A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol

Judson Brandeis

Status: Unknown

Conditions: Penile Elongation

Treatments: Combination Product: Platelet-rich plasma

Study type: Observational

Funder types: Industry

Identifiers

NCT04231422

BRAND-003

Details and patient eligibility

About

The objective of this study is to examine and quantify the efficacy and safety of a new treatment protocol using platelet-rich plasma for penile length enhancement.

Enrollment: 30 estimated patients

Sex: Male

Ages: 20 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Stretched penile length between 3.5 - 8.0 in
2. Age 20-55 years of age
3. Desire penile length elongation
4. Willing to complete all aspects of combined treatment plan
5. Able to measure erect penile length and mid-shaft girth at 1-month intervals
6. Judged to be in good health based on medical history, physical exam, and laboratory profile
7. Is willing and able to cooperate with the requirement of the study (e.g. completion of all planned study visits)

Exclusion criteria

1. No prior surgical Peyronie's disease treatment
2. No chordee with or without hypospadias
3. No infiltration by benign or malignant mass
4. No active STD
5. No infiltration by an infectious agent such as lymphogranuloma venereum
6. No uncontrolled psychiatric conditions
7. No uncontrolled neurologic conditions
8. No other uncontrolled medical conditions such as HTN or DM
9. No history of spontaneous priapism
10. Is unable to safely use the study devices as determined by the principal investigator
11. No thrombosis of the dorsal penile artery or vein
12. No known history of coagulation disorder
13. No known history of stroke, bleeding, or another significant medical conditional which the investigator deems makes the subject unsuitable for enrollment in the study
14. Testosterone level lower than 500

Trial design

30 participants in 1 patient group

Treatment Group

Description:

Monthly intracavernosal platelet-rich plasma injection + daily physical manipulation.

Treatment:

Combination Product: Platelet-rich plasma