Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06737016

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

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Posterior Urethral Valve

Age range

Up to 12 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 3

Primary location

Mansoura Urology and Nephrology Center

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location status: Recruiting

Location contact

Mohamed Hussiny

CONTACT

[email protected]

+201064156383

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children with a diagnosis of PUV.

Exclusion criteria

  • 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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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)

  2. The safety of alpha adrenergic blocker, tamsulosin, in children with posterior urethral valves.

    Time frame: 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 outcomes

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

    Time frame: 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)

  2. Febrile Urinary Tract Infections recurrence

    Time frame: 1 year

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

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed Hussiny

CONTACT

[email protected]

+201064156383

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Efficacy and Safety of Tamsulosin, a Selective Alpha-1 Adrenergic Blocker, for Children with Posterior Urethral Valve: a Randomized Controlled Trial

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Dec 17, 2024
Registry last updated
Dec 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.