Can Hyperbaric Oxygen Improve Erectile Function Following Surgery for Prostate Cancer (HBOT)

Hartford Hospital

Status and phase: Unknown; Phase 4

Conditions: Impotence; Prostatic Neoplasms

Treatments: Drug: Sildenafil therapy plus sham post-NSRRP HBO2T; Drug: Sildenafil therapy plus post-NSRRP HBO2T

Study type: Interventional

Funder types: Other

Identifiers

NCT00906269

STAF001982HU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Male

Ages: 40 to 65 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

1

Active Comparator group

Treatment:

Drug: Sildenafil therapy plus post-NSRRP HBO2T

2

Sham Comparator group

Treatment:

Drug: Sildenafil therapy plus sham post-NSRRP HBO2T