Amniotic fluid allograft for the treatment of erectile dysfunction: a pilot series
Baumgarten, A1; Beilan, J1; Shah, B1; Slongo, J 1; Loeb, A1; Parker, J1; Carrion, R1
1: University of South Florida, United States
Objectives: Amniotic fluid allograft has been used by orthopedic surgeons in joint replacement procedures to expedite recovery. Although it consists of a host of elements that may be beneficial in the treatment of erectile dysfunction (ED), it has never been tested for this disease process. Proflo® (Urostem Biologics; Coral Springs, FL) is a human allograft derived from amniotic fluid that does not contain stem cells. We present our pilot series using AmnioFactor® amniotic fluid allograft injections for the treatment of ED.
Materials and Methods: After IRB approval, patients undergoing amniotic fluid allograft injections for the treatment of ED were prospectively identified. A baseline Sexual Health Inventory for Men (SHIM) score and a penile Doppler ultrasound were obtained on each patient prior to treatment. Each cycle was performed four to six weeks apart and consisted of 1.5 cc of amniotic fluid allograft injected into each corpora cavernosum for a total of 3 cc. All patients underwent at least two cycles, with a maximum of four cycles being offered. A post-treatment SHIM score and a post-treatment penile Doppler ultrasound were obtained for comparison. The primary endpoint was the development of post-treatment complications. Secondary endpoints looked to evaluate subjective improvement in erectile function (SHIM scores) and objective changes in peak systolic velocity (PSV) and end-diastolic velocity (EDV) on penile Doppler ultrasound.
Results: 6 patients underwent amniotic fluid allograft injections for the treatment of ED between October 2016 and February 2017. Median patient age was 59.5 years old (42-75). Median number of cycles was 3 (2-4). Median follow up was 181 days (101-336 days). No post-treatment complications were reported. 83.3% (5/6) of patients reported subjective improvement in their erectile function. Median change in SHIM score was +1.5 (0-3). Median change in PSV and EDV was +4.8 cm/s (-1.4-30.3) and -3.2 cm/s (-4.1-0.4) respectively.
Conclusions: Intracavernosal amniotic fluid allograft injections were safe during this study period and appear to have promising results in the treatment of ED. A larger study is needed to assess this modality’s overall efficacy.
Work supported by industry: no. The presenter or any of the authors act as a consultant, employee (part time or full time) or shareholder of an industry.Go Back