Clinical trial NCT06192654: Small Intestinal Submucosa Graft for Repair of Anterior Urethral Strictures
Official title: Small Intestinal Submucosa Graft as an Alternative to Conventional Buccal Mucosa for Substitution Urethroplasty of Anterior Urethral Strictures
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Urethral Stricture, Male
Keywords: urethral stricture
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 10
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Urethral patency
timeFrame: 4 weeks post-surgery
Secondary outcomes:
measure: Serious adverse events
timeFrame: 4 weeks post-surgery
measure: Voiding symptoms
timeFrame: 2 months up-to 5 years post-surgery
measure: Urine flow
timeFrame: 2 months up-to 5 years post-surgery
measure: Anatomic recurrence of urethral stricture observed by cystoscopy 、 Retrograde urethrography(RUG)、 Voiding cystourethrography(VCUG)
timeFrame: Through study completion, an average of up to 5 years
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Tongji hospital
state: Hubei
Study officials:
References: