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

Phase 3

Recruiting

• Conditions: Posterior Urethral Valve
• Interventions: Drug: Oxybutynin; Drug: Tamsulosin; Drug: Trimethoprim/sulfamethoxazole (TMP/SMZ)

• Registration Number: NCT06737016
• Lead Sponsor: Mansoura University

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.

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

Study Timeline

• Study Start: 2024-11-01
• Study First Submitted: 2024-11-29
• Status Verified: 2024-12
• Study First Submitted QC: 2024-12-14
• Study First Posted: 2024-12-17
• Last Update Submitted: 2024-12-19
• Last Update Posted: 2024-12-20
• Primary Completion: 2026-05
• Study Completion: 2026-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 50

Inclusion Criteria

• Children with a diagnosis of PUV.

Exclusion Criteria

1. Patients with other conditions that can potentially affect lower or upper urinary tract functions (e.g. spinal dysraphism, anorectal malformation and prune belly syndrome)
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxybutynin and Trimethoprim/sulphamethoxazole	Oxybutynin	Patients will undergo maintenance therapy Anticholinergic, oxybutynin and Continous Antibiotic Prophylaxis,Trimethoprim/sulphamethoxazole daily
Oxybutynin and Trimethoprim/sulphamethoxazole	Trimethoprim/sulfamethoxazole (TMP/SMZ)	Patients will undergo maintenance therapy Anticholinergic, oxybutynin and Continous Antibiotic Prophylaxis,Trimethoprim/sulphamethoxazole daily
Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole	Tamsulosin	Patients will undergo maintenance therapy Tamsulosin in addition to Anticholinergic, Oxybutynin and Continous Antibiotic Prophylaxis, Trimethoprim/sulfamethoxazole daily
Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole	Oxybutynin	Patients will undergo maintenance therapy Tamsulosin in addition to Anticholinergic, Oxybutynin and Continous Antibiotic Prophylaxis, Trimethoprim/sulfamethoxazole daily
Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole	Trimethoprim/sulfamethoxazole (TMP/SMZ)	Patients will undergo maintenance therapy Tamsulosin in addition to Anticholinergic, Oxybutynin and Continous Antibiotic Prophylaxis, Trimethoprim/sulfamethoxazole daily

Primary Outcome Measures

Name	Time	Method
The effect of alpha adrenergic blocker, tamsulosin, on upper urinary tract in children with posterior urethral valves.	1 year	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)
The safety of alpha adrenergic blocker, tamsulosin, in children with posterior urethral valves.	1 year	Number of children with treatment related adverse effects. Potential side effects will be discussed after initiating therapy, including postural hypotension, dizziness, headache and rhinitis.

Secondary Outcome Measures

Name	Time	Method
The effect of alpha adrenergic blocker, tamsulosin, on lower urinary tract in children with posterior urethral valves.	1 year	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)
Febrile Urinary Tract Infections recurrence	1 year	fever 38.5C or higher with a positive urinalysis and bacterial growth

Trial Locations

Locations (1)

Mansoura Urology and Nephrology Center; 🇪🇬 Mansoura, Dakahlia, Egypt