Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants

Recruiting

• Conditions: Testicular Torsion; Undescended Testes; Orchitis; Testicular Agenesis; Testicular Cancer; Gender Dysphoria; Testicular Atrophy; Prosthesis Durability
• Interventions: Device: Placement of testicular prosthesis

• Registration Number: NCT05097820
• Lead Sponsor: University Hospital, Ghent

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

Study Timeline

• Study Start: 2021-02-05
• Study First Submitted: 2021-09-21
• Study First Submitted QC: 2021-10-15
• Study First Posted: 2021-10-28
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-27
• Last Update Posted: 2023-12-28
• Primary Completion: 2030-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Transgender patients	Placement of testicular prosthesis	All transgender patients in which one or two testicular prostheses are to be implanted for gender reassignment surgery.
Cisgender patients	Placement of testicular prosthesis	All cisgender patients in which one or two testicular prostheses are to be implanted for various reasons.

Primary Outcome Measures

Name	Time	Method
Short term complication rate	Within 90 days postoperatively	Cathegorized according to Clavien-Dindo Classification
Long term complication rate	At 2 years of follow-up	Desciption of overall complications related to testicular prosthesis placement.

Secondary Outcome Measures

Name	Time	Method
Body image of scrotum	Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up	Assessed with non-validated likert scale quationnaires
Change in self-esteem scoring	Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up	Assessed by the Rosenberg Self-Esteem Scale (strongly disagree - strongly agree)
Satisfaction with prosthesis	Baseline questionnaire, followed by reassessment at 3, 6, 12 and 24 months of follow-up	Assessed with non-validated likert scale quationnaires

Trial Locations

Locations (1)

University Hospital Ghent; 🇧🇪 Ghent, East-Flanders, Belgium