Small Intestinal Submucosa Graft for Repair of Anterior Urethral Strictures

Not Applicable

• Conditions: Urethral Stricture, Male
• Interventions: Procedure: Autologous oral bucal mucosa graft urethroplasty; Procedure: Small intestinal submucosa (SIS) graft urethroplasty

• Registration Number: NCT06192654
• Lead Sponsor: Xiaoyong Zeng

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2023-11-10
• Status Verified: 2023-12
• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2023-12-21
• Last Update Submitted: 2023-12-21
• Study First Posted: 2024-01-05
• Last Update Posted: 2024-01-05
• Primary Completion: 2025-10-20
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Male
• Target Recruitment: 10

Inclusion Criteria

• Patients signed informed consent form
• Patients with a single, longer than 2.0 cm and shorter than or equal to 7.0 cm anterior urethral stricture
• Patients undergoing substitution urethroplasty for urethral stricture.

Exclusion Criteria

• Patients without surgical indication
• Subtotal and total urethral strictures
• Radiation therapy to the abdomen or pelvis
• Lichen sclerosis related strictures
• Patients with previous hypospadias repair
• Neurogenic urinary tract disorders
• Mental disorders
• Patients with a known biologic sensitivity or a cultural aversion to the use of porcine materials.
• Patients with severe dysfunction of heart, lung, liver, kidney and other important organs , endocrine system and blood system.
• Patient with malignant tumor
• Patient who cannot be regularly examined due to any circumstances
• Any clinical state which does not ensure the safe implementation of study procedure (investigator's view)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous oral bucal mucosa graft urethroplasty	Autologous oral bucal mucosa graft urethroplasty	this group will use an autologous oral bucal mucosa graft in urethroplasty.
Small intestinal submucosa (SIS) graft urethroplasty	Small intestinal submucosa (SIS) graft urethroplasty	this group will use a small intestinal submucosa graft in urethroplasty.

Primary Outcome Measures

Name	Time	Method
Urethral patency	4 weeks post-surgery	A peri-urethrogram will be performed prior to catheter removal

Secondary Outcome Measures

Name	Time	Method
Serious adverse events	4 weeks post-surgery	Frequency, type and severity of serious adverse events
Voiding symptoms	2 months up-to 5 years post-surgery	Participants are filling out the International Prostate Symptom Score (IPSS) questionnaire.
Urine flow	2 months up-to 5 years post-surgery	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.
Anatomic recurrence of urethral stricture observed by cystoscopy 、 Retrograde urethrography(RUG)、 Voiding cystourethrography(VCUG)	Through study completion, an average of up to 5 years	Full assessment of the urethral lumen after the surgery

Trial Locations

Locations (1)

Tongji hospital; 🇨🇳 Wuhan, Hubei, China