Actively Recruiting
Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients.
Led by University Hospital, Ghent · Updated on 2024-08-05
40
Participants Needed
2
Research Sites
137 weeks
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
E
ELATOR/EREKTOR
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Transgender or gender non-conforming individuals diagnosed with gender dysphoria according to the DSM-5 criteria
- Have undergone phalloplasty as genital gender-affirming surgery
- At least 1 year has passed since phalloplasty, performed at Ghent University Hospital or Amsterdam UMC
- At least 3 months have passed since coronaplasty with a reasonably pronounced coronal ridge (required only for the epithesis group)
- Anatomic penile length and girth as determined by surgeons
- No urethral stricture or other structural issues causing voiding problems
- Normal uroflowmetry and post-void urine residue
- Regained at least minimal protective sensation up to the tip of the phallus
- Have a primary sexual partner willing to participate in the study
- Both patient and partner are interested in penetrative sexual intercourse
- Patient is unable to penetrate partner adequately without supportive measures
- Fit and eligible for erection prosthesis surgery as per surgeons' opinion
- No history of erection prosthesis surgery
- No fear or disinterest in prosthesis surgery (required only for the epithesis group)
- No prior use of ElatorTM or ErektorTM epithesis
- Signed informed consent according to regulations
You will not qualify if you...
- Cisgender patients treated with phalloplasty for various reasons
- Patients who have had only metoidioplasty (unless as a step-up to phalloplasty)
- No coronaplasty or coronaplasty less than 3 months ago or insufficient coronal ridge (required only for the epithesis group)
- Penile dimensions not anatomic (too small or too large)
- Underlying lower urinary tract disorders requiring further treatment
- Inadequate protective sensation in the phallus
- No established sexual partner or partner unwilling to participate
- Patient or partner not interested in penetrative sexual intercourse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
Department of Urology, University Hospital Ghent
Ghent, East-Flanders, Belgium, 9000
Actively Recruiting
2
Department of Urology, Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands, 1081
Not Yet Recruiting
Research Team
N
Nicolaas Lumen, MD, PhD
CONTACT
W
Wietse Claeys, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here