Urethral StrictureNCT04357080
Factors Predicting Urethral Stricture Recurrence After Dorsal Onlay Augmented, Buccal Mucosal Graft Urethroplasty
An observational study of Urethral Stricture, run by Al-Azhar University at 1 site in Egypt.
Trial summary
In this observational study, the investigators will evaluate potential risk factors associated with urethral stricture recurrence after augmentation anterior urethroplasty using dorsal onlay buccal mucosal Graft during the past 10 years. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Urethral Stricture
- What is being tested?
- Urethroplasty
- Type of treatment
- Surgery or procedure
- How many people
- 266 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jul 2020to 29 Aug 2020
- Phase
- Observational
- 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 Any age
- Men only
- Child, Adult, Older adult
Study population: patients who underwent augmented anterior urethroplasty with buccal mucosal graft at Al-Azhar University Hospital in the past 10 years
Who may be able to join
- patients who will be 2 years or more out of surgery
Who cannot join
- patients with incomplete medical records or follow-up informations
Trial locations and contacts
1 site in 1 country.
About this study
In this observational study, the investigators will evaluate potential risk factors associated with urethral stricture recurrence after augmentation anterior urethroplasty using dorsal onlay buccal mucosal Graft during the past 10 years. Patients' medical files will be reviewed for data relevant to demographics, clinical and operative characteristics. data will be analyzed using the appropriate statistical tests and the independent predictors of urethroplasty outcome will be identified.
Read the detailed description
In this series, the investigators will study different factors related to the stricture and to the patients to identify the independent predictors of urethral stricture recurrence after augmentation anterior urethroplasty using dorsal onlay buccal mucosal graft.
A retrospective review of medical records will be performed to identify patients who underwent augmented anastomotic anterior urethroplasty with dorsal onlay graft at Al-Azhar University Hospitals in Egypt since 2010. Patients will be included only if they were two or more years out of surgery. The data will be recorded without patients' identification.
Data to be collected are patient age, body mass index (BMI), smoking status, diabetes status, overall comorbidity, stricture etiology, prior endoscopic treatment and open urethroplasty, urethral stricture length and location, degree of urethral obliteration, urethral plate width, presence and degree of spongiofibrosis. estimated intraoperative blood loss, catheter size, overall operative time, hospital stay and early postoperative complications.
The diagnosis of urethral stricture recurrence is based on the radiological and endoscopic features of stricture recurrence. Time to recurrence will be calculated from the date of surgery till the date restricture diagnosis.
Univariate and multivariate regression analysis will be performed and factors predicting urethral stricture recurrence will be identified.
- Conditions
- Urethral Stricture
- Being tested
- Urethroplasty
- Medical subject headings
- Urethral Stricture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UrethroplastyProcedure or surgery
Augmentation Anterior Urethroplasty Using Dorsal Onlay Buccal Mucosal Graft
| Study group | Role | What they receive |
|---|---|---|
| Case | Patients with urethral stricture recurrence Receives: Procedure: Urethroplasty | |
| Control | Patients with normal, patent urethra Receives: Procedure: Urethroplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
urethral restricture rate
The presence of radiologic and endoscopic features of urethral stricture recurrence, as diagnosed by urethrography and cystoscopy during follow-up.
Measured: At any time from date of surgery until the last follow-up visit (up to 10 years)
Time to urethral restricture.
will be calculated from the date of surgery until the date restricture diagnosis
Measured: The time from urethroplasty surgery until the time of urethral restricure diagnosis (at any follow-up time point, up to 10 years), as recorded in patients medical files).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2020
- Study start15 Jul 2020
- Primary completion15 Aug 2020
- Study completion29 Aug 2020
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 Urethral StrictureStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abul-fotouh Ahmed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04357080
- Sponsor's protocol ID
- Uro_Azhar_4_020
- Status last verified
- Apr 2020
- First submitted
- 19 Apr 2020
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Shalkamy O, Abdelazim H, Elshazly A, Soliman A, Agha M, Tagreda I, Hindawy M, Kotb A, Farid M, Ahmed AF. Factors Predicting Urethral Stricture Recurrence after Dorsal Onlay Augmented, Buccal Mucosal Graft Urethroplasty. Urol Int. 2021;105(3-4):269-277. doi: 10.1159/000512065. Epub 2020 Dec 17.
