Efficacy and Safety of Tamsulosin for Children with Posterior Urethral Valve.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Tamsulosin, Oxybutynin, Trimethoprim/sulfamethoxazole (TMP/SMZ).
- Who it may be relevant to
- Registry conditions: Posterior Urethral Valve. Basic parameters: up to 12 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Tamsulosin, a Selective Alpha-1 Adrenergic Blocker, for Children with Posterior Urethral Valve: a Randomized Controlled Trial
Overview
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
- Drug Tamsulosin
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). - Drug Oxybutynin
Children will be maintained on an oral dose of Oxybutynin 0.2 mg/kg 2 times daily. - Drug Trimethoprim/sulfamethoxazole (TMP/SMZ)
Children will be maintained on an oral prophylactic dose of Trimethoprim/sulfamethoxazole 2 mg/kg single dose at night.
Primary outcome measures
- The effect of alpha adrenergic blocker, tamsulosin, on upper urinary tract in children with posterior urethral valves. [Time frame: 1 year]
- The safety of alpha adrenergic blocker, tamsulosin, in children with posterior urethral valves. [Time frame: 1 year]
Secondary outcome measures (2)
- The effect of alpha adrenergic blocker, tamsulosin, on lower urinary tract in children with posterior urethral valves. [Time frame: 1 year]
- Febrile Urinary Tract Infections recurrence [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- Children with a diagnosis of PUV.
Exclusion criteria
- Patients with other conditions that can potentially affect lower or upper urinary tract functions (e.g. spinal dysraphism, anorectal malformation and prune belly syndrome)
- Patients who were treated with urinary diversion as vesicostomy or cutaneous ureterostomy.
- Patients who had primary treatment of PUV ablation at other hospitals.
- Contraindications to α blocker treatment.
- Patients who refuse to participate in the study
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Mansoura Urology and Nephrology Center — Al Mansurah
Publications
- 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. PMID 10458432
- 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. PMID 19727771
Identifiers
NCT: NCT06737016 · Tamsulosin & PUV