About this trial
To analyze the short and long term postoperative clinical outcome and patient satisfaction of silicone gel-filled testicular implants.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The patient is an adult or a child at the time of testicular implant placement.
The patient is a candidate to unilateral or bilateral testicular implant placement.
The patient has been informed of the study, has read the patient information letter and provided oral and written consent.
If the patient is of French nationality, he/she must be affiliated to the French Social Security.
Disqualifiers
The patient has silicone implants somewhere else than in the scrotal sac (except for a penile prosthesis).
Trial population
Any undividual with an underlying reason for testicular loss with a specific wish for testicular implant placement. Any patient with the underlying condidion of gender dysphoria with the specific wish for testicular implant placement as a form of gender reassignment surgery.
Trial design
Cohort
Prospective
Treatments tested in this trial
Placement of testicular prosthesis
DeviceThe surgical implantation of one or two testicular prostheses on request of the patient
Treatment groups
Trial outcomes
Primary outcomes
Short term complication rate
Cathegorized according to Clavien-Dindo Classification
Long term complication rate
Desciption of overall complications related to testicular prosthesis placement.
Secondary outcomes
Change in self-esteem scoring
Assessed by the Rosenberg Self-Esteem Scale (strongly disagree - strongly agree)
Body image of scrotum
Assessed with non-validated likert scale quationnaires
Satisfaction with prosthesis
Assessed with non-validated likert scale quationnaires
Sponsors and contacts
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University Hospital, Ghent
Lead sponsor
Groupe SEBBIN
Collaborator