Can Hyperbaric Oxygen Improve Erectile Function Following Surgery for Prostate Cancer

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Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IVSupportive careActive40 to 69OtherSTAF001982HU
NCT00906269

Trial Description

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.

Further Study Information

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Helen and Harry Gray Cancer Center at Hartford Hospital

    James Graydon, MD, Principal Investigator
    Alison Champagne, BS
    Ph: 860-545-6049
    Email: achampa@harthosp.org

    Trial Sites

    U.S.A.

    Connecticut
    Hartford

    Helen and Harry Gray Cancer Center at Hartford Hospital

    James Graydon, MD
    Ph: 860-947-8500
    Email: jgraydo@harthosp.org

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT00906269
    ClinicalTrials.gov processed this data on February 27, 2015

    Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.