A Proof of Concept Top Evaluate a Novel Penile Lengthening Protocol

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.

Study Overview

• Status: Unknown
• Conditions: Penile Elongation
• Intervention / Treatment: Combination product: Platelet-rich plasma

• Study Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

• Study Contact: Name: Judson Brandeis, MD; Phone Number: 510-587-3000; Email: Judson@BrandeisMD.com

Study Locations

• United States
  • California
    • San Ramon, California, United States, 94583
      • Recruiting
      • BrandeisMD
      • Contact: Judson Brandeis, MD; Phone Number: 510-587-3000; Email: Judson@BrandeisMD.com
      • Sub-Investigator: Scott Lu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 53 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Study participants comprised of men with a desire for penile elongation.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Treatment Group; Monthly intracavernosal platelet-rich plasma injection + daily physical manipulation.	Combination product: Platelet-rich plasma; 12mL of platelet-rich plasma injected into cavernosal bodies bilaterally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stretched penile length	Change in length of stretched, flaccid penile length	baseline to six months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Judson Brandeis
• Investigators: Principal Investigator: Judson Brandeis, MD, BrandeisMD

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2019
• Primary Completion (Anticipated): May 12, 2021
• Study Completion (Anticipated): July 12, 2021

Study Registration Dates

• First Submitted: January 14, 2020
• First Submitted That Met QC Criteria: January 14, 2020
• First Posted (Actual): January 18, 2020

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: platelet-rich plasma
• Other Study ID Numbers: BRAND-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No