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OpenTrials
Completed

NCT Number: NCT04985123

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)

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

Male

Study type

Observational

Primary location

Uropartners

Chicago, Illinois, 60612, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Pre-Formed Penile Silicone Block Implant

Device

Implantation of Pre-Formed Penile Silicone Block Implant

Primary outcomes

  1. Incidence of Adverse Events as Assessed by Observation

    Time frame: 8 weeks

  2. Incidence of Adverse Events as Assessed by Observation

    Time frame: 3 months

Secondary outcomes

  1. Size of Flaccid Penile Girth as Measured by Physicians

    Time frame: 8 weeks

  2. Size of Flaccid Penile Girth as Measured by Physicians

    Time frame: 3 months

  3. Patient Reported Satisfaction as Assessed by Validated Questionnaires

    Time frame: 8 weeks

  4. Patient Reported Satisfaction as Assessed by Validated Questionnaires

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

International Medical Devices, Inc.

Industry

Registry information

Important dates

Study start
2021
Primary completion
2024
Study completion
2025
First posted
Aug 2, 2021
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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