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Background: Amniotic fluid has been used for centuries in several medical fields due to its inherent anti-scarring, anti-microbial and antiinflammatory properties.To date, the use of amniotic fluid has not been explored extensively in the field of urology in humans and this paper is the largest to report an in depth study of its use for treating male dysfunction.Objectives: To retrospectively observe and evaluate the safety and quantity of ProFlo, an Amniotic Fluid (AF) product used for injections in the treatment of men with Erectile Dysfunction.Design, Setting, Participants: This is a retrospective observational study performed at Z Urology in Coral Springs, Florida.78 patients were used for the clinical trial and patients were injected initially with 0.1 cc of Trimix followed by various aliquots of AF depending on physician preference and patient's condition.Patients with Erectile Dysfunction (ED) were injected intracavernosally at the base of the penis.Follow-up visits were conducted over a period of 6 months.Results: Screening was evaluated using the International Index of Erectile Function (IIEF-5) Questionnaire and Penile Doppler instrumentation.There were no major complications. Outcome Measurements and Statistical Analysis:There was a statistically significant improvement in IIEF score (P<0.001) and in Peak Systolic Velocity on Penile Doppler (P<0.001).Conclusions: Results indicate that there have been no significant adverse effects and that amniotic fluid is safe to be used homologously on the genitourinary system.ProFlo appears to be a safe alternative therapeutic option for men with Erectile Dysfunction.More research is required to evaluate its effectiveness in the treatment of ED. Patient Summary:The data indicates that Penile Doppler is an effective tool in evaluating PSV values before and after the ProFlo injections.This study shows ProFlo to be a viable candidate to treat male dysfunction with limited risk complications.
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PM et al. (2018) studied this question.
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