EPITHESIS VERSUS PROSTHESIS IN POST-PHALLOPLASTY TRANSGENDER PEOPLE
- Conditions
- Erectiele functie, seksuele functionerenErectile dysfunctionsexual problems
- Registration Number
- NL-OMON56636
- Lead Sponsor
- niversitair Ziekenhuis Gent
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Not specified
- Target Recruitment
- 50
- Participant and partner age >= 18 years.
- Transgender or gender non-conforming individuals diagnosed according to the
DSM-5 diagnostic criteria for gender dysphoria.
- Participants 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).
- Absence of urethral stricture or other structural problem resulting in
voiding dysfunction.
- Established (primary) sexual relationship with partner who is willing to take
part in the study.
- Participant 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.
- Treatment naïve in the use of the Elatortm or Erektortm epithesis.
- Participant age < 18 years. - 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. - Participant does not have
sufficent sensations in the phallus - No established (sexual) partner and/or
partner is not willing to take part in the study. - Participant and/or partner
have no interest in penetrative sexual intercourse.
Warnings as provided by the manufacturer, adjust and summarised according to
the needs of the target study population:
1. Always apply a water or silicone based lubricant to all areas of the phallus
in contact with the epithesis.
2. To make penetration easier at the beginning of intercourse, always prepare
with adequate foreplay.
3. Should any painful or uncomfortable physical sensations arise during
intercourse cease the activity. Apply more lubricant or change positions if
needed. If this does not alleviate the discomfort then stop use of the
epithesis immediately to prevent injury.
4. Do not use the epithesis while you or your partner are under the influence
of alcohol or drugs that may impair judgement or alter skin sensations or
awareness.
5. Do not fall asleep while wearing the epithesis, since prolonged inactivity
while wearing the epithesis may cause permanent injury to the phallus.
6. Use of the eptithesis does not prevent transmittion of sexually
transmissible diseases. Always wear a condom over the phallus and epithesis in
order to prevent this.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method