Actively Recruiting

Phase Not Applicable
Age: 18Years +
FEMALE
Healthy Volunteers
NCT05883553

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

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

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
Not Eligible

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

1
2
3
+1

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

Loading map...

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