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Spots Global Cancer Trial Database for Can Hyperbaric Oxygen Improve Erectile Function Following Surgery for Prostate Cancer

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Trial Identification

Brief Title: Can Hyperbaric Oxygen Improve Erectile Function Following Surgery for Prostate Cancer

Official Title: Post-Prostatectomy Erectile Dysfunction: Effect of Hyperbaric Oxygen Therapy

Study ID: NCT00906269

Study Description

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

Minimum Age: 40 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: MALE

Healthy Volunteers: No

Locations

Hartford Hospital, Hartford, Connecticut, United States

Contact Details

Name: James Graydon, MD

Affiliation: Hartford Hospital

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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