Small Intestinal Submucosa Graft for Repair of Anterior Urethral Strictures

Small Intestinal Submucosa Graft as an Alternative to Conventional Buccal Mucosa for Substitution Urethroplasty of Anterior Urethral Strictures

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Urethral Stricture, Male
• Intervention / Treatment: Procedure: Small intestinal submucosa (SIS) graft urethroplasty; Procedure: Autologous oral bucal mucosa graft urethroplasty

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 Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Tongji Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Small intestinal submucosa (SIS) graft urethroplasty; this group will use a small intestinal submucosa graft in urethroplasty.	Procedure: 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.
Active Comparator: Autologous oral bucal mucosa 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. The autologous oral bucal mucosa graft is sutured to the healty urethral area after incision of the urethra at the stricture location.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urethral patency	A peri-urethrogram will be performed prior to catheter removal	4 weeks post-surgery

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Xiaoyong Zeng

Study record dates

Study Major Dates

• Study Start (Actual): November 10, 2023
• Primary Completion (Estimated): October 20, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: December 21, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): January 5, 2024

Study Record Updates

• Last Update Posted (Actual): January 5, 2024
• Last Update Submitted That Met QC Criteria: December 21, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: urethral stricture
• Additional Relevant MeSH Terms: Urologic Diseases; Pathological Conditions, Anatomical; Urethral Diseases; Urethral Obstruction; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Constriction, Pathologic; Urethral Stricture
• Other Study ID Numbers: NDXF-SIS

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No