Efficacy and Stability of Autologous Fat Grafting for Penile Girth Augmentation: Clinical and Radiologic Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 25
- 主要终点
- Change in Flaccid Penile Mid-Shaft Circumference
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Autologous Fat Grafting (Procedure)
结局指标
主要结局
Change in Flaccid Penile Mid-Shaft Circumference
时间窗: 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.
次要结局
未报告次要终点
研究者
Mohamed Assem Hussein
Resident at Andrology Department, Assiut University
Assiut University