Posterior Urethral ValvePhase 3NCT06737016
Efficacy and Safety of Tamsulosin for Children with Posterior Urethral Valve.
A Phase 3 study testing Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole (TMP/SMZ) in people with Posterior Urethral Valve, run by Mansoura University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 years, men only
- Conditions the study is for
- Posterior Urethral Valve
- What is being tested?
- Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole (TMP/SMZ)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2024to Nov 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Children with a diagnosis of PUV.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura Urology and Nephrology Center
Al Mansurah, Dakahlia Governorate, 35511
Mohamed Hussiny, +201064156383, mohamedhussiny1@yahoo.com
About this study
Official title: 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.
Read the 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
- Conditions
- Posterior Urethral Valve
- Being tested
- Tamsulosin, Oxybutynin, Trimethoprim/sulfamethoxazole (TMP/SMZ)
- Keywords
- Posterior Urethral Valve
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TamsulosinDrug
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).
OxybutyninDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Oxybutynin and Trimethoprim/sulphamethoxazole | Active comparator | Patients will undergo maintenance therapy Anticholinergic, oxybutynin and Continous Antibiotic Prophylaxis,Trimethoprim/sulphamethoxazole daily Receives: Drug: Oxybutynin; Drug: Trimethoprim/sulfamethoxazole (TMP/SMZ) |
| Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole | Experimental | Patients will undergo maintenance therapy Tamsulosin in addition to Anticholinergic, Oxybutynin and Continous Antibiotic Prophylaxis, Trimethoprim/sulfamethoxazole daily Receives: Drug: Tamsulosin; Drug: Oxybutynin; Drug: Trimethoprim/sulfamethoxazole (TMP/SMZ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of alpha adrenergic blocker, tamsulosin, on upper urinary tract in children with posterior urethral valves.
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)
Measured: 1 year
The safety of alpha adrenergic blocker, tamsulosin, in children with posterior urethral valves.
Number of children with treatment related adverse effects. Potential side effects will be discussed after initiating therapy, including postural hypotension, dizziness, headache and rhinitis.
Measured: 1 year
Secondary outcomes (2)
The effect of alpha adrenergic blocker, tamsulosin, on lower urinary tract in children with posterior urethral valves.
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)
Measured: 1 year
Febrile Urinary Tract Infections recurrence
fever 38.5C or higher with a positive urinalysis and bacterial growth
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2024
- Study start1 Nov 2024
- Primary completionMay 2026 (estimated)
- Study completionNov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Posterior Urethral ValveStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled clinical trial
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashraf Tarek Hafez, Study chair, urology and nephrology center mansoura universityTamer Helmy, Study director, urology and nephrology center mansoura universityAhmed Elkashef, Study director, urology and nephrology center mansoura universityMohamed Hussiny, Principal investigator, urology and nephrology center mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06737016
- Sponsor's protocol ID
- Tamsulosin & PUV
- Status last verified
- Dec 2024
- First submitted
- 29 Nov 2024
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 10458432Abraham 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.
PubMed 19727771
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Tamsulosin, a Selective Alpha-1 Adrenergic Blocker, for Children with Posterior Urethral Valve: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06737016
- Acronym / sponsor ID
- Tamsulosin & PUV
- Conditions
- Posterior Urethral Valve
- Keywords
- Posterior Urethral Valve
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- Nov 2026 (estimated)
- First posted
- 17 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized controlled clinical trial
| Arm | Type | Receives |
|---|---|---|
| Oxybutynin and Trimethoprim/sulphamethoxazole | Active comparator | Drug: Oxybutynin, Drug: Trimethoprim/sulfamethoxazole (TMP/SMZ)Patients will undergo maintenance therapy Anticholinergic, oxybutynin and Continous Antibiotic Prophylaxis,Trimethoprim/sulphamethoxazole daily |
| Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole | Experimental | Drug: Tamsulosin, Drug: Oxybutynin, Drug: Trimethoprim/sulfamethoxazole (TMP/SMZ)Patients will undergo maintenance therapy Tamsulosin in addition to Anticholinergic, Oxybutynin and Continous Antibiotic Prophylaxis, Trimethoprim/sulfamethoxazole daily |
Who may qualify
- Ages
- Up to 12 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Children with a diagnosis of PUV.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TamsulosinChildren 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). | Drug | Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole |
| OxybutyninChildren will be maintained on an oral dose of Oxybutynin 0.2 mg/kg 2 times daily. | Drug | Oxybutynin and Trimethoprim/sulphamethoxazole, Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole |
| Trimethoprim/sulfamethoxazole (TMP/SMZ)Children will be maintained on an oral prophylactic dose of Trimethoprim/sulfamethoxazole 2 mg/kg single dose at night. | Drug | Oxybutynin and Trimethoprim/sulphamethoxazole, Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole |
Primary outcome
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)
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.
2 secondary outcomes
The effect of alpha adrenergic blocker, tamsulosin, on lower urinary tract in children with posterior urethral valves.
Time frame: 1 year
Febrile Urinary Tract Infections recurrence
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2024.
- Background: PubMed 10458432Austin 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.
- Background: PubMed 19727771Abraham 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.
- Individual participant dataSharing planned: No
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Posterior Urethral Valves
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ashraf Tarek Hafez study chair
urology and nephrology center mansoura university
Tamer Helmy study director
urology and nephrology center mansoura university
Ahmed Elkashef study director
urology and nephrology center mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tamsulosin, Oxybutynin and Trimethoprim/sulfamethoxazole (TMP/SMZ) in people with Posterior Urethral Valve, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mohamed Hussiny (+201064156383, mohamedhussiny1@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The effect of alpha adrenergic blocker, tamsulosin, on upper urinary tract in children with posterior urethral valves. (time frame: 1 year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06737016, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2024.