Small Intestinal Submucosa Graft for Repair of Anterior Urethral Strictures

NCT ID: NCT06192654

Last Updated: 2024-01-05

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-10
• Study Completion Date: 2025-12-30

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.

Conditions

Urethral Stricture, Male

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Small intestinal submucosa (SIS) graft urethroplasty

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

Group Type: EXPERIMENTAL

Small intestinal submucosa (SIS) graft urethroplasty

Intervention Type: 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.

Autologous oral bucal mucosa graft urethroplasty

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

Group Type: ACTIVE_COMPARATOR

Autologous oral bucal mucosa graft urethroplasty

Intervention Type: 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.

Interventions

Small intestinal submucosa (SIS) 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.

Intervention Type: PROCEDURE

Autologous oral bucal mucosa graft urethroplasty

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.

Intervention Type: PROCEDURE

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Xiaoyong Zeng

OTHER

Sponsor Role: lead

Responsible Party

Xiaoyong Zeng

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Tongji hospital

Wuhan, Hubei, China

Countries

China

Other Identifiers

NDXF-SIS

Identifier Type: -

Identifier Source: org_study_id