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Clinical Trials/NCT02477189
NCT02477189
Completed
Not Applicable

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

International Medical Devices, Inc.1 site in 1 country400 target enrollmentApril 2015
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ConditionsPenile Implant

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Penile Implant
Sponsor
International Medical Devices, Inc.
Enrollment
400
Locations
1
Primary Endpoint
Number of Adverse Events
Status
Completed
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2015
End Date
May 2015
Last Updated
10 years ago
Study Type
Observational
Sex
Male

Investigators

Sponsor
International Medical Devices, Inc.
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Number of Adverse Events

Time Frame: 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 Outcomes

  • Self-Esteem Score(7 days pre-surgery to 90 days post-surgery)
  • Quality of Life Questionnaire(7 days pre-surgery to 90 days post-surgery)
  • Self-confidence score(7 days pre-surgery to 90 days post-surgery)
  • Flaccid penile girth(7 days pre-surgery to 90 days post-surgery)

Study Sites (1)

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