Efficacy and Stability of Autologous Fat Grafting for Penile Girth Augmentation

NCT07547839 | Not Yet Recruiting

• 1 other identifier: Fat Graft for Penile Girth
• Study Type: interventional
• Target: 25
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Penile Girth Augmentation; Fat Graft

Keywords

Penile Girth Augmentation; Autologous Fat Grafting; Fat Transfer; Penile Enhancement; Ultrasonography

Outcome Measures

Primary Outcomes (1)

• Change in Flaccid Penile Mid-Shaft Circumference

  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

Study Arms (1)

Autologous Fat Grafting

EXPERIMENTAL

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

Interventions

Autologous Fat Grafting PROCEDURE

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.

Autologous Fat Grafting

Eligibility Criteria

• Age: 21 Years - 60 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident at Andrology Department, Assiut University

Study Record Dates

• First Submitted: April 17, 2026
• First Posted: April 23, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04