A Study on the Safety and Effectiveness of Subcutaneous Silicone Penile Implant Surgery (NCT04985123) | Clinical Trial Compass
CompletedNot Applicable
A Study on the Safety and Effectiveness of Subcutaneous Silicone Penile Implant Surgery
United States40 participantsStarted 2021-07-30
Plain-language summary
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)
Who can participate
Age range
18 Years – 65 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Adverse Events as Assessed by Observation
Timeframe: 8 weeks
2
Incidence of Adverse Events as Assessed by Observation