Efficacy and Stability of Autologous Fat Grafting for Penile Girth Augmentation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Autologous Fat Grafting.
- Who it may be relevant to
- Registry conditions: Penile Girth Augmentation, Fat Graft. Basic parameters: 21 years — 60 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Efficacy and Stability of Autologous Fat Grafting for Penile Girth Augmentation: Clinical and Radiologic Follow-up
Overview
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.
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.
Interventions
- 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.
Primary outcome measures
- Change in Flaccid Penile Mid-Shaft Circumference [Time frame: Baseline and 6 weeks post-operatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07547839 · Fat Graft for Penile Girth