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

ConditionPosterior Urethral Valve
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexMale
AgeUp to 12
SponsorMansoura University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Children with a diagnosis of PUV.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • Oxybutynin

    Drug

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

  • Trimethoprim/sulfamethoxazole (TMP/SMZ)

    Drug

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Oxybutynin and Trimethoprim/sulphamethoxazoleActive comparator 2 interventions
Group B: Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazoleExperimental treatment 3 interventions

Trial outcomes

Primary outcomes

1

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)

Time frame
1 year
2

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.

Time frame
1 year

Secondary outcomes

1

The effect of alpha adrenergic blocker, tamsulosin, on lower urinary tract in children with posterior urethral valves.

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)

Time frame
1 year
2

Febrile Urinary Tract Infections recurrence

fever 38.5C or higher with a positive urinalysis and bacterial growth

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mansoura University

Lead sponsor

Source ClinicalTrials.gov
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