Comparing External Epithesis and Internal Prosthesis for Sexual Function in Post-phalloplasty Transgender Women

What this Trial Is About

This research explores options for transgender and gender diverse individuals who have undergone phalloplasty, a surgery to create masculine external genitalia. The study compares the use of an internal erectile prosthesis, which is currently the main method to achieve penile rigidity but has high complication rates, with external devices called epitheses, which may offer an alternative without surgery. The goal is to better understand the usability, satisfaction, and complications of these options in this population. Participants will receive either an Elator device, an external penile lifter measured to fit their phallus, or a Zephyr ZSI 475 FTM internal erection prosthesis, which is the current standard of care. The prosthesis group will follow a healing phase of at least six weeks. Both groups will use their assigned device over four months while completing questionnaires about sexual activity, quality of relationship, satisfaction, and usability. Researchers will monitor complications and other health outcomes throughout the study. During the study, participants and their partners will answer questionnaires at baseline and at various points over four months regarding sexual function, satisfaction, relationship quality, and urinary symptoms. Researchers will also assess physical parameters and track complications within 90 days after surgery or device use. The study aims to measure the percentage of patients choosing each device and the ability to perform penetrative intercourse, with ongoing monitoring of safety and quality of life over the study period.

Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients.