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This study aims to compare the penile skin graft and buccal mucosal graft for substitution of long anterior urethral strictures using one-sided dorsal perineal approach.
Since previous studies were:
This study aims to compare the PSG and BMG for substitution of long anterior urethral strictures using one-sided dorsal perineal approach.
The investigators hypothesize that:
❶ Conducting a well-designed prospective, randomized study can help identify which technique is better than the other.
❷ Using the one-side dorsal approach can improve the outcomes of both techniques and identify their advantages and disadvantages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSG group | Active Comparator | The group of patients who will undergo penile skin graft substitituion of long anterior urethral stricture |
|
| BMG group | Active Comparator | The group of patients who will undergo buccal mucosal graft substitituion of long anterior urethral stricture |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Penile skin graft substituttion urethroplasty | Procedure | substitution of long anterior urethral strictures using one-sided dorsal perineal approach |
|
| Measure | Description | Time Frame |
|---|---|---|
| The degree of urethral lumen patency. | Patent urethra as evidenced by uroflowmetry and retrograde urethrography +/- urethroscopy | through study completion, an average of 1 year. |
| Measure | Description | Time Frame |
|---|---|---|
| Lower urinary tract symptoms improvement | lower urinary tract symptoms as assessed by the international prostate symptom score, ranging from 0 to 35, where scores from 0-7 are mild, from 8-19 are moderate, from 20-35 are severe symptoms. | 6 months |
| Erectile function assessment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mohamed Anwar, A. lecturer | Contact | 00201155678282 | m0anwar2005@gmail.com | |
| Ahmed Alrefaey, lecturer | Contact | 00201149394121 | urologydepartment@azhar.edu.eg |
| Name | Affiliation | Role |
|---|---|---|
| Ahmed Fahim, professor | Urology department, Al-Azhar university, Cairo, Egypt | Study Director |
| Mostafa Ezzeldein, professor | Urology department, Al-Azhar university, Cairo, Egypt | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Azhar urology department, Al-Azhar university hospitals | Recruiting | Cairo | 11511 | Egypt |
Patients' data sheet, patient consent forms through my E-mail: m0anwar2005@gmail.com
The data will be available after 1 year, and for 2 years.
My e-mail: m0anwar2005@gmail.com
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jun 30, 2022 | Sep 23, 2023 |
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Two-arm parallel assignment. The first arm will be operated using penile skin grafts, The second arm will be operated using buccal mucosal grafts.
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| Buccal Mucosal Graft substitution urethroplasty | Procedure | substitution of long anterior urethral strictures using one-sided dorsal perineal approach |
|
sexual function as assessed by the international index of erectile function-5 questionnaire, ranging from 5-25, where 22-25 is normal, 17-21 is mild ED, 12-16 is mild to moderate ED, 8-11 is moderate ED, and 5-7 is severe ED. |
| 6 months |
| Prot_000.pdf |
| ID | Term |
|---|---|
| D014525 | Urethral Stricture |
| ID | Term |
|---|---|
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
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