A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol

• Conditions: Penile Elongation
• Interventions: Combination Product: Platelet-rich plasma

• Registration Number: NCT04231422
• Lead Sponsor: Judson Brandeis

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-11-12
• Status Verified: 2020-01
• Study First Submitted: 2020-01-14
• Study First Submitted QC: 2020-01-14
• Last Update Submitted: 2020-01-14
• Study First Posted: 2020-01-18
• Last Update Posted: 2020-01-18
• Primary Completion: 2021-05-12
• Study Completion: 2021-07-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Treatment Group	Platelet-rich plasma	Monthly intracavernosal platelet-rich plasma injection + daily physical manipulation.

Primary Outcome Measures

Name	Time	Method
Stretched penile length	baseline to six months	Change in length of stretched, flaccid penile length

Secondary Outcome Measures

Name	Time	Method
SHIM Score	baseline to six months	Change in erectile function
Safety Measurement	baseline to six months	Incidence of adverse events and serious adverse events
BDD-YBOCS	baseline to six months	Change in body dysmorphia scale

Trial Locations

Locations (1)

BrandeisMD; 🇺🇸 San Ramon, California, United States