Clinical trial NCT05097820: Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants
Official title: Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Testicular Cancer
Testicular Torsion
Gender Dysphoria
Undescended Testes
Orchitis
Testicular Agenesis
Testicular Atrophy
Prosthesis Durability
Keywords: testicular prosthesis
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: Groupe SEBBIN
First posted: 2021-10-28
Enrollment: 100
Sex: ALL
Minimum age (years): 0
Maximum age (years): 110
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study 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.

Brief summary: To analyze the short and long term postoperative clinical outcome and patient satisfaction of silicone gel-filled testicular implants.

Detailed description: Testicular implants made from various materials have been in use since 1941. The lack of a testicle has proven to be a psychologically traumatic experience for men of all ages. Therefore, testicular implants are placed in the scrotum for various reasons on request of the patient.The intended target population for the silicone gel-filled testicular implants of Groupe SEBBIN is any patient (children or adults) with agenesis or testicular atrophy, undescended testicle, testicular tumour, epididymitis / orchitis, or a trauma, for whom an orchidectomy with placement of a testicular prosthesis is indicated. Testicular implants are also indicated for sex reassignment surgeries.

The main complications after testicular implant placement recorded in the literature include extrusion, scrotal contraction, pain, hematoma, and infection. The literature about testicular implant is sparse, and no report on the use of SEBBIN silicone gel-filled testicular implants have been identified in the scientific literature.

The Gel-filled Testicular Implant medical devices are manufactured by GROUPE SEBBIN under the brand name 'Laboratoires SEBBIN'. The Gel-filled Testicular Implant medical devices are presented sterile (Ethylene oxide sterilization) and are double wrapped for single use.

The medical grade raw materials used for the manufacturing of these prostheses are bio-compatible and completely traceable. The substances belong to the polydimethylsiloxane family.

This study is part of the clinical evaluation of SEBBIN silicone gel-filled testicular implants, included in the technical file of the device. The aim of the study is to gather data on the safety and effectiveness of the device. For this purpose, the overall short and long term complication rate and complication grade. Secondly, the investigators evaluate patient satisfaction and quality of life by use of questionnaires

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* The patient has silicone implants somewhere else than in the scrotal sac (except for a penile prosthesis).
* The patient was diagnosed with one of the following pathologies:

Systemic lupus erythematous, Sjogren syndrome, scleroderma, polymyositis, or any other connective tissue disease.

Rheumatoid arthritis, crystalline arthritis, infectious arthritis, spondyloarthropathies, or any other inflammatory arthritic disease.

Arthritis, fibromyalgia, chronic fatigue syndrome, or any other mechanic or degenerative non-inflammatory rheumatic disease.

The patient has any other underlying condition that could delay healing.

- Custom-designed implants are used for surgery.

Primary outcomes:
measure: Short term complication rate
timeFrame: Within 90 days postoperatively
measure: Long term complication rate
timeFrame: At 2 years of follow-up
Secondary outcomes:
measure: Change in self-esteem scoring
timeFrame: Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
measure: Body image of scrotum
timeFrame: Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
measure: Satisfaction with prosthesis
timeFrame: Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: University Hospital Ghent
state: East-Flanders
Study officials:
affiliation: University Hospital, Ghent
name: Anne-Françoise Spinoit, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: