Poster, Podium & Video Sessions
Presentation Authors: Michael Zahalsky*, Gina Dessources, Melissa Marchand, Coral Springs, FL, Jason Levy, Philadephia, PA
Introduction: There is demand for a non-pharmaceutical approach to treating Erectile Dysfunction (ED). Proflo is Amniotic Fluid (AF) which contains various cytokines and growth factors and is believed to facilitate angiogenesis and decrease inflammation. Therefore, it may prove to be a non-pharmacologic, long-term, cost effective alternative to treat ED.
To determining the effectiveness of AF as a sustainable treatment for ED
Methods: A retrospective chart review of patients injected with ProFlo AF was performed. Proflo is amniotic fluid from a FDA cleared tissue bank, Vivex. It meets all the criteria to be regulated under the Public Health Service Act section 361. It is minimally manipulated, not combined with anything, not dependent on the metabolic activity of living cells, and being used homologously, since it is from the Genitourinary System and being used on the Genitourinary system. According to FDA draft guidance, Amniotic Fluid is a nonstructural biologic product that serves a biochemical role. A Penile Doppler measuring peak systolic velocity (PSV) and the International Index of Erectile Function Questionnaire (IIEF-5) were used to assess changes in erectile function. Patients were injected with 1cc - 2cc's of AF, and followed up to 6 months.
Results: 35 patients were injected with ProFlo AF. 15 patients injected with AF had pre and post PSV values, 12 patients had pre and post IIEF-5 scores. The average PSV after Trimix injection before administering AF was 26.65 cm/s. After AF injection in follow up, the average PSV was 37.83 cm/s (two-tailed t-test p-value < 0.005). Similarly, an increase was observed in the IIEF score for the group. IIEF score ranged from 5 to 21.5 before the initial AF injection and were between 8 to 24 after AF injection (two-tailed t-test p-value < 0.05). Patients only complaints were of minimal bruising and pain at the injection site for 2-7 days after injections.
Conclusions: Our results are very promising and statistically significant. We found improved erections on ultrasound and by patient reporting. The majority of patients expressed satisfaction with overall results following injections. Previously, safety data from multiple institutions has been reported on ProFlo Amniotic Fluid. This is the first study to evaluate the effectiveness of ProFlo AF injections. ProFlo AF needs larger studies but may prove to be a safe, effective and non-invasive treatment in men with ED.
Source Of Funding: None
Drexel University College of Medicine / Hahnemann University Hospial
Jason A. Levy D.O. PGY-1 Urologic Surgery Resident Drexel University College of Medicine / Hahnemann University Hospital. Dr. Levy is a first year urologic surgery resident at Hahnemann University Hosital. He graduated with a degree in Chemistry / Biochemistry from the Universiy of Florida with Honors. He then obtained a masters degree at the University of South Florida. He completed his D.O. degree with honors at Nova Southeastern Universtiy College of Osteopathic medicine in Fort Lauderdale, Florida.
Saturday, May 13
3:30 PM – 5:30 PM