Actively Recruiting
Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients
Led by University Hospital, Ghent · Updated on 2024-08-05
40
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University Hospital, Ghent
Lead Sponsor
E
ELATOR/EREKTOR
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research explores options for transgender and gender diverse individuals who have undergone phalloplasty, a surgery to create masculine external genitalia. The study compares the use of an internal erectile prosthesis, which is currently the main method to achieve penile rigidity but has high complication rates, with external devices called epitheses, which may offer an alternative without surgery. The goal is to better understand the usability, satisfaction, and complications of these options in this population. Participants will receive either an Elator device, an external penile lifter measured to fit their phallus, or a Zephyr ZSI 475 FTM internal erection prosthesis, which is the current standard of care. The prosthesis group will follow a healing phase of at least six weeks. Both groups will use their assigned device over four months while completing questionnaires about sexual activity, quality of relationship, satisfaction, and usability. Researchers will monitor complications and other health outcomes throughout the study. During the study, participants and their partners will answer questionnaires at baseline and at various points over four months regarding sexual function, satisfaction, relationship quality, and urinary symptoms. Researchers will also assess physical parameters and track complications within 90 days after surgery or device use. The study aims to measure the percentage of patients choosing each device and the ability to perform penetrative intercourse, with ongoing monitoring of safety and quality of life over the study period.
CONDITIONS
Brief Title
Epithesis Versus Prosthesis in Post-phalloplasty Transgender Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Transgender or gender non-conforming individuals diagnosed with gender dysphoria by DSM-5 criteria
- Patients who have undergone phalloplasty at Ghent University Hospital or Amsterdam UMC
- At least 1 year has passed since phalloplasty surgery
- At least 3 months after coronaplasty with a reasonably pronounced coronal ridge (required only for epithesis group)
- Anatomic penile length and girth as determined by surgeons
- No urethral stricture or structural voiding problems
- Normal uroflowmetry and post-void residual urine
- Protective sensation regained at tip of phallus
- Established primary sexual relationship with partner willing to participate
- Both patient and partner interested in penetrative sexual intercourse
- Patient unable to penetrate partner adequately without supportive measures
- Fit and eligible for erectile prosthesis surgery per surgeon's opinion
- No history of erectile prosthesis surgery
- No fear or disinterest in prosthesis surgery (required only for epithesis group)
- No prior use of ElatorTM or ErektorTM epithesis
- Voluntary written informed consent according to regulations
You will not qualify if you...
- Cisgender patients treated with phalloplasty
- Patients who had metoidioplasty only (except if followed by phalloplasty)
- Absence of coronaplasty or coronaplasty less than 3 months ago or insufficient coronal ridge (only for epithesis group)
- Penile dimensions not anatomic (too small or too large)
- Underlying lower urinary tract disorders needing treatment
- Inadequate protective sensation in the penis
- No established sexual partner or partner unwilling to participate
- Patient and/or partner not interested in penetrative sexual intercourse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 months
Participants receive either an internal penile prosthesis or an external epithesis device to assist with penetrative sexual intercourse after phalloplasty. The prosthesis group undergoes surgery with a healing phase of at least six weeks, while the epithesis group uses a device fitted to their phallus. Both groups use their assigned device during sexual activity and provide feedback through questionnaires.
Monthly visits for questionnaires and assessments
Trial Site Locations
Total: 2 locations
1
Department of Urology, University Hospital Ghent
Ghent, East-Flanders, Belgium, 9000
Actively Recruiting
2
Department of Urology, Amsterdam University Medical Center
Amsterdam, North Holland, Netherlands, 1081
Not Yet Recruiting
Research Team
N
Nicolaas Lumen, MD, PhD
W
Wietse Claeys, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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