HypospadiasNCT07421271
Evaluation of the Method and Duration of Urinary Diversion in the Management of Distal Penile Hypospadias Following Surgical Repair.
A study testing Application of urethral catheter alone for 1 week., Application of urethral catheter alone for 2 weeks. and Application of urethral stent and suprapubic catheter for 1 week in people with Hypospadias and Urinary Diversion, run by Ain Shams University at 1 site in Egypt.
Trial summary
This study aims to conduct a head-to-head comparison to determine the optimal method and duration of urinary diversion following distal penile hypospadias repair. Specifically, it will evaluate whether urethral diversion alone or a combination of urethral and suprapubic diversions provides better outcomes, and whether… Read more about this study
- Who is it for?
- Ages 6 months to 18 years, men only
- Conditions the study is for
- Hypospadias, Urinary Diversion
- What is being tested?
- Application of urethral catheter alone for 1 week., Application of urethral catheter alone for 2 weeks. and Application of urethral stent and suprapubic catheter for 1 week
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Apr 2025to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 6 months to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with Distal Hypospadias (Glanular, Coronal, Subcoronal)
- Patients have Adequate ventral penile skin mobility
Who cannot join
- Patients with Crippled hypospadias.
- Patients with Proximal hypospadias.
- Patients with Hypoplastic urethra.
- Patients with Neurogenic bladder
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to conduct a head-to-head comparison to determine the optimal method and duration of urinary diversion following distal penile hypospadias repair. Specifically, it will evaluate whether urethral diversion alone or a combination of urethral and suprapubic diversions provides better outcomes, and whether a postoperative duration of one week or two weeks is more effective.
- Conditions
- Hypospadias, Urinary Diversion
- Being tested
- Application of urethral catheter alone for 1 week., Application of urethral catheter alone for 2 weeks., Application of urethral stent and suprapubic catheter for 1 week, Application of urethral stent and suprapubic catheter for 2 weeks
- Medical subject headings
- Hypospadias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of urethral catheter alone for 1 week.Procedure or surgery
Application of urethral catheter alone for 1 week.
Application of urethral catheter alone for 2 weeks.Procedure or surgery
Application of urethral catheter alone for 2 weeks.
Application of urethral stent and suprapubic catheter for 1 weekProcedure or surgery
Application of urethral stent and suprapubic catheter for 1 week
Application of urethral stent and suprapubic catheter for 2 weeksProcedure or surgery
Application of urethral stent and suprapubic catheter for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Patients who will be left with urethral catheter alone for 1 week. | Active comparator | Not described Receives: Procedure: Application of urethral catheter alone for 1 week. |
| Patient who will be left with urethral catheter for 2 weeks. | Active comparator | Not described Receives: Procedure: Application of urethral catheter alone for 2 weeks. |
| Patients who will be left with urethral stent and suprapubic catheter for 1 week | Active comparator | Not described Receives: Procedure: Application of urethral stent and suprapubic catheter for 1 week |
| Patients who will be left with urethral stent and suprapubic catheter for 2 weeks | Active comparator | Not described Receives: Procedure: Application of urethral stent and suprapubic catheter for 2 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decreased rate of fistula occurrence
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2026
- Study start10 Apr 2025
- Primary completion15 Oct 2025
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by Ain Shams 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07421271
- Sponsor's protocol ID
- Hypospadias diversion
- Status last verified
- Feb 2026
- First submitted
- 12 Feb 2026
- Last updated
- 19 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
1. McDougal, W. S., Wein, A. J., Kavoussi, L. R., Partin, A. W., & Peters, C. A. (2015). Campbell-Walsh urology 11th Edition review e-book. Elsevier Health Sciences..
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Method and Duration of Urinary Diversion in the Management of Distal Penile Hypospadias Following Surgical Repair.
- ClinicalTrials.gov ID
- NCT07421271
- Acronym / sponsor ID
- Hypospadias diversion
- Conditions
- Hypospadias, Urinary Diversion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 10 Apr 2025 (actual)
- Primary completion
- 15 Oct 2025 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 19 Feb 2026 (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.
This study aims to conduct a head-to-head comparison to determine the optimal method and duration of urinary diversion following distal penile hypospadias repair. Specifically, it will evaluate whether urethral diversion alone or a combination of urethral and suprapubic diversions provides better outcomes, and whether a postoperative duration of one week or two weeks is more effective.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Patients who will be left with urethral catheter alone for 1 week. | Active comparator | Procedure: Application of urethral catheter alone for 1 week. |
| Patient who will be left with urethral catheter for 2 weeks. | Active comparator | Procedure: Application of urethral catheter alone for 2 weeks. |
| Patients who will be left with urethral stent and suprapubic catheter for 1 week | Active comparator | Procedure: Application of urethral stent and suprapubic catheter for 1 week |
| Patients who will be left with urethral stent and suprapubic catheter for 2 weeks | Active comparator | Procedure: Application of urethral stent and suprapubic catheter for 2 weeks |
Who may qualify
- Ages
- 6 months to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Patients with Distal Hypospadias (Glanular, Coronal, Subcoronal)
- Patients have Adequate ventral penile skin mobility
Key exclusion criteria (4 listed)
- Patients with Crippled hypospadias.
- Patients with Proximal hypospadias.
- Patients with Hypoplastic urethra.
- Patients with Neurogenic bladder
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 |
|---|---|---|
| Application of urethral catheter alone for 1 week.Application of urethral catheter alone for 1 week. | Procedure or surgery | Patients who will be left with urethral catheter alone for 1 week. |
| Application of urethral catheter alone for 2 weeks.Application of urethral catheter alone for 2 weeks. | Procedure or surgery | Patient who will be left with urethral catheter for 2 weeks. |
| Application of urethral stent and suprapubic catheter for 1 weekApplication of urethral stent and suprapubic catheter for 1 week | Procedure or surgery | Patients who will be left with urethral stent and suprapubic catheter for 1 week |
| Application of urethral stent and suprapubic catheter for 2 weeksApplication of urethral stent and suprapubic catheter for 2 weeks | Procedure or surgery | Patients who will be left with urethral stent and suprapubic catheter for 2 weeks |
Primary outcome
Decreased rate of fistula occurrence
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2026.
- Results publication1. McDougal, W. S., Wein, A. J., Kavoussi, L. R., Partin, A. W., & Peters, C. A. (2015). Campbell-Walsh urology 11th Edition review e-book. Elsevier Health Sciences..
- Individual participant dataSharing planned: Yes
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of urethral catheter alone for 1 week., Application of urethral catheter alone for 2 weeks. and Application of urethral stent and suprapubic catheter for 1 week in people with Hypospadias and Urinary Diversion, run by Ain Shams 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 2 inclusion and 4 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: finished, as of the sponsor's last update on 19 Feb 2026. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Decreased rate of fistula occurrence (time frame: 1 month). 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 NCT07421271, which also lists 1 linked publication.
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 19 Feb 2026.