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Study identifier: NCT05883553 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients.

Condition: Transgenderism · Erectile Dysfunction · Prosthesis Durability  ·  Sponsor: University Hospital, Ghent

PhaseNA
Planned participants40
Who can joinFemale, 18 Years to no upper limit
Healthy volunteersYes

About this study

Transgender and gender diverse (TGD) individuals most often choose for phalloplasty as a means to create masculine external genitalia. The neophallus created in phalloplasty is usually insufficient for penetrative sexual intercourse due to the lack of erectile structures. Therefore, implantation of an internal erectile prosthesis or use of an external device or epithesis is required. Internal prostheses are the main method for attaining penile rigidity after phalloplasty, but they carry a high risk of complications. Previous research has shown that up to 22% of prostheses for cisgender men were explanted due to various reasons, including infection, erosion, and malfunction within 20 months. The lack of reliable and durable erectile devices leads to a large proportion of patients either choosing phalloplasty but never going for the placement of an erectile prosthesis or completely abandoning the idea of GGAS under the form of phalloplasty. Secondarily, TGD individuals may be concerned about complication rates and likely need for additional surgeries associated with penile implant surgery. Therefore, alternative options for transgender and gender non-conforming patients after phalloplasty are needed. These alternatives may be surgical or non-surgical. External penile epitheses or penile splints were originally designed for cisgender men with erectile dysfunction but have been used experimentally by post-phalloplasty transgender men. While there is no data on the usability and…

This description comes directly from the study's public registry record.

Talk to the study team

Nicolaas Lumen, MD, PhD  ·  003293322276  ·  Nicolaas.Lumen@UZGent.be

Wietse Claeys, MD  ·  003293322276  ·  Wietse.Claeys@UGent.be

Always discuss trial participation with your own doctor first.

Locations (2)

Department of Urology, University Hospital GhentGhent, East-Flanders, BelgiumRecruiting
Department of Urology, Amsterdam University Medical CenterAmsterdam, North Holland, NetherlandsNot Yet Recruiting

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Source record: clinicaltrials.gov/study/NCT05883553