Efficacy and Stability of Autologous Fat Grafting for Penile Girth Augmentation

April 17, 2026 updated by: Mohamed Assem Hussein, Assiut University

Efficacy and Stability of Autologous Fat Grafting for Penile Girth Augmentation: Clinical and Radiologic Follow-up

The primary aim of this study is to evaluate the clinical and radiological efficacy and long-term stability of autologous fat grafting as a method for girth augmentation. The procedure involves extracting approximately 40-80 mL of fat from the patient's lower abdomen. This harvested fat is repeatedly washed , and then injected into the penile dartos layer to enhance penile circumference.

The study will enroll male individuals between 21-60 years old who have regular coital activity, are dissatisfied with their penile girth, and have a flaccid mid-shaft penile circumference of less than 11 cm.

Researchers will measure the clinical success of the procedure by tracking the mean change in penile mid-shaft circumference. Additionally, high-resolution ultrasonography will be used at 6 weeks post-operatively to objectively assess the survival and thickness of the transplanted fat layer. Finally, at a three-month follow-up, patient satisfaction will be evaluated to measure improvements in aesthetic outcomes and functional satisfaction.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Penile girth enhancement using autologous fat injection enhances penile circumference by transferring adipose tissue into the penile dartos layer. Because it utilizes the patient's own living tissue, autologous fat grafting has emerged as a preferred augmentation technique, it provides a natural, soft aesthetic while carrying a superior safety profile with no risk of foreign body rejection or allergic reaction.

A critical component of this trial is the integration of high-resolution ultrasonography (US) to objectively evaluate the survival and distribution of the grafted fat. While standard clinical tape measurements provide a general assessment of circumference, they often lack the precision required to distinguish actual fat graft retention from post-operative edema or inflammatory changes. Serial US evaluations allow researchers to quantify the exact distance between the skin and Buck's fascia, providing a standardized metric to track the rate of fat resorption over time. Furthermore, this radiologic approach enables the early detection of post-operative sequelae, such as fat necrosis, fibrotic nodules, or oil cysts, which may not be palpable during a physical examination.

Procedural Methodology

  • Harvesting: Following the instillation of a tumescent physiological solution, approximately 40-80 mL of fat is harvested from the patient's lower abdomen using a multiperforated cannula.
  • Refinement: The extracted fat is repeatedly washed with sterile saline to remove blood and debris. To ensure smooth injection, it undergoes mechanical refinement via luer-to-luer connectors to progressively reduce the globule size.
  • Transfer: The purified fat is transferred to 3-mL syringes and injected into the subdartos space across four quadrants using a blunt 18-gauge cannula to ensure placement just above the tunica albuginea. The fat is deposited in vertical lines utilizing a retrograde injection technique.
  • Recovery: Patients are instructed to abstain from intercourse for 4 weeks post-procedure to allow for initial graft stabilization.

Study Type

Interventional

Enrollment (Estimated)

25

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Male individuals dissatisfied with their penile girth
  • Mid-shaft penile circumference at flaccid state less than 11 cm
  • Regular coital activity
  • Age between 21-60 years old

Exclusion Criteria:

  • Mid-shaft penile circumference at flaccid state more than 11 cm
  • Congenital penile deformities
  • Previous penile augmentation
  • Inflammatory skin infection (balanitis)
  • Blood disorder such as hemophilia, leukemia, or lymphoma
  • Psychiatric disorder such as body dysmorphic disorder, bipolar disorder, obsessive compulsive disorder (OCD), or depression

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Autologous Fat Grafting
Participants in this arm will undergo penile girth enhancement via autologous fat grafting. Approximately 40-80 mL of fat will be harvested from the patient's lower abdomen using a multiperforated cannula. The fat is then purified with physiological saline and mechanically refined to reduce globule size. Finally, the prepared fat is injected into the penile subdartos space across four quadrants using a blunt 18-gauge cannula to ensure uniform distribution.
Procedure: Autologous Fat Grafting
Approximately 40-80 mL of body fat is harvested from the patient's lower abdomen using a multiperforated cannula. The harvested fat is repeatedly washed with sterile physiological saline to remove blood and debris, then undergoes mechanical refinement to reduce globule size. Finally, the refined fat is transferred to 3-mL syringes and injected into the four quadrants of the penile dartos layer (just above the tunica albuginea) using a blunt 18-gauge cannula.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Flaccid Penile Mid-Shaft Circumference
Time Frame: Baseline and 6 weeks post-operatively
Measurement of the change in penile mid-shaft circumference, assessed in centimeters (cm) using a clinical tape measure. The measurement is taken in the flaccid state to evaluate the clinical efficacy of the girth augmentation by comparing post-operative dimensions to the pre-operative baseline.
Baseline and 6 weeks post-operatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2026

Primary Completion (Estimated)

May 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

April 17, 2026

First Submitted That Met QC Criteria

April 17, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 17, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Fat Graft for Penile Girth

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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