Small Intestinal Submucosa Graft for Repair of Anterior Urethral Strictures

Xiaoyong Zeng

Status: Invitation-only

Conditions: Urethral Stricture, Male

Treatments: Procedure: Autologous oral bucal mucosa graft urethroplasty; Procedure: Small intestinal submucosa (SIS) graft urethroplasty

Study type: Interventional

Funder types: Other

Identifiers

NCT06192654

NDXF-SIS

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

Small intestinal submucosa (SIS) graft urethroplasty

Experimental group

Description:

this group will use a small intestinal submucosa graft in urethroplasty.

Treatment:

Procedure: Small intestinal submucosa (SIS) graft urethroplasty

Autologous oral bucal mucosa graft urethroplasty

Active Comparator group

Description:

this group will use an autologous oral bucal mucosa graft in urethroplasty.

Treatment:

Procedure: Autologous oral bucal mucosa graft urethroplasty