Trial Outcomes & Findings for Shafer Width and Girth: The Use of Injectable Fillers for Penile Enhancement (NCT NCT04755634)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

20 participants

Primary outcome timeframe

Baseline and 1-year post-treatment follow-up

Results posted on

2026-08-18

Participant Flow

Participant milestones

Participant milestones
Measure	Prospective, Single-Arm, Single-Center Study This is a prospective, single-arm, single-center study, in which all participants received injectable dermal filler for penile enhancement.
Overall Study STARTED	20
Overall Study COMPLETED	17
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Prospective, Single-Arm, Single-Center Study n=20 Participants This is a prospective, single-arm, single-center study, in which all participants received injectable dermal filler treatment for penile enhancement.
Age, Categorical <=18 years	0 Participants n=20 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=20 Participants
Age, Categorical >=65 years	0 Participants n=20 Participants
Sex: Female, Male Female	0 Participants n=20 Participants
Sex: Female, Male Male	20 Participants n=20 Participants
Penile girth measurements obtained at baseline (Day 1).	11.10 Centimeters STANDARD_DEVIATION 1.07 • n=20 Participants

PRIMARY outcome

Timeframe: Baseline and 1-year post-treatment follow-up

Population: Participants with both baseline and 1-year penile girth measurements were included in the analysis.

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.

Outcome measures

Outcome measures
Measure	Single Arm n=17 Participants This was a prospective, single-arm, single-center study in which all participants received injectable dermal filler treatment for penile enhancement.
Change From Baseline in Penile Shaft Girth at 1 Year	2.83 Centimeters Standard Deviation 0.16

Adverse Events

Protocol Section: This is Prospective, Single Arm, Single Center Study.

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Protocol Section: This is Prospective, Single Arm, Single Center Study. n=20 participants at risk Study participants were evaluated for adverse events at 2, 6, and 12 weeks and at the 1-year post-treatment follow-up. No all-cause mortality or serious adverse events occurred during the study. Only non-serious adverse events are presented in this section.
Reproductive system and breast disorders Decreased sensation	5.0% 1/20 • 1 Year
Reproductive system and breast disorders Increased time to ejaculate	5.0% 1/20 • 1 Year
Reproductive system and breast disorders Texture irregularity	10.0% 2/20 • 1 Year
Reproductive system and breast disorders Contour deformity	15.0% 3/20 • 1 Year

Additional Information

Director Clinical Studies

Shafer Clinic Fifth Avenue

Phone: 201 280 2127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place