Shafer Width and Girth: The Use of Injectable Fillers for Penile Enhancement
Study Overview
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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New York
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New York, New York, United States, 10017
- Shafer Clinic Fifth Avenue
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: Single Arm
This is a prospective, single-arm, single-center study
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Injectable
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change From Baseline in Penile Shaft Girth at 1 Year
Time Frame: 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.
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Baseline and 1-year post-treatment follow-up
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Duration of increase in penile width and girth
Time Frame: 1 year
|
For how long duration the treatment will produce a measurable difference in penile size.
|
1 year
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: David Shafer, MD, Shafer Clinic Fifth Avenue
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00034295
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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