Efficacy and Stability of Autologous Fat Grafting for Penile Girth Augmentation

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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.

Первичные конечные точки

• Change in Flaccid Penile Mid-Shaft Circumference [Срок оценки: Baseline and 6 weeks post-operatively]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07547839 · Fat Graft for Penile Girth

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