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The field of research for this study is tissue engineering and the utilization of a small intestinal submucosa graft as a substitute biomaterial for conventional buccal mucosa in substitution urethroplasty of anterior urethral strictures.
Urethral stricture refers to the abnormal narrowing of the urethral lumen resulting from fibrosis that affects the urethral epithelium and underlying corpus spongiosum. The management of urethral stricture longer than 2 cm a major therapeutic challenge in clinics. Currently available surgical techniques require harvesting of grafts from autologous sites. However, there are numerous disadvantages associated with autografts, such as limited availability and variable quality, donor site morbidity, increased risk of surgical complications; thereby the application of this method is especially limited for large defects.
The hypothesis of this study is that the small intestinal submucosa graft can be used as an alternative biomaterial to buccal mucosa for substitution urethroplasty in urethral stricture patients. The aim of this study is to assess safety and efficacy of surgical treatment of patients with anterior urethral stricture using a small intestinal submucosa graft. The follow-up time for all patients in this study was 5 years. The follow-up regimen includes retrograde and pericatheter urethrography, voiding cystourethrography, uroflowmetry, cystoscopy, and voiding symptoms monitoring. Telephone follow-up will take place in between these assessments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Small intestinal submucosa (SIS) graft urethroplasty | Experimental | this group will use a small intestinal submucosa graft in urethroplasty. |
|
| Autologous oral bucal mucosa graft urethroplasty | Active Comparator | this group will use an autologous oral bucal mucosa graft in urethroplasty. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Small intestinal submucosa (SIS) graft urethroplasty | Procedure | Standard technique of doing a substitution urethroplasty with no modification to the surgical steps. Instead of an autologous oral bucal mucosa graft, the small intestinal submucosa graft is sutured to the healty urethral area after incision of the urethra at the stricture location. |
| Measure | Description | Time Frame |
|---|---|---|
| Urethral patency | A peri-urethrogram will be performed prior to catheter removal | 4 weeks post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Serious adverse events | Frequency, type and severity of serious adverse events | 4 weeks post-surgery |
| Voiding symptoms | Participants are filling out the International Prostate Symptom Score (IPSS) questionnaire. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tongji hospital | Wuhan | Hubei | China |
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| ID | Term |
|---|---|
| D014525 | Urethral Stricture |
| ID | Term |
|---|---|
| D014524 | Urethral Obstruction |
| D014522 | Urethral Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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|
| Autologous oral bucal mucosa graft urethroplasty | Procedure | Standard technique of doing a substitution urethroplasty with no modification to the surgical steps. The autologous oral bucal mucosa graft is sutured to the healty urethral area after incision of the urethra at the stricture location. |
|
| 2 months up-to 5 years post-surgery |
| Urine flow | Participants are undergoing an uroflowmetry. This test measures the volume of urine released from the body, the speed with which it is released, and how long the release takes. | 2 months up-to 5 years post-surgery |
| Anatomic recurrence of urethral stricture observed by cystoscopy 、 Retrograde urethrography(RUG)、 Voiding cystourethrography(VCUG) | Full assessment of the urethral lumen after the surgery | Through study completion, an average of up to 5 years |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |