Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients.

Summary

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 durability of penile epitheses in a TGD population, they may be a viable alternative to an internal penile prosthesis after phalloplasty. Penile lifters or splints, marketed as ElatorTM or ErektorTM, are commercially available and consist of two rigid rings connected by rigid metal rods. The biggest of two rings is placed around the base of the phallus, and the second ring is placed behind the coronal ridge. By connecting the rods to the ring at the base of the penis, tension and rigidity between the two rings is created, allowing the user to penetrate their partner and remove the device after intercourse.

The current study aims to extend the knowledge on these external devices by comparing them to the implantation of an internal penile prosthesis in post-phalloplasty transgender patients.

Conditions

• Transgenderism
• Erectile Dysfunction
• Prosthesis Durability
• Gender Dysphoria
• Sexual Dysfunction

Interventions

DEVICE

Usability and added value of device within sexual activity

Participants and there partners will be asked to use the device over the course of 4 months, during which both will provide answers to questionnaires on quality of relation and sexual life, and detailed questions on the usability and the added value of the used device during sexual activity along with overall satisfaction with the device.

Sponsors & Collaborators

• ELATOR/EREKTOR

  collaborator UNKNOWN

• University Hospital, Ghent

  lead OTHER

Principal Investigators

• Nicolaas Lumen, MD, PhD · University Hospital, Ghent

Study Design

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-05-17

Primary Completion

2025-12-31

Completion

2025-12-31

Countries

• Belgium
• Netherlands

Study Locations