Clinical trial NCT00906269: Can Hyperbaric Oxygen Improve Erectile Function Following Surgery for Prostate Cancer
Official title: Post-Prostatectomy Erectile Dysfunction: Effect of Hyperbaric Oxygen Therapy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Impotence
Prostatic Neoplasms
Keywords: impotence
prostatic neoplasms
hyperbaric oxygenation
Phosphodiesterase Inhibitors
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 100
Sex: MALE
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if adding hyperbaric oxygen therapy, a therapy that delivers oxygen under slight pressure, to a drug treatment of PDE5I (such as Viagra, Levitra, Cialis)for men following surgery for prostate cancer will result in more men being able to continue to have erections.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Erectile function domain of Internation Index of Erectile Function (IIEF)
timeFrame: 1, 3, 6, 12, and 18 months post surgery
Secondary outcomes:
measure: clinical or biochemical recurrence of cancer
timeFrame: up to 10 years
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: James Graydon, MD
role: PRINCIPAL_INVESTIGATOR
References:
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