Retrospective Analysis of the Safety and Effectiveness of Using the Silicone Block in Penile Surgery

International Medical Devices, Inc.

Status: Completed

Conditions: Penile Implant

Treatments: Procedure: Silicone Block

Study type: Observational

Funder types: Industry

Identifiers

NCT02477189

IMD-0115

Details and patient eligibility

About

This is a retrospective evaluation of all subjects who successfully received implantation of the Silicone Block for correction of soft tissue deformities of the penis. In addition, subjects will be sent a questionnaire to complete that will evaluate the subject's ongoing satisfaction with the implant and any adverse events that may not have been reported to the physician.

Enrollment: 400 patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Successful penile implantation with the Silicone Block. Successful implantation is defined as the successful completion of the implantation procedure.

Exclusion criteria

• Medical records for the subject are not available for review or tabulation
• Subject did not comply with pre-operative or post-operative instructions.

Trial design

400 participants in 1 patient group

Study Group

Description:

This was the group that received the penis implant, consented for participation and completed the follow-up questionnaire.

Treatment:

Procedure: Silicone Block