An interventional study of Small intestinal submucosa (SIS) graft urethroplasty and Autologous oral bucal mucosa graft urethroplasty in Urethral Stricture, Male, sponsored by Xiaoyong Zeng. Enrolling by invitation at 1 site in China. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by Xiaoyong Zeng · Not applicable, Interventional, and Treatment
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.
68 studies on the registry are indexed under Urethral Stricture; 23 are open to participants now.
This study's planned enrollment of 10 is below the median of 60 across 53 interventional studies indexed under Urethral Stricture.
Browse Urethral Stricture studies →This is the only study on the registry with Xiaoyong Zeng as lead sponsor.
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Exclusion Criteria:
this group will use a small intestinal submucosa graft in urethroplasty.
Procedure: Small intestinal submucosa (SIS) graft urethroplasty
this group will use an autologous oral bucal mucosa graft in urethroplasty.
Procedure: Autologous oral bucal mucosa graft urethroplasty
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.
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.
Urethral patency
A peri-urethrogram will be performed prior to catheter removal
Time frame: 4 weeks post-surgery
Serious adverse events
Frequency, type and severity of serious adverse events
Time frame: 4 weeks post-surgery
Voiding symptoms
Participants are filling out the International Prostate Symptom Score (IPSS) questionnaire.
Time frame: 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.
Time frame: 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
Time frame: Through study completion, an average of up to 5 years
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