Study of SEBBIN Silicone Gel-filled Testicular Implants for Patients Needing One or Two Testicular Prostheses Including Cisgender and Transgender Adults and Children

What this Trial Is About

This research aims to analyze both short and long term outcomes and patient satisfaction after receiving silicone gel-filled testicular implants made by Groupe SEBBIN. The study includes patients of any age who require testicular implant placement due to conditions such as testicular agenesis, atrophy, undescended testicle, tumor, infection, trauma, or as part of gender reassignment surgery. Since testicular loss can cause psychological distress, the study focuses on understanding complications and quality of life impacts related to these implants. The study observes the placement of one or two sterile, bio-compatible silicone gel-filled testicular prostheses manufactured by SEBBIN. These implants are used during surgery upon patient request and are intended for various medical or gender affirmation reasons. Both cisgender and transgender patients receiving these implants are included, with no experimental treatment but monitoring of the implants safety and performance over time. Participants will be followed for up to two years after surgery to track complications within 90 days post-operation and long term at two years. Researchers will collect data on complication rates and grades as well as patient-reported outcomes including self-esteem, scrotal body image, and satisfaction with the prosthesis using questionnaires at baseline and multiple intervals up to 24 months. The study monitors safety and quality of life changes to provide comprehensive clinical evaluations of these implants.

Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants