Efficacy and Safety of Tamsulosin for Children with Posterior Urethral Valve.

NCT06737016 | Recruiting Phase 3

• 1 other identifier: Tamsulosin & PUV
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Posterior Urethral Valve

Keywords

Posterior Urethral Valve

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• 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

Study Arms (2)

Oxybutynin and Trimethoprim/sulphamethoxazole

ACTIVE COMPARATOR

Patients will undergo maintenance therapy Anticholinergic, oxybutynin and Continous Antibiotic Prophylaxis,Trimethoprim/sulphamethoxazole daily

Drug: Oxybutynin; Drug: Trimethoprim/sulfamethoxazole (TMP/SMZ)

Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole

EXPERIMENTAL

Patients will undergo maintenance therapy Tamsulosin in addition to Anticholinergic, Oxybutynin and Continous Antibiotic Prophylaxis, Trimethoprim/sulfamethoxazole daily

Drug: Tamsulosin; Drug: Oxybutynin; Drug: Trimethoprim/sulfamethoxazole (TMP/SMZ)

Interventions

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).

Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole

Oxybutynin DRUG

Children will be maintained on an oral dose of Oxybutynin 0.2 mg/kg 2 times daily.

Oxybutynin and Trimethoprim/sulphamethoxazole; Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole

Trimethoprim/sulfamethoxazole (TMP/SMZ) DRUG

Children will be maintained on an oral prophylactic dose of Trimethoprim/sulfamethoxazole 2 mg/kg single dose at night.

Oxybutynin and Trimethoprim/sulphamethoxazole; Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole

Eligibility Criteria

• Age: Up to 12 Years
• Gender Eligibility Details: male
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Children with a diagnosis of PUV.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura Urology and Nephrology Center

Al Mansurah, Dakahlia Governorate, 35511, Egypt

RECRUITING

Related Publications (2)

• 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 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.

  PMID: 19727771 BACKGROUND

MeSH Terms

Interventions

Tamsulosin; oxybutynin; Trimethoprim; Sulfamethoxazole

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Sulfanilamides; Aniline Compounds; Amines

Study Officials

• Ashraf Tarek Hafez

  Urology and Nephrology center,Mansoura university

  STUDY CHAIR

• Tamer Helmy

  Urology and Nephrology center,Mansoura university

  STUDY DIRECTOR

• Ahmed Elkashef

  Urology and Nephrology center,Mansoura university

  STUDY DIRECTOR

• Mohamed Hussiny

  Urology and Nephrology center,Mansoura university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed Hussiny

CONTACT

+201064156383; mohamedhussiny1@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: A randomized controlled clinical trial

Study Record Dates

• First Submitted: November 29, 2024
• First Posted: December 17, 2024
• Study Start: November 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): November 1, 2026
• Last Updated: December 20, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)