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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

400 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Penile Implant

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Study Group

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

Silicone Block

Intervention Type PROCEDURE

Interventions

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Silicone Block

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No