Penile Implant
Conditions
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.
Interventions
PROCEDURESilicone Block
Sponsors
International Medical Devices, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Self-Esteem Score | 7 days pre-surgery to 90 days post-surgery | Evaluation of a self-esteem score done pre-surgery and 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 |
| 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 |
Countries
United States
Outcome results
None listed