Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients.

Launched by UNIVERSITY HOSPITAL, GHENT · May 22, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring two options for transgender and gender diverse individuals who have undergone phalloplasty, which is a surgery to create a male-like genital structure. The study is comparing the effectiveness of internal penile prostheses, which are devices implanted inside the body to help achieve an erection, with external devices known as penile epitheses. These external devices are designed to help with sexual intercourse without the need for surgery. The aim is to find out which method works better and has fewer complications.

To join the study, participants need to be transgender or gender non-conforming individuals who have had phalloplasty at least a year ago and have a partner willing to participate. They should also be interested in having penetrative sex but currently find it difficult without extra support. The trial is currently looking for participants, and those who take part can expect to receive support and information about both options while contributing to important research that may help others in similar situations.

Gender

FEMALE

Eligibility criteria

• 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.