Efficacy and Safety of Tamsulosin for Children with Posterior Urethral Valve.
NCT ID: NCT06737016
Last Updated: 2024-12-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
50 participants
INTERVENTIONAL
2024-11-01
2026-11-30
Brief Summary
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Detailed Description
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* 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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oxybutynin and Trimethoprim/sulphamethoxazole
Patients will undergo maintenance therapy Anticholinergic, oxybutynin and Continous Antibiotic Prophylaxis,Trimethoprim/sulphamethoxazole daily
Oxybutynin
Children will be maintained on an oral dose of Oxybutynin 0.2 mg/kg 2 times daily.
Trimethoprim/sulfamethoxazole (TMP/SMZ)
Children will be maintained on an oral prophylactic dose of Trimethoprim/sulfamethoxazole 2 mg/kg single dose at night.
Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole
Patients will undergo maintenance therapy Tamsulosin in addition to Anticholinergic, Oxybutynin and Continous Antibiotic Prophylaxis, Trimethoprim/sulfamethoxazole daily
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).
Oxybutynin
Children will be maintained on an oral dose of Oxybutynin 0.2 mg/kg 2 times daily.
Trimethoprim/sulfamethoxazole (TMP/SMZ)
Children will be maintained on an oral prophylactic dose of Trimethoprim/sulfamethoxazole 2 mg/kg single dose at night.
Interventions
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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).
Oxybutynin
Children will be maintained on an oral dose of Oxybutynin 0.2 mg/kg 2 times daily.
Trimethoprim/sulfamethoxazole (TMP/SMZ)
Children will be maintained on an oral prophylactic dose of Trimethoprim/sulfamethoxazole 2 mg/kg single dose at night.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
12 Years
MALE
No
Sponsors
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Mansoura University
OTHER
Responsible Party
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Principal Investigators
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Ashraf Tarek Hafez
Role: STUDY_CHAIR
Urology and Nephrology center,Mansoura university
Tamer Helmy
Role: STUDY_DIRECTOR
Urology and Nephrology center,Mansoura university
Ahmed Elkashef
Role: STUDY_DIRECTOR
Urology and Nephrology center,Mansoura university
Mohamed Hussiny
Role: PRINCIPAL_INVESTIGATOR
Urology and Nephrology center,Mansoura university
Locations
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Mansoura Urology and Nephrology Center
Al Mansurah, Dakahlia Governorate, Egypt
Countries
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Central Contacts
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Facility Contacts
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Mohamed Hussiny
Role: primary
References
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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.
Other Identifiers
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Tamsulosin & PUV
Identifier Type: -
Identifier Source: org_study_id