SURGE Study

SURGE Study

SURGE Study

The SURGE Study

A Study to evaluate the safety, tolerability and preliminary efficacy of a topical serum (SURGE) for improving blood flow to the penis.

What is the SURGE Study?

The SURGE Study is the most recent research study created by BrandeisMD.  SURGE is a proprietary topical supplement formulation that we are investigating for its use in providing immediate improvement of penile blood flow and enhancement of erection.

Clinical Research at BrandeisMD

BrandeisMD is committed to advancing men’s sexual medicine through research, education, and innovation.  Besides providing exceptional patient care and mentorship to sexual medicine providers around the United States, BrandeisMD is committed to clinical research and the development of new products in the field of sexual medicine for men.  The SURGE Study was selected to be our fifth clinical study at BrandeisMD.  Men who had undergone robotic prostatectomy sometime lose the nerves necessary for the achievement of an erection.  To get an erection, they need to inject a medication directly into the penis.  (Yes, Ouch!)

We have developed a topical supplement to enhance blood flow to the penis for men who can’t achieve an erection because the nerve input to the penis has been compromised.  Other men who would potentially benefit from the SURGE serum are men who have undergone radiation therapy for prostate cancer or have penile implants.  Additionally, SURGE has the potential benefits of rapid onset of action and rapid clearance.

SURGE Study Population

The SURGE study is seeking the following participants 1) 7 young men with no erectile dysfunction or prostate disease; 2) 7 men who were potent prior to surgery who have undergone robotic prostatectomy and; 3) 7 men who were potent prior to treatment have undergone radiation therapy for prostate disease.  These three populations represent groups of men that may benefit from SURGE treatment

Study Procedure

Participants in the SURGE study should expect to make one initial enrollment office visit and then two office visits for ultrasounds.

Visit 1
  • Participants will have a medical history taken as well as a physical exam
  • Patients will be given a lab slip to get a free set of labs (value $1200)
  • Participants will be asked to complete a brief baseline study questionnaire
  • Participants will be instructed on the proper use of SURGE and provided with the medication for daily application
  • Patients will undergo a free baseline aorto-iliac ultrasound (value $300) and then a baseline duplex ultrasound of the penis. This ultrasound will then be sent for additional digital analysis by Morphometix
  • Participants will apply SURGE and wait 5-10 minutes and then will undergo repeat Doppler imaging of their penis
  • Measurements will also be taken, including the time to achievement of an erection and change in length.
Visit 2
  • Participants will undergo penile Doppler Ultrasound prior to application of SURGE
  • Participants will be asked to complete the same questionnaire as the first visit
  • Participant will apply SURGE, wait 5-10 minutes, and then undergo a repeat Doppler US
Safety

Previous research, including research into similar topical formulations for topical erectile enhancement agents, have determined SURGE is a SAFE medication with NO reported side effects.  Potential side effects include local skin reactions or allergic reactions.  Participants should report any possible side effects they experience to study staff via phone (925-255-7867) or email (Research@BrandeisMD.com).

Privacy

Your privacy is of the highest importance to us at BrandeisMD.  Participants will have their data de-identified as the first step of data entry.  This includes responses to study questionnaires, imaging, and other measurements. Additionally, all data collected as part of the SURGE study will be kept on password protected local files at the BrandeisMD offices.

Study Results

Participants will be the first to be informed of our research conclusions.  Participants will additionally be informed, if they desire, of any use of the study results, including a presentation at medical conferences or submissions to scientific journals.

We greatly appreciate the participation of our study volunteers.  We are all working together to improve the quality of life for ourselves and those around us.  We would never subject you to anything that could potentially create harm for you.  In fact, I tried SURGE on myself long before I ever tried on SURGE on any of my patients.

SURGE Study

Dr. Brandeis is part of the team developing a transdermal serum for the improvement of penile blood flow.  We are looking for 7 young healthy volunteers that we will pay $100, 7 healthy radical prostatectomy patients and 7 patients who have undergone radiation therapy.  Patient will be testing a new serum to improve penile blood flow and increase the strength of erectile function. The commitment will require 2 sessions, about 1 hour long, where we will perform ultrasound to assess vascular flow.  Patient will receive a free set of comprehensive laboratory studies, vascular ultrasound of the aorta and iliacs, and a month supply of serum. The risks of the study are minimal.