Using Tamsulosin to treat children with Posterior Urethral Valve
Efficacy and Safety of Tamsulosin, a Selective Alpha-1 Adrenergic Blocker, for Children with Posterior Urethral Valve: a Randomized Controlled Trial
This study is testing if the medication Tamsulosin can help children with Posterior Urethral Valve feel better and reduce urinary problems after their treatment.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | N/A to 12 Years |
| Sex | Male |
| Sponsor | Mansoura University Academic / other |
| Locations | 1 site (Al Mansurah, Dakahlia Governorate) |
| Trial ID | NCT06737016 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of Tamsulosin, an alpha-1 adrenergic blocker, in children diagnosed with Posterior Urethral Valve (PUV) following valve ablation. The research focuses on assessing improvements in upper urinary tract conditions, bladder outlet resistance, and the recurrence of urinary tract infections. Participants will receive Tamsulosin along with other medications like Oxybutynin and Trimethoprim/sulfamethoxazole to monitor their effects. The study aims to provide insights into the potential benefits and side effects of this treatment approach.
Who should consider this trial
Good fit: Ideal candidates for this study are children diagnosed with Posterior Urethral Valve.
Not a fit: Patients with other urinary tract conditions or those who have undergone urinary diversion procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve urinary function and reduce complications in children with Posterior Urethral Valve.
How similar studies have performed: While the use of Tamsulosin in adults has shown promise, this specific application in children with PUV is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Al Mansurah, Dakahlia Governorate
- Mansoura Urology and Nephrology Center — Al Mansurah, Dakahlia Governorate, Egypt (Recruiting)
Study contacts
- Principal investigator: Mohamed Hussiny — urology and nephrology center mansoura university
- Study coordinator: Mohamed Hussiny
- Email: mohamedhussiny1@yahoo.com
- Phone: +201064156383
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.