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Post-Prostatectomy Erectile Dysfunction: Effect of Hyperbaric Oxygen Therapy

Phase 4
40 Years
65 Years
Open (Enrolling)
Impotence, Prostatic Neoplasms

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Trial Information

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.

Inclusion Criteria:

- male

- age 40-69

- diagnosis of Stage I prostate cancer

- bilateral NSRRP as primary treatment

- sexual potency prior to surgery

Exclusion Criteria:

- COPD, CHF, diabetes mellitus

- known inability to tolerate PDE5I

- confinement anxiety/claustrophobia

- planned adjuvant or neo-adjuvant therapy

- patients taking alpha blockers or nitrates

- patients with retinitis pigmentosa

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Erectile function domain of Internation Index of Erectile Function (IIEF)

Outcome Time Frame:

1, 3, 6, 12, and 18 months post surgery

Safety Issue:


Principal Investigator

James Graydon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Hartford Hospital


United States: Food and Drug Administration

Study ID:




Start Date:

July 2009

Completion Date:

January 2013

Related Keywords:

  • Impotence
  • Prostatic Neoplasms
  • impotence
  • prostatic neoplasms
  • hyperbaric oxygenation
  • Phosphodiesterase Inhibitors
  • Neoplasms
  • Prostatic Neoplasms
  • Erectile Dysfunction



Hartford HospitalHartford, Connecticut  06102-5037