Small Intestinal Submucosa Graft for Repair of Anterior Urethral Strictures

Launched by XIAOYONG ZENG · Dec 21, 2023

Keywords

ClinConnect Summary

This small, non-randomized interventional study in Wuhan, China is testing whether a graft made from small intestinal tissue (small intestinal submucosa, SIS) can safely and effectively be used for substitution urethroplasty in men with a single anterior urethral stricture, as an alternative to the usual buccal mucosa (gum/mouth) graft. About 10 adults are planned to enroll. Participants will be assigned to one of two urethroplasty approaches: SIS graft urethroplasty or the standard buccal mucosa graft urethroplasty, with no random assignment. The study aims to see if the SIS graft can keep the urethra open after surgery and to compare safety and longer-term outcomes over up to 5 years.

Who can join: men aged 18 or older with a single anterior urethral stricture longer than 2 cm but no more than 7 cm, who are undergoing substitution urethroplasty. Exclusions include very long or multiple strictures, prior radiation to the abdomen/pelvis, certain genital skin diseases, prior hypospadias repair, neurogenic urinary problems, major organ dysfunction, allergy to pig-derived materials, and other conditions that could affect safety or follow-up. What to expect if you enroll: after surgery, doctors will perform a peri-urethrogram (an imaging test) about 4 weeks later to check if the urethra is open before removing the catheter. Over the next up to 5 years, you would have tests to measure urine flow, urinary symptoms, imaging and scope exams to look for recurrence, and regular follow-up contacts. The study’s main goal is to see whether the SIS graft keeps the urethra open at 4 weeks, with additional safety and long-term results collected during the follow-up period. Trial is sponsored by Tongji Hospital with NCT06192654.

Gender

MALE

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)