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CompletedNCT04357080Updated Aug 14, 2026

Factors Predicting Urethral Stricture Recurrence After Dorsal Onlay Augmented, Buccal Mucosal Graft Urethroplasty

An observational study in Urethral Stricture, sponsored by Al-Azhar University. Completed at 1 site in Egypt. Open to male participants. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Al-Azhar University · Observational

Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
266
Sex
Male
01

Study 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. 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.

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Conditions studied

  • Urethral Stricture

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03

In context

Urethral Stricture

68 studies on the registry are indexed under Urethral Stricture; 23 are open to participants now.

This study's enrollment of 266 is above the median of 188 across 10 observational studies indexed under Urethral Stricture.

Browse Urethral Stricture studies →

Lead sponsor

Al-Azhar University is the lead sponsor of 505 studies on the registry; 167 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Sampling method
Non-probability sample

Study population

patients who underwent augmented anterior urethroplasty with buccal mucosal graft at Al-Azhar University Hospital in the past 10 years

Inclusion criteria

  • patients who will be 2 years or more out of surgery

Exclusion criteria

Exclusion Criteria:

  • patients with incomplete medical records or follow-up informations
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Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
266 participants (actual)
Patient registry
No

Groups and cohorts

  • Case

    Patients with urethral stricture recurrence

    Procedure: Urethroplasty

  • Control

    Patients with normal, patent urethra

    Procedure: Urethroplasty

Interventions

  • ProcedureUrethroplasty

    Augmentation Anterior Urethroplasty Using Dorsal Onlay Buccal Mucosal Graft

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What researchers measure

Primary outcomes

  1. urethral restricture rate

    The presence of radiologic and endoscopic features of urethral stricture recurrence, as diagnosed by urethrography and cystoscopy during follow-up.

    Time frame: At any time from date of surgery until the last follow-up visit (up to 10 years)

  2. Time to urethral restricture.

    will be calculated from the date of surgery until the date restricture diagnosis

    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).

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Study locations

1 site
  • Urology Department, Al-Azhar University Hospital
    Cairo, 11633, Egypt
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References and documents

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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04357080
Lead sponsor
Al-Azhar University
Responsible party
Abul-fotouh Ahmed (Professor of Urology and Andrology, Al-Azhar University) — Principal investigator
First posted
Apr 22, 2020
Start date
Jul 15, 2020
Primary completion
Aug 15, 2020
Completion
Aug 29, 2020
Last update
Aug 14, 2026

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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