Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0-110
SponsorUniversity Hospital, Ghent

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Placement of testicular prosthesis

    Device

    The surgical implantation of one or two testicular prostheses on request of the patient

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Cisgender patients1 intervention
Group B: Transgender patients1 intervention

Trial outcomes

Primary outcomes

1

Short term complication rate

Cathegorized according to Clavien-Dindo Classification

Time frame
Within 90 days postoperatively
2

Long term complication rate

Desciption of overall complications related to testicular prosthesis placement.

Time frame
At 2 years of follow-up

Secondary outcomes

1

Change in self-esteem scoring

Assessed by the Rosenberg Self-Esteem Scale (strongly disagree - strongly agree)

Time frame
Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
2

Body image of scrotum

Assessed with non-validated likert scale quationnaires

Time frame
Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
3

Satisfaction with prosthesis

Assessed with non-validated likert scale quationnaires

Time frame
Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up

Other outcomes

Sponsors and contacts

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