Prospective Observational Study on SEBBIN Silicone Gel-filled Testicular Implants

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

Study Overview

• Status: Recruiting
• Conditions: Gender Dysphoria; Orchitis; Testicular Cancer; Prosthesis Durability; Testicular Torsion; Undescended Testes; Testicular Agenesis; Testicular Atrophy
• Intervention / Treatment: Device: Placement of testicular prosthesis

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 Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Anne-Françoise Spinoit, MD, PhD; Phone Number: 003293322276; Email: anne-francoise.spinoit@uzgent.be
• Study Contact Backup: Name: Wietse Claeys, MD; Phone Number: 003293322276; Email: wietse.claeys@uzgent.be

Study Locations

• Belgium
  • East-Flanders
    • Ghent, East-Flanders, Belgium, 9000
      • Recruiting
      • University Hospital Ghent
      • Contact: Anne-Françoise Spinoit, MD, PhD; Phone Number: 003293322276; Email: anne-francoise.spinoit@uzgent.be
      • Contact: Wietse Claeys, MD, PhD; Phone Number: 003293321702; Email: wietse.claeys@uzgent.be
      • Principal Investigator: Anne-Françoise Spinoit, MD, PhD
      • Sub-Investigator: Wietse Claeys, MD
      • Sub-Investigator: Celine Sinatti, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 110 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Cisgender patients; All cisgender patients in which one or two testicular prostheses are to be implanted for various reasons.	Device: Placement of testicular prosthesis; The surgical implantation of one or two testicular prostheses on request of the patient
Transgender patients; All transgender patients in which one or two testicular prostheses are to be implanted for gender reassignment surgery.	Device: Placement of testicular prosthesis; The surgical implantation of one or two testicular prostheses on request of the patient

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Groupe SEBBIN
• Investigators: Principal Investigator: Anne-Françoise Spinoit, MD, PhD, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2021
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030

Study Registration Dates

• First Submitted: September 21, 2021
• First Submitted That Met QC Criteria: October 15, 2021
• First Posted (Actual): October 28, 2021

Study Record Updates

• Last Update Posted (Actual): December 28, 2023
• Last Update Submitted That Met QC Criteria: December 27, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: testicular prosthesis
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Postoperative Complications; Endocrine System Diseases; Gonadal Disorders; Urogenital Abnormalities; Congenital Abnormalities; Endocrine Gland Neoplasms; Genital Neoplasms, Male; Testicular Diseases; Sexual Dysfunctions, Psychological; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Testicular Neoplasms; Gender Dysphoria; Orchitis; Prosthesis Failure; Spermatic Cord Torsion; Cryptorchidism
• Other Study ID Numbers: BC-8299

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: After publication of findings, the individual patient data can be provided upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No