NCT06737016|RecruitingPhase 3
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Sponsor study identifier
interventional
50
1 country
1
Study Start
November 1, 2024
Actual (reported)Primary Completion
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 1, 2024
Actual (reported)November 29, 2024
Actual (reported)December 17, 2024
Actual (reported)May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
The effect of alpha adrenergic blocker, tamsulosin, on lower urinary tract in children with posterior urethral valves.
1 year
Febrile Urinary Tract Infections recurrence
1 year
Patients will undergo maintenance therapy Anticholinergic, oxybutynin and Continous Antibiotic Prophylaxis,Trimethoprim/sulphamethoxazole daily
Patients will undergo maintenance therapy Tamsulosin in addition to Anticholinergic, Oxybutynin and Continous Antibiotic Prophylaxis, Trimethoprim/sulfamethoxazole daily
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.
These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.
Grouped treatment entry
Trimethoprim/sulfamethoxazole (TMP/SMZ)
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry recordMansoura Urology and Nephrology Center
Al Mansurah, Dakahlia Governorate, 35511, Egypt
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.
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.
Ashraf Tarek Hafez
urology and nephrology center mansoura university
Tamer Helmy
urology and nephrology center mansoura university
Ahmed Elkashef
urology and nephrology center mansoura university
Mohamed Hussiny
urology and nephrology center mansoura university
First Submitted
November 29, 2024
First Posted
December 17, 2024
Study Start
November 1, 2024
Actual (reported)Primary Completion
May 2026
Estimated (date passed)Peri-operative Tamsulosin and Impact on Voiding Trial After Same-day Urogynecology Surgery
Children will be maintained on an oral prophylactic dose of Trimethoprim/sulfamethoxazole 2 mg/kg single dose at night.
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
December 20, 2024
Record last verified: 2024-12
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Source: ClinicalTrials.gov.
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