Anterior Urethral Stricture, Male
Conditions
Keywords
urethral stricture, urethroplasty, BMG, PSG, penile skin
Brief summary
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.
Detailed description
Since previous studies were: * Retrospective and very few were prospective randomized studies * Some studies were done on lichen sclerosis cases that have an adverse effect on the PSG outcome. * The follow-up duration was longer for PSG patients. * Stricture length was usually longer for PSG cases. 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.
Interventions
PROCEDUREPenile skin graft substituttion urethroplasty
substitution of long anterior urethral strictures using one-sided dorsal perineal approach
PROCEDUREBuccal Mucosal Graft substitution urethroplasty
substitution of long anterior urethral strictures using one-sided dorsal perineal approach
Sponsors
Al-Azhar University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Two-arm parallel assignment. The first arm will be operated using penile skin grafts, The second arm will be operated using buccal mucosal grafts.
Eligibility
Sex/Gender
MALE
Age
5 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The study will include patients with long segment anterior urethral stricture (\>2 cm).
Exclusion criteria
* Urethro-cutaneous fistula, urethral abscess or diverticulum. * A scarred and unsalvageable urethral plate or scarred perineum. * Lichen sclerosis (Balanitis xerotica obliterans). * Unhealthy/unavailable buccal mucosa.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The degree of urethral lumen patency. | through study completion, an average of 1 year. | Patent urethra as evidenced by uroflowmetry and retrograde urethrography +/- urethroscopy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lower urinary tract symptoms improvement | 6 months | 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. |
| Erectile function assessment | 6 months | 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. |
Countries
Egypt
Contacts
Primary ContactMohamed Anwar, A. lecturer
Backup ContactAhmed Alrefaey, lecturer
Outcome results
None listed