Efficacy and Stability of Autologous Fat Grafting for Penile Girth Augmentation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age21-60
SponsorAssiut University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Mid-shaft penile circumference at flaccid state more than 11 cm
Congenital penile deformities
Previous penile augmentation
Inflammatory skin infection (balanitis)
Trial design
Design model
Single group
Treatments tested in this trial
Autologous Fat Grafting
Procedure/SurgeryApproximately 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.
Treatment groups
25 Participants
are divided into 1 treatment groupGroup A: Autologous Fat GraftingExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
Baseline and 6 weeks post-operativelyLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: