Micropenis
Conditions
Brief summary
Injectable filler will be performed by Principal Investigator under sterile conditions for the enhancement of girth and surface area of the penis.
Detailed description
This prospective, single-arm, single-center study was conducted to evaluate the efficacy and safety of injectable dermal fillers for penile enhancement. Prior to enrollment, each participant underwent a comprehensive consultation and provided written informed consent after receiving detailed information regarding the study objectives, procedures, potential risks, benefits, and available alternatives. Following baseline evaluation (Day 1), including standardized photographic documentation and penile measurements, the procedure was performed under sterile conditions in an office-based setting by the Principal Investigator. Topical anesthesia was applied for approximately 10 minutes, after which participants were placed in supine position. A dorsal penile nerve block was administered using local anesthesia, followed by injections of study filler. Participants returned approximately two weeks after the initial treatment for an additional treatment session, when clinically indicated to achieve the planned treatment goal. Follow-up evaluations were conducted at 2, 6, 12 weeks, and at 1year after treatment. The primary efficacy endpoint was change in penile shaft girth from baseline. Safety assessments included systemic monitoring and documentation of treatment-related adverse events throughout the study period. The study was conducted in accordance with the principles of the International Council for Harmonization Good Clinical Practice (ICH GCP) guidelines and was reviewed and overseen by the Institutional Review Board (IRB), Advarra.
Interventions
DEVICEHyaluronic Acid
Injectable
Sponsors
Shafer Clinic Fifth Avenue
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
21 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy males, * 21 to 65 years of age, * Seeking enhancement of their penile width and girth.
Exclusion criteria
* Patient with a history of psychological or psychiatric illness, * Congenital or acquired penile malformation, * Previous plastic surgery or non-invasive treatments of their penis, * Any chronic disease such as vascular disorder, urological disorder, myocardial infarction, hypertension, cerebrovascular accident or coagulopathy. * Patients with a history of allergic reactions to hyaluronic acid derivatives * Individuals with penises measured less than 6 cm in length in the flaccid position * Individuals with penises greater than 12.5 cm in length in the flaccid position. * Individuals with uncircumcised penises
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Penile Shaft Girth at 1 Year | Baseline and 1-year post-treatment follow-up | Penile Shaft Girth was measured in centimeters at baseline and at the1-year post-treatment follow-up. Change from baseline was calculated as the penile shaft girth at the 1-year follow-up minus the penile shaft girth at baseline. Positive values indicate an increase in penile shaft girth, and negative values indicate a decrease. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORDavid Shafer, MD
Shafer Clinic Fifth Avenue
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Penile girth measurements obtained at baseline (Day 1). | 11.10 Centimeters STANDARD_DEVIATION 1.07 |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 6 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
None listed