A Study on the Safety and Effectiveness of Subcutaneous Silicone Penile Implant Surgery

This study will identify a patient population who wishes to address a variety of concerns about the size, shape, or appearance of their penis with the placement of a subcutaneous Silicone Block Penile Implant. Because the Silicone Block is placed subcutaneously, the device can provide immediate and permanent improvements to the appearance of a man's penis. The most notable improvements are enhanced penile cosmesis, improved penile girth, and improved exposure of the penile shaft outside the plane of the body.

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)

Study Overview

• Status: Completed
• Conditions: Penile Implant
• Intervention / Treatment: Device: Pre-Formed Penile Silicone Block Implant

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60612
      • UroPartners

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

All subjects who received a successful penile implantation with the Silicone Block by the surgeons at the centers in this study.

Description

Inclusion Criteria:

• Inclusion criteria include men who are over 18 and under 65, circumcised, who have the perception of inadequate penile girth or appearance of length of penis, or penile deviation from straight plane in flaccid condition for whatever reason. Etiologies may include:
• A retractile penis or "buried penis" from infrapubic pannus
• 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:

• Men who are unable to give informed consent
• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Silicone Block patients; All subjects who received a successful penile implantation with the Silicone Block by the surgeons at the centers in this study.	Device: Pre-Formed Penile Silicone Block Implant; Implantation of Pre-Formed Penile Silicone Block Implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of Adverse Events as Assessed by Observation	8 weeks
Incidence of Adverse Events as Assessed by Observation	3 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Size of Flaccid Penile Girth as Measured by Physicians	8 weeks
Size of Flaccid Penile Girth as Measured by Physicians	3 months
Patient Reported Satisfaction as Assessed by Validated Questionnaires	8 weeks
Patient Reported Satisfaction as Assessed by Validated Questionnaires	3 months

Collaborators and Investigators

• Sponsor: International Medical Devices, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2021
• Primary Completion (Actual): August 25, 2024
• Study Completion (Actual): April 25, 2025

Study Registration Dates

• First Submitted: July 16, 2021
• First Submitted That Met QC Criteria: July 26, 2021
• First Posted (Actual): August 2, 2021

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 23, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: Pro00036006

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No