Post-Prostatectomy Erectile Dysfunction: Effect of Hyperbaric Oxygen Therapy
Description:
Prostate cancer is the most common non-skin malignancy in men in the United States, with
approximately 232,000 diagnoses of adenocarcinoma projected for 2005. More than 150,000 of
these men are treated with radical prostatectomy. Common sequelae following successful NSRRP
(nerve-sparing radical retropubic prostatectomy)include urinary incontinence and sexual
dysfunction. Recent advances in surgery technique and treatment have been made but in spite
of aggressive management, recovery of sexual function is incomplete with fewer than one-fifth
reporting return to baseline. The etiology of erectile dysfunction following radical
prostatectomy results most probably from local surgical trauma and neurapraxia, which leads
to corpus cavernosal hypoxemia in the post-NSRRP period. This hypoxemia is believed to impact
negatively on the health and maintenance of the smooth muscle cells within the corpus
cavernosum. Hyperbaric oxygen therapy (HBO2T) is a unique modality that is able to provide
oxygen delivery to tissues that have been damaged by traumatic injury.
Hypothesis: The addition of post-NSRRP hyperbaric oxygen therapy (HBO2T) to a treatment of
phosphodiesterase type 5 inhibitor (PDE5I) will reduce the incidence of erectile dysfunction
(ED) and urinary incontinence when measured at 1, 3, 6, 12 and 18 months post-NSRRP for Stage
I prostate cancer.
Condition:
Impotence
Treatment:
Sildenafil therapy plus post-NSRRP HBO2T
Start Date:
July 2009
Sponsor:
Hartford Hospital
For More Information:
https://clinicaltrials.gov/show/NCT00906269