Shafer Width and Girth: The Use of Injectable Fillers for Penile Enhancement

Shafer Clinic Fifth Avenue20 enrolled

Overview

Injectable filler will be performed by Principal Investigator under sterile conditions for the enhancement of girth and surface area of the penis.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Micropenis

Interventions

Hyaluronic AcidDEVICE

Injectable

Eligibility

Sex: MALEMin age: 21 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Shafer Clinic Fifth Avenue

New York, New York, United States

Outcomes

Primary Outcomes

Change From Baseline in Penile Shaft Girth at 1 Year

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.

Time frame: Baseline and 1-year post-treatment follow-up

Data from ClinicalTrials.gov

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