Posterior Urethral Valve
Conditions
Keywords
Posterior Urethral Valve
Brief summary
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.
Detailed description
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
Interventions
DRUGTamsulosin
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).
DRUGOxybutynin
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.
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
A randomized controlled clinical trial
Eligibility
Sex/Gender
MALE
Age
No minimum to 12 Years
Healthy volunteers
No
Inclusion criteria
* Children with a diagnosis of PUV.
Exclusion criteria
1. Patients with other conditions that can potentially affect lower or upper urinary tract functions (e.g. spinal dysraphism, anorectal malformation and prune belly syndrome) 2. Patients who were treated with urinary diversion as vesicostomy or cutaneous ureterostomy. 3. Patients who had primary treatment of PUV ablation at other hospitals. 4. Contraindications to α blocker treatment. 5. Patients who refuse to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of alpha adrenergic blocker, tamsulosin, on upper urinary tract in children with posterior urethral valves. | 1 year | 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) |
| The safety of alpha adrenergic blocker, tamsulosin, in children with posterior urethral valves. | 1 year | Number of children with treatment related adverse effects. Potential side effects will be discussed after initiating therapy, including postural hypotension, dizziness, headache and rhinitis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The effect of alpha adrenergic blocker, tamsulosin, on lower urinary tract in children with posterior urethral valves. | 1 year | 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) |
| Febrile Urinary Tract Infections recurrence | 1 year | fever 38.5C or higher with a positive urinalysis and bacterial growth |
Countries
Egypt
Contacts
Primary ContactMohamed Hussiny
Outcome results
None listed