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Compares treatment options for Transgenderism
Official title Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients.
ClinicalTrials.gov ID: NCT05883553
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- Anatomic penile length and girth as defined by the surgeons' expert opinion.
You likely can't join if
- 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...
- 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.
See the full eligibility 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ghent, East-Flanders, Belgium
- Amsterdam, North Holland, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ghent, East-Flanders, Belgium; Amsterdam, North Holland, Netherlands. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.