alpha-Adrenergic blockade in children with neuropathic and nonneuropathic voiding dysfunction.
P F Austin, Y L Homsy, J L Masel...
https://pubmed.ncbi.nlm.nih.gov/10458432Actively Recruiting
Phase 3
Age: 0 - 12Years
MALE
ID06737016
Efficacy and Safety of Tamsulosin, a Selective Alpha-1 Adrenergic Blocker, for Children with Posterior Urethral Valve: a Randomized Controlled Trial
Led by Mansoura University · Updated on 2024-12-20
50
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the safety and effectiveness of the drug Tamsulosin, a selective alpha-1 adrenergic blocker, in children diagnosed with Posterior Urethral Valve (PUV) after valve ablation. It focuses on understanding how Tamsulosin affects the upper urinary tract, bladder outlet resistance, intravesical detrusor pressure, and the recurrence of febrile urinary tract infections in this population. Participants will be divided into two groups. One group will receive maintenance therapy with anticholinergic medication (Oxybutynin) and continuous antibiotic prophylaxis (Trimethoprim/sulfamethoxazole). The other group will receive the same maintenance therapy plus Tamsulosin, dosed orally once daily at 0.1 mg for children under 2 years and 0.2 mg for children 2 years and older. Both groups will be monitored and compared over a one-year period. Throughout the study, children will undergo evaluations to monitor their upper and lower urinary tract health, including assessments of hydronephrosis improvement, vesicoureteric reflux resolution, renal function, bladder outlet resistance, and detrusor pressure. Researchers will also track the recurrence of febrile urinary tract infections and observe any side effects related to Tamsulosin. The study will last for one year with continuous safety monitoring to assess the drug's impact.
CONDITIONS
Brief Title
Efficacy and Safety of Tamsulosin for Children with Posterior Urethral Valve.
Who Can Participate
Age: 0 - 12Years
MALE
Eligibility Criteria
You may qualify if you...
- Children with a diagnosis of Posterior Urethral Valve
- Male gender
- Age 12 years or younger
You will not qualify if you...
- Patients with other conditions affecting urinary tract function such as spinal dysraphism, anorectal malformation, or prune belly syndrome
- Patients who have had urinary diversion surgery like vesicostomy or cutaneous ureterostomy
- Patients who received primary PUV ablation treatment at other hospitals
- Contraindications to alpha blocker treatment
- Patients who refuse to participate in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 1 year
Participants receive daily oral medication with Tamsulosin, Oxybutynin, and Trimethoprim/sulfamethoxazole or Oxybutynin and Trimethoprim/sulfamethoxazole alone to evaluate effects on urinary tract function and infection recurrence.
Regular visits during the 1-year treatment period
Trial Site Locations
Total: 1 location
1
Mansoura Urology and Nephrology Center
Al Mansurah, Dakahlia Governorate, Egypt, 35511
Actively Recruiting
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Research Team
M
Mohamed Hussiny
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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Published Research Related To This Trial
Role of alpha adrenergic blocker in the management of posterior urethral valves.
Mohan K Abraham, Abdul Rasheed A Nasir, Bindu Sudarsanan...
https://pubmed.ncbi.nlm.nih.gov/19727771