Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity Hospital, Ghent
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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).
Disqualifiers
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).
Trial design
Design model
Parallel
Treatments tested in this trial
Usability and added value of device within sexual activity
DeviceParticipants and there partners will be asked to use the device over the course of 4 months, during which both will provide answers to questionnaires on quality of relation and sexual life, and detailed questions on the usability and the added value of the used device during sexual activity along with overall satisfaction with the device.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Epithesis groupExperimental treatment 1 intervention
Group B: Prosthesis groupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Percentage of patients choosing either for the prosthesis or the epithesis at the start of study
At baseline, patients will get information on both the prosthesis and the epithesis and will be free to choose between them. This difference in percentage and the reasons for choosing between either will be noted.
Time frame
Baseline assessment2
Difference in capability rate of vaginal and/or anal penetration of the participant's partner
* Capability will be defined as full repetitive anal and/or vaginal penetration of the partner while using the epithesis or prosthesis, which was not possible before use or implantation, without pain to patient and/or partner, until the end of the intended sexual intercourse. * If penetration is not possible, the reasons for this incapacity will be noted
Time frame
Baseline questionnaire, followed by reassessment at 1 and 4 months after study startSecondary outcomes
1
Interest in continued use of epithesis by both patient and partner
Interest in continued use will be defined as the proportion of patients and their partners in the epithesis arm with interest in and willingness to continue use of the external penile epithesis after the study period.
Time frame
Assessment at 4 months after study start2
Difference in quality of sexual experience
Assessed using the Quality of Sexual Experience questionnaire (QSE). The QSE questionnaire provides a summative score between 7 and 49. A higher score indicates a better sexual experience.
Time frame
Baseline questionnaire, followed by reassessment shortly after sexual activity. To be filled out by patient and partner at least once per month during the 4 months of the study period3
Difference in treatment satisfaction
Assessed using the Erectile Dysfunction Inventory of Treatment Satisfaction questionnaire (EDITS). The EDITS questionnaire provides two summative scores of 0-44 and 0-20 for patient and partner scores respectively. A higher score indicates a better treatment satisfaction. Higher scores indicate better outcome.
Time frame
Assessment at 1 and 4 months after study start4
Difference in relationship satisfaction
Assessed using the Maudsley Marital Questionnaire (MMQ). The MMQ provides three summative scores of 0-80, 0-40 and 0-40 on relationship satisfaction, sexual satisfaction, and overall quality of life respectively. Lower scores indicate better outcome.
Time frame
Baseline questionnaire, followed by reassessment at 1 and 4 months after study startSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Hospital, Ghent
Lead sponsor
ELATOR/EREKTOR
Collaborator
Source ClinicalTrials.gov