HypospadiasNCT05960123
Evaluation of TIP Urethroplasty With Spongioplasty-Dartosoraphy Reinforcement in Pediatric Hypospadias
A study testing Tubularized Incised Plate (TIP) urethroplasty in people with Hypospadias and Complication,Postoperative, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The study aimed to evaluation of Tubularized incised palate urethroplasty with spongioplasty-dartosoraphy reinforcement (group A) through comparing of functional and cosmetic results of this technique with the conventional TIP urethroplasty (group B). Read more about this study
- Who is it for?
- Ages 6 months to 14 years, men only
- Conditions the study is for
- Hypospadias, Complication,Postoperative
- What is being tested?
- Tubularized Incised Plate (TIP) urethroplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 30 May 2023
- 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 14 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- lees than 14 years Distal hypospadias urethral plate size more than 6mm glans size more than 14 mm
Who cannot join
- recurrent cases Proximal; hypospadias
Trial locations and contacts
1 site in 1 country.
About this study
The study aimed to evaluation of Tubularized incised palate urethroplasty with spongioplasty-dartosoraphy reinforcement (group A) through comparing of functional and cosmetic results of this technique with the conventional TIP urethroplasty (group B).
- Conditions
- Hypospadias, Complication,Postoperative
- Being tested
- Tubularized Incised Plate (TIP) urethroplasty
- Keywords
- Distal and midpenile hypospadias, TIPU, Spongioplasty-dartosoraphy, pediatric HOSE
- Medical subject headings
- Hypospadias, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tubularized Incised Plate (TIP) urethroplastyProcedure or surgery
tubularization of urethral plate with or without spongioplasty
| Study group | Role | What they receive |
|---|---|---|
| Group with Spongioplasty | Active comparator | patients underwent TIPU with spongioplasty-Dartosoraphy reinforcement Receives: Procedure: Tubularized Incised Plate (TIP) urethroplasty |
| Group without Spongioplasty | Active comparator | patients underwent TIPU with dorsal dartos flap interposition without spongioplasty Receives: Procedure: Tubularized Incised Plate (TIP) urethroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urethrocutaneous fistula
Rate of fistula
Measured: 12 months
meatal stenosis
Rate of metal stenosis
Measured: 12 months
glans dehiscence
Rate of glans dehiscence
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2023
- Study start1 Apr 2019
- Primary completion1 Jan 2023
- Study completion30 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypospadiasStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Daboos, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05960123
- Sponsor's protocol ID
- IRB 0000395-24-01-019
- Status last verified
- Jul 2023
- First submitted
- 10 Jul 2023
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of TIP Urethroplasty With Spongioplasty-Dartosoraphy Reinforcement in Pediatric Hypospadias
- ClinicalTrials.gov ID
- NCT05960123
- Acronym / sponsor ID
- IRB 0000395-24-01-019
- Conditions
- Hypospadias, Complication,Postoperative
- Keywords
- Distal and midpenile hypospadias, TIPU, Spongioplasty-dartosoraphy, pediatric HOSE
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 30 May 2023 (actual)
- First posted
- 25 Jul 2023 (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.
The study aimed to evaluation of Tubularized incised palate urethroplasty with spongioplasty-dartosoraphy reinforcement (group A) through comparing of functional and cosmetic results of this technique with the conventional TIP urethroplasty (group B).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group with Spongioplasty | Active comparator | Procedure: Tubularized Incised Plate (TIP) urethroplastypatients underwent TIPU with spongioplasty-Dartosoraphy reinforcement |
| Group without Spongioplasty | Active comparator | Procedure: Tubularized Incised Plate (TIP) urethroplastypatients underwent TIPU with dorsal dartos flap interposition without spongioplasty |
Who may qualify
- Ages
- 6 months to 14 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- lees than 14 years Distal hypospadias urethral plate size more than 6mm glans size more than 14 mm
Key exclusion criteria (1 listed)
- recurrent cases Proximal; hypospadias
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 |
|---|---|---|
| Tubularized Incised Plate (TIP) urethroplastytubularization of urethral plate with or without spongioplasty | Procedure or surgery | Group with Spongioplasty, Group without Spongioplasty |
Primary outcome
Urethrocutaneous fistula
Time frame: 12 months
Rate of fistula
meatal stenosis
Time frame: 12 months
Rate of metal stenosis
glans dehiscence
Time frame: 12 months
Rate of glans dehiscence
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 25 Jul 2023.
- Individual participant dataSharing planned: No
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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 Tubularized Incised Plate (TIP) urethroplasty in people with Hypospadias and Complication,Postoperative, run by Al-Azhar 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 1 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 25 Jul 2023. 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?
Urethrocutaneous fistula (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2023.