Comparing devices for sexual function in transgender patients after phalloplasty
Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients.
This study is testing whether internal or external devices can improve sexual function and satisfaction for transgender individuals who have had phalloplasty.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 2 sites (Ghent, East-Flanders and 1 other locations) |
| Trial ID | NCT05883553 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of internal erectile prostheses versus external devices (epithesis) in transgender and gender diverse individuals who have undergone phalloplasty. It aims to assess the usability and added value of these devices in enhancing sexual activity and satisfaction. Participants must have had phalloplasty at least one year prior and meet specific anatomical and functional criteria. The study is conducted at two prominent medical centers in Belgium and the Netherlands.
Who should consider this trial
Good fit: Ideal candidates are transgender or gender non-conforming individuals who have undergone phalloplasty and meet specific anatomical and functional criteria.
Not a fit: Patients who have not undergone phalloplasty or those with significant anatomical complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve sexual function and satisfaction for transgender individuals post-phalloplasty.
How similar studies have performed: Previous studies have indicated challenges with prosthesis durability in similar populations, highlighting the need for this comparative evaluation.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Ghent, East-Flanders and 1 other locations
- Department of Urology, University Hospital Ghent — Ghent, East-Flanders, Belgium (Recruiting)
- Department of Urology, Amsterdam University Medical Center — Amsterdam, North Holland, Netherlands (Not_yet_recruiting)
Study contacts
- Principal investigator: Nicolaas Lumen, MD, PhD — University Hospital, Ghent
- Study coordinator: Nicolaas Lumen, MD, PhD
- Email: Nicolaas.Lumen@UZGent.be
- Phone: 003293322276
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.