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

Completed

• Conditions: Penile Implant
• Interventions: Procedure: Silicone Block

• Registration Number: NCT02477189
• Lead Sponsor: International Medical Devices, Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Primary Completion: 2015-05
• Study Completion: 2015-05
• Study First Submitted: 2015-05-15
• Status Verified: 2015-06
• Study First Submitted QC: 2015-06-19
• Last Update Submitted: 2015-06-19
• Study First Posted: 2015-06-22
• Last Update Posted: 2015-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 400

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Study Group	Silicone Block	This was the group that received the penis implant, consented for participation and completed the follow-up questionnaire.

Primary Outcome Measures

Name	Time	Method
Number of Adverse Events	Up to 4 years, with an average of 2 years	Number of adverse events that occurred from implantation through the time of the study.

Secondary Outcome Measures

Name	Time	Method
Self-Esteem Score	7 days pre-surgery to 90 days post-surgery	Evaluation of a self-esteem score done pre-surgery and post-surgery
Quality of Life Questionnaire	7 days pre-surgery to 90 days post-surgery	Measurement of issues with penis size from pre-surgery to post-surgery
Self-confidence score	7 days pre-surgery to 90 days post-surgery	Evaluation of a self-confidence score done pre-surgery and post-surgery
Flaccid penile girth	7 days pre-surgery to 90 days post-surgery	Measurement of flaccid penile girth done pre-surgery and post-surgery

Trial Locations

Locations (1)

Allen Kamrava, MD, MBA; 🇺🇸 Beverly Hills, California, United States