A Study on the Safety and Effectiveness of Subcutaneous Silicone Penile Implant Surgery
NCT ID: NCT04985123
Last Updated: 2022-04-06
Study Results
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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UNKNOWN
40 participants
OBSERVATIONAL
2021-07-30
2023-05-25
Brief Summary
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The plan is to conduct a study to examine the outcomes of this procedure with respect to:
* Incidences of adverse events
* Changes in flaccid penile length (through physical measurements pre and post-operatively in a consistent manner)
* Changes in flaccid penile girth (through physical measurements pre and post-operatively in a consistent manner)
* Changes in satisfaction scores with respect to penile size and patient self-confidence/self-esteem (through validated questionnaires)
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Silicone Block patients
All subjects who received a successful penile implantation with the Silicone Block by the surgeons at the centers in this study.
Pre-Formed Penile Silicone Block Implant
Implantation of Pre-Formed Penile Silicone Block Implant
Interventions
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Pre-Formed Penile Silicone Block Implant
Implantation of Pre-Formed Penile Silicone Block Implant
Eligibility Criteria
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Inclusion Criteria
* A loss of length following radical prostatectomy or other trauma
* Congenital or acquired (e.g., Peyronie's Disease) mild curvature of the penis with indentation deformity and with curvature less than 30 degrees with no plan to have other corrective procedures (e.g. surgery, intralesional injection of collagenase clostridium histolyticum)
* Patient perception of a penis of inadequate size and patient desire for cosmetic enhancement
Exclusion Criteria
* An uncircumcised penis
* Micro-penis (stretched flaccid penile length \<6cm)
* Prior penile girth enhancement procedure of any sort, including grafts or subcutaneous injections, previous Xiaflex injection
* History of immunosuppression and/or HIV
* Men who are on anti-coagulation medication which cannot be stopped
* Uncontrolled diabetes
* Active genitourinary skin infection
* History of recurrent or active urinary tract infection (UTI)
* Patients unwilling to comply with post-operative instructions
* Patients who smoke and are unwilling to stop 2 weeks before surgery and for at least 6 weeks after surgery.
18 Years
65 Years
MALE
Yes
Sponsors
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International Medical Devices, Inc.
INDUSTRY
Responsible Party
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Locations
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Uropartners
Chicago, Illinois, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Pro00036006
Identifier Type: -
Identifier Source: org_study_id
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