Hydronephrosis improvement, Vesicoureteric Reflux resolution and renal function) * Effect on bladder outlet resistance * Effect on intravesical detrusor pressure * Febrile Urinary Tract Infection recurrence
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Children will be maintained on an oral dose of Tamsulosin 0.1 mg once daily (in children aged less than 2 years old) and 0.2 mg once daily (≥2 years old).
Children will be maintained on an oral dose of Oxybutynin 0.2 mg/kg 2 times daily.
Children will be maintained on an oral prophylactic dose of Trimethoprim/sulfamethoxazole 2 mg/kg single dose at night.
Mansoura Urology and Nephrology Center
Al Mansurah, Dakahlia Governorate, Egypt
RECRUITINGThe effect of alpha adrenergic blocker, tamsulosin, on upper urinary tract in children with posterior urethral valves.
The effect of alpha adrenergic blocker, tamsulosin, on upper urinary tract in children with posterior urethral valves. This will be assessed by: \- Change in Hydronephrosis grading (resolution of low grade (I or II) Hydronephrosis or downgrading of high grade (III or IV) Hydronephrosis to grade II or less)
Time frame: 1 year
The safety of alpha adrenergic blocker, tamsulosin, in children with posterior urethral valves.
Number of children with treatment related adverse effects. Potential side effects will be discussed after initiating therapy, including postural hypotension, dizziness, headache and rhinitis.
Time frame: 1 year
The effect of alpha adrenergic blocker, tamsulosin, on lower urinary tract in children with posterior urethral valves.
The effect of alpha adrenergic blocker, tamsulosin, on lower urinary tract in children with posterior urethral valves. This will be assessed by: • Change in Bladder neck Hypertrophy ( as determined by Voiding Cysto-Urethrogram imaging)
Time frame: 1 year
Febrile Urinary Tract Infections recurrence
fever 38.5C or higher with a positive urinalysis and bacterial growth
Time frame: 1 year
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