Small Intestinal Submucosa Graft for Repair of Anterior Urethral Strictures

Urethral Stricture, Male Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06192654
• Other study ID #: NDXF-SIS
• Status: Enrolling by invitation
• Phase: N/A
• Start date: November 10, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: December 2023
• Source: Tongji Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 10
• Est. completion date: December 30, 2025
• Est. primary completion date: October 20, 2025
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Constriction, Pathologic
• Urethral Stricture
• Urethral Stricture, Male

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Tongji hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Xiaoyong Zeng

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Urethral patency	A peri-urethrogram will be performed prior to catheter removal	4 weeks post-surgery
Secondary	Serious adverse events	Frequency, type and severity of serious adverse events	4 weeks post-surgery
Secondary	Voiding symptoms	Participants are filling out the International Prostate Symptom Score (IPSS) questionnaire.	2 months up-to 5 years post-surgery
Secondary	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
Secondary	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