PubMed 33333534
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Predicting Urethral Stricture Recurrence After Dorsal Onlay Augmented, Buccal Mucosal Graft Urethroplasty
- ClinicalTrials.gov ID
- NCT04357080
- Acronym / sponsor ID
- Uro_Azhar_4_020
- Conditions
- Urethral Stricture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 15 Jul 2020 (actual)
- Primary completion
- 15 Aug 2020 (actual)
- Study completion
- 29 Aug 2020 (actual)
- First posted
- 22 Apr 2020 (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.
In this observational study, the investigators will evaluate potential risk factors associated with urethral stricture recurrence after augmentation anterior urethroplasty using dorsal onlay buccal mucosal Graft during the past 10 years. Patients' medical files will be reviewed for data relevant to demographics, clinical and operative characteristics. data will be analyzed using the appropriate statistical tests and the independent predictors of urethroplasty outcome will be identified.
Detailed description
In this series, the investigators will study different factors related to the stricture and to the patients to identify the independent predictors of urethral stricture recurrence after augmentation anterior urethroplasty using dorsal onlay buccal mucosal graft.
A retrospective review of medical records will be performed to identify patients who underwent augmented anastomotic anterior urethroplasty with dorsal onlay graft at Al-Azhar University Hospitals in Egypt since 2010. Patients will be included only if they were two or more years out of surgery. The data will be recorded without patients' identification.
Data to be collected are patient age, body mass index (BMI), smoking status, diabetes status, overall comorbidity, stricture etiology, prior endoscopic treatment and open urethroplasty, urethral stricture length and location, degree of urethral obliteration, urethral plate width, presence and degree of spongiofibrosis. estimated intraoperative blood loss, catheter size, overall operative time, hospital stay and early postoperative complications.
The diagnosis of urethral stricture recurrence is based on the radiological and endoscopic features of stricture recurrence. Time to recurrence will be calculated from the date of surgery till the date restricture diagnosis.
Univariate and multivariate regression analysis will be performed and factors predicting urethral stricture recurrence will be identified.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case | – | Procedure: UrethroplastyPatients with urethral stricture recurrence |
| Control | – | Procedure: UrethroplastyPatients with normal, patent urethra |
Who may qualify
- Sex
- Male only
- Age groups
- Child, Adult, Older adult
- Study population
- patients who underwent augmented anterior urethroplasty with buccal mucosal graft at Al-Azhar University Hospital in the past 10 years
Key inclusion criteria (1 listed)
- patients who will be 2 years or more out of surgery
Key exclusion criteria (1 listed)
- patients with incomplete medical records or follow-up informations
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 |
|---|---|---|
| UrethroplastyAugmentation Anterior Urethroplasty Using Dorsal Onlay Buccal Mucosal Graft | Procedure or surgery | Case, Control |
Primary outcome
urethral restricture rate
Time frame: At any time from date of surgery until the last follow-up visit (up to 10 years)
The presence of radiologic and endoscopic features of urethral stricture recurrence, as diagnosed by urethrography and cystoscopy during follow-up.
Time to urethral restricture.
Time frame: The time from urethroplasty surgery until the time of urethral restricure diagnosis (at any follow-up time point, up to 10 years), as recorded in patients medical files).
will be calculated from the date of surgery until the date restricture diagnosis
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 14 Aug 2026.
- Background: PubMed 33333534Shalkamy O, Abdelazim H, Elshazly A, Soliman A, Agha M, Tagreda I, Hindawy M, Kotb A, Farid M, Ahmed AF. Factors Predicting Urethral Stricture Recurrence after Dorsal Onlay Augmented, Buccal Mucosal Graft Urethroplasty. Urol Int. 2021;105(3-4):269-277. doi: 10.1159/000512065. Epub 2020 Dec 17.
- Safety and Efficacy of Fluoroscopy-Free Technique During Retrograde Intrarenal Surgery for Renal Stones: A Prospective, Randomized, Controlled, Noninferiority TrialLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Urethral Stricture, 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 14 Aug 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?
urethral restricture rate (time frame: At any time from date of surgery until the last follow-up visit (up to 10 years)). 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 NCT04357080, 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 14 Aug 2026.