Clinical trial NCT06737016: Efficacy and Safety of Tamsulosin for Children with Posterior Urethral Valve.
Official title: Efficacy and Safety of Tamsulosin, a Selective Alpha-1 Adrenergic Blocker, for Children with Posterior Urethral Valve: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Posterior Urethral Valve
Keywords: Posterior Urethral Valve
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2024-12-17
Enrollment: 50
Sex: MALE
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized controlled clinical trial
Primary purpose: TREATMENT

Brief summary: 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.

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

Eligibility 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

Primary outcomes:
measure: The effect of alpha adrenergic blocker, tamsulosin, on upper urinary tract in children with posterior urethral valves.
timeFrame: 1 year
measure: The safety of alpha adrenergic blocker, tamsulosin, in children with posterior urethral valves.
timeFrame: 1 year
Secondary outcomes:
measure: The effect of alpha adrenergic blocker, tamsulosin, on lower urinary tract in children with posterior urethral valves.
timeFrame: 1 year
measure: Febrile Urinary Tract Infections recurrence
timeFrame: 1 year
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura Urology and Nephrology Center
state: Dakahlia
Study officials:
affiliation: Urology and Nephrology center,Mansoura university
name: Ashraf Tarek Hafez
role: STUDY_CHAIR
affiliation: Urology and Nephrology center,Mansoura university
name: Tamer Helmy
role: STUDY_DIRECTOR
affiliation: Urology and Nephrology center,Mansoura university
name: Ahmed Elkashef
role: STUDY_DIRECTOR
affiliation: Urology and Nephrology center,Mansoura university
name: Mohamed Hussiny
role: PRINCIPAL_INVESTIGATOR
References:
citation: Austin PF, Homsy YL, Masel JL, Cain MP, Casale AJ, Rink RC. alpha-Adrenergic blockade in children with neuropathic and nonneuropathic voiding dysfunction. J Urol. 1999 Sep;162(3 Pt 2):1064-7. doi: 10.1016/S0022-5347(01)68067-4.
citation: Abraham MK, Nasir AR, Sudarsanan B, Puzhankara R, Kedari PM, Unnithan GR, Damisetti KR, Narayanan T. Role of alpha adrenergic blocker in the management of posterior urethral valves. Pediatr Surg Int. 2009 Dec;25(12):1113-5. doi: 10.1007/s00383-009-2469-9. Epub 2009 Sep 1.