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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oxybutynin and Trimethoprim/sulphamethoxazole | Active Comparator | Patients will undergo maintenance therapy Anticholinergic, oxybutynin and Continous Antibiotic Prophylaxis,Trimethoprim/sulphamethoxazole daily |
|
| Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole | Experimental | Patients will undergo maintenance therapy Tamsulosin in addition to Anticholinergic, Oxybutynin and Continous Antibiotic Prophylaxis, Trimethoprim/sulfamethoxazole daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamsulosin | Drug | 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). |
|
| Measure | Description | Time Frame |
|---|---|---|
| The 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) | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
male
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Hussiny | Contact | +201064156383 | mohamedhussiny1@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Ashraf Tarek Hafez | urology and nephrology center mansoura university | Study Chair |
| Tamer Helmy | urology and nephrology center mansoura university | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mansoura Urology and Nephrology Center | Recruiting | Al Mansurah | Dakahlia Governorate | 35511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10458432 | Background | Austin PF, Homsy YL, Masel JL, Cain MP, Casale AJ, Rink RC. alpha-Adrenergic blockade in children with neuropathic and nonneuropathic voiding dysfunction. J Urol. 1999 Sep;162(3 Pt 2):1064-7. doi: 10.1016/S0022-5347(01)68067-4. | |
| 19727771 | Background | Abraham MK, Nasir AR, Sudarsanan B, Puzhankara R, Kedari PM, Unnithan GR, Damisetti KR, Narayanan T. Role of alpha adrenergic blocker in the management of posterior urethral valves. Pediatr Surg Int. 2009 Dec;25(12):1113-5. doi: 10.1007/s00383-009-2469-9. Epub 2009 Sep 1. |
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| ID | Term |
|---|---|
| D000077409 | Tamsulosin |
| C005419 | oxybutynin |
| D014295 | Trimethoprim |
| D013420 | Sulfamethoxazole |
| ID | Term |
|---|---|
| D000096926 | Benzenesulfonamides |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
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A randomized controlled clinical trial
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| Oxybutynin | Drug | Children will be maintained on an oral dose of Oxybutynin 0.2 mg/kg 2 times daily. |
|
| Trimethoprim/sulfamethoxazole (TMP/SMZ) | Drug | Children will be maintained on an oral prophylactic dose of Trimethoprim/sulfamethoxazole 2 mg/kg single dose at night. |
|
| Febrile Urinary Tract Infections recurrence | fever 38.5C or higher with a positive urinalysis and bacterial growth | 1 year |
| Ahmed Elkashef |
| urology and nephrology center mansoura university |
| Study Director |
| Mohamed Hussiny | urology and nephrology center mansoura university | Principal Investigator |
| D001555 |
| Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013424 | Sulfanilamides |
| D000814 | Aniline Compounds |
| D000588 | Amines |