A Double-Blind, Randomized Trial on the Efficacy and Safety of Hyperbaric Oxygenation Therapy in the Preservation of Erectile Function after Radical Prostatectomy

Abstract

We evaluated the efficacy and safety of hyperbaric oxygenation therapy to preserve erectile function as part of penile rehabilitation after robot assisted bilateral nerve sparing radical prostatectomy for prostate cancer. We performed a prospective, randomized, double-blind study from January 2009 to April 2013. Men 40 to 65 years old who underwent robot assisted bilateral nerve sparing radical prostatectomy were randomized 1:1 to the control or the treatment group. Participants were exposed to air as the control or to 100% oxygen as the treatment in hyperbaric conditions. The primary outcome was erectile function at 18 months as measured by IIEF (International Index of Erectile Function). Secondary outcomes were 12-month urinary symptoms, and 18-month sexual, urinary, bowel and hormonal related symptoms as measured by EPIC-26 (Expanded Prostate Index Composite-26). Adverse events and long-term cancer outcomes were monitored. Primary and secondary outcomes in the 2 groups were compared by the independent group t-test, the Wilcoxon rank sum test and the chi-square test of proportion. A total of 109 potent men were randomized to hyperbaric oxygenation therapy or the control group. A total of 43 men in the air group and 40 in the hyperbaric oxygenation therapy group completed the 18-month followup. No statistically significant differences were observed between the 2 groups on any outcome measure. This study revealed no difference in erectile recovery in men treated with hyperbaric oxygenation therapy vs placebo. Larger studies involving more diverse comorbidities and different hyperbaric oxygenation therapy regimens are needed to better evaluate the usefulness of hyperbaric oxygenation therapy for penile rehabilitation after radical prostatectomy.