NCT04357080

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 19, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 22, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

July 15, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 29, 2020

Completed
Last Updated

January 13, 2021

Status Verified

April 1, 2020

Enrollment Period

1 month

First QC Date

April 19, 2020

Last Update Submit

January 11, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • urethral restricture rate

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

    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

    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).

Study Arms (2)

Case

Patients with urethral stricture recurrence

Procedure: Urethroplasty

Control

Patients with normal, patent urethra

Procedure: Urethroplasty

Interventions

UrethroplastyPROCEDURE

Augmentation Anterior Urethroplasty Using Dorsal Onlay Buccal Mucosal Graft

CaseControl

Eligibility Criteria

Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale of any age
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • patients with incomplete medical records or follow-up informations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology Department, Al-Azhar University Hospital

Cairo, 11633, Egypt

Location

MeSH Terms

Conditions

Urethral Stricture

Condition Hierarchy (Ancestors)

Urethral ObstructionUrethral DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Urology and Andrology

Study Record Dates

First Submitted

April 19, 2020

First Posted

April 22, 2020

Study Start

July 15, 2020

Primary Completion

August 15, 2020

Study Completion

August 29, 2020

Last Updated

January 13, 2021

Record last verified: 2020-04

Locations