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

December 19, 2024 updated by: Mansoura University

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Egypt
    • Dakahlia
      • Mansoura, Dakahlia, Egypt, 35511
        • Recruiting
        • Mansoura Urology and Nephrology Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Oxybutynin and Trimethoprim/sulphamethoxazole
Patients will undergo maintenance therapy Anticholinergic, oxybutynin and Continous Antibiotic Prophylaxis,Trimethoprim/sulphamethoxazole daily
Drug: Oxybutynin
Children will be maintained on an oral dose of Oxybutynin 0.2 mg/kg 2 times daily.
Drug: Trimethoprim/sulfamethoxazole (TMP/SMZ)
Children will be maintained on an oral prophylactic dose of Trimethoprim/sulfamethoxazole 2 mg/kg single dose at night.
Experimental: Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole
Patients will undergo maintenance therapy Tamsulosin in addition to Anticholinergic, Oxybutynin and Continous Antibiotic Prophylaxis, Trimethoprim/sulfamethoxazole daily
Drug: Oxybutynin
Children will be maintained on an oral dose of Oxybutynin 0.2 mg/kg 2 times daily.
Drug: Trimethoprim/sulfamethoxazole (TMP/SMZ)
Children will be maintained on an oral prophylactic dose of Trimethoprim/sulfamethoxazole 2 mg/kg single dose at night.
Drug: Tamsulosin
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 year
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.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
1 year
Febrile Urinary Tract Infections recurrence
Time Frame: 1 year
fever 38.5C or higher with a positive urinalysis and bacterial growth
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mansoura University

Investigators

  • Study Chair: Ashraf Tarek Hafez, Urology and Nephrology center,Mansoura university
  • Study Director: Tamer Helmy, Urology and Nephrology center,Mansoura university
  • Study Director: Ahmed Elkashef, Urology and Nephrology center,Mansoura university
  • Principal Investigator: Mohamed Hussiny, Urology and Nephrology center,Mansoura university

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2024

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

November 1, 2026

Study Registration Dates

First Submitted

November 29, 2024

First Submitted That Met QC Criteria

December 14, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 19, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Tamsulosin & PUV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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