View Clinical Trial (Medical Research Study)
Post-Prostatectomy Erectile Dysfunction: Effect of Hyperbaric Oxygen Therapy
| City: |
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Hartford |
| State: |
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Connecticut |
| Zip Code: |
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06106 |
| Conditions: |
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Impotence - Prostatic Neoplasms |
| Purpose: |
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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.
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| Study Summary: |
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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.
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| Criteria: |
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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
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| NCT ID: |
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NCT00906269 |
| Primary Contact: |
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Principal Investigator
James Graydon, MD
Hartford Hospital
Alison Champagne, BS
Phone: 860-545-6049
Email: achampa@harthosp.org
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| Backup Contact: |
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Email: IStaff@harthosp.org
Ilene Staff, PhD
Phone: 860-545-0178
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| Location Contact: |
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Hartford, Connecticut 06106
United States
James Graydon, MD
Phone: 860-947-8500
Email: jgraydo@harthosp.org
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 24, 2013 |
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