Can Hyperbaric Oxygen Improve Erectile Function Following Surgery for Prostate Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Impotence, Prostatic Neoplasms

Intervention / Treatment
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* Drug: Sildenafil therapy plus post-NSRRP HBO2T
* Drug: Sildenafil therapy plus sham post-NSRRP HBO2T


Participation Criteria
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Eligibility 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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Sildenafil therapy plus post-NSRRP HBO2T<br>* Sildenafil (Viagra) 50 mg - PO QHS for 12 months beginning the first evening they return home from surgical hospital stay PLUS Post-NSRRP hyperbaric oxygen therapy (90 minutes of 100% oxygen at 2.2ATA (equivalent to the pressure exerted at a depth of approximately 40 feet below sea level). There will be 5 or 10 treatments. The full treatment cycle will be completed within 2 weeks.<br>* Other names: Viagra;|
| Sham Comparator: 2<br> | Drug: Sildenafil therapy plus sham post-NSRRP HBO2T<br>* Sildenafil (Viagra)50 mg - PO QHS for 12 months beginning the first evening they return home from surgical hospital stay PLUS Post-NSRRP sham hyperbaric oxygen therapy - 90 minutes at 2.2ATA but instead of 100% oxygen, they will receive air administered via the oxygen hoods, as if they were being administered oxygen. Participants in this group will receive 5 or 10 sham treatment sessions. Full treatment cycle will be completed within 2 weeks.<br>* Other names: Viagra;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile function domain of Internation Index of Erectile Function (IIEF) |  | 1, 3, 6, 12, and 18 months post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical or biochemical recurrence of cancer |  | up to 10 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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impotence, prostatic neoplasms, hyperbaric oxygenation, Phosphodiesterase Inhibitors