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

Mansoura University

Status and phase: Enrolling; Phase 3

Conditions: Posterior Urethral Valve

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06737016

Tamsulosin & PUV

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: Male

Ages: Under 12 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Oxybutynin and Trimethoprim/sulphamethoxazole

Active Comparator group

Description:

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

Treatment:

Drug: Trimethoprim/sulfamethoxazole (TMP/SMZ)

Drug: Oxybutynin

Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole

Experimental group

Description:

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

Treatment:

Drug: Trimethoprim/sulfamethoxazole (TMP/SMZ)

Drug: Oxybutynin

Drug: Tamsulosin