Post-Prostatectomy Erectile Dysfunction: Effect of Hyperbaric Oxygen Therapy
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Erectile function domain of Internation Index of Erectile Function (IIEF)
1, 3, 6, 12, and 18 months post surgery
No
James Graydon, MD
Principal Investigator
Hartford Hospital
United States: Food and Drug Administration
STAF001982HU
NCT00906269
July 2009
January 2013
Name | Location |
---|---|
Hartford Hospital | Hartford, Connecticut 06102-5037 |