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RECRUITING

NCT05883553

Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients.

Sponsor: University Hospital, Ghent

View on ClinicalTrials.gov

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.

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-05-17

Completion Date

2025-12-31

Last Updated

2024-08-05

Healthy Volunteers

Yes

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.

Inclusion Criteria: * Transgender or gender non-conforming individuals diagnosed according to the DSM-5 diagnostic criteria for gender dysphoria. * Patients have undergone phalloplasty as a form of genital gender affirming surgery. * ≥ 1 year after phalloplasty (any type of flap combination is allowed), performed at the Ghent University Hospital or Amsterdam UMC. * ≥ 3 months after coronaplasty and having reasonably pronounced coronal ridge, as defined by the surgeons' expert opinion (This criterion is only obligatory in the eptithesis group, not in the prosthesis group). * Anatomic penile length and girth as defined by the surgeons' expert opinion. * Absence of urethral stricture or other structural problem resulting in voiding dysfunction. * Normal uroflowmetry and post-void residue * Regain of at least minimal protective sensation up to the tip of the phallus as defined by Semmes-Weinstein monofilament testing. * Established (primary) sexual relationship with partner who is willing to take part in the study. * Both patient and partner have interest in penetrative sexual intercourse. * Patient is unable to penetrate the partner (anal or vaginal) adequately sexually without the aid of supportive measures (condom, taping, penile sleeve, penile epithesis or any other measure defined as supportive by the investigators). * Fit and eligible for erection prosthesis surgery, based on the surgeons' expert opinion. * No history of erection prosthesis surgery. * No interest in or fear of prosthesis surgery making this option obsolete (This criterion is only obligatory in the eptithesis group, not in the prosthesis group) * Treatment naïve in the use of the Elatortm or Erektortm epithesis. * Voluntarily signed written informed consent according to the rules of Good Clinical Practice (Declaration of Helsinki) and national regulations. Exclusion Criteria: * Cisgender patients treated with phalloplasty various reasons. * Post-metoidioplasty patients (metoidioplasty as step-up to performed phalloplasty is allowed). * Absence of coronaplasty or coronaplasty performed \< 3 months ago or coronaplasty did not leave sufficiently pronounced coronal ridge as defined by the surgeons' expert opinion (This criterion is only obligatory in the epithesis group, not in the prosthesis group) * Penile dimensions are not anatomic (e.g. too small or too large). * Underlying LUTDs requiring further investigation and/or treatment. * Inadequate protective sensation in the penis. * No established (sexual) partner and/or partner is not willing to take part in the study. * Patient and/or partner have no interest in penetrative sexual intercourse.

Locations (2)

Department of Urology, University Hospital Ghent

Ghent, East-Flanders, Belgium

Department of Urology, Amsterdam University Medical Center

Amsterdam, North Holland, Netherlands