Can Hyperbaric Oxygen Improve Erectile Function Following Surgery for Prostate Cancer (HBOT)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Impotence Prostatic Neoplasms |
Drug: Sildenafil therapy plus post-NSRRP HBO2T Drug: Sildenafil therapy plus sham post-NSRRP HBO2T |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Post-Prostatectomy Erectile Dysfunction: Effect of Hyperbaric Oxygen Therapy |
- Erectile function domain of Internation Index of Erectile Function (IIEF) [ Time Frame: 1, 3, 6, 12, and 18 months post surgery ] [ Designated as safety issue: No ]
- clinical or biochemical recurrence of cancer [ Time Frame: up to 10 years ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | January 2013 |
| Estimated Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: 1 |
Drug: Sildenafil therapy plus post-NSRRP HBO2T
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.
Other Name: Viagra
|
| Sham Comparator: 2 |
Drug: Sildenafil therapy plus sham post-NSRRP HBO2T
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.
Other Name: Viagra
|
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| Ages Eligible for Study: | 40 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Contact: Alison Champagne, BS | 860-545-6049 | achampa@harthosp.org |
| Contact: Ilene Staff, PhD | 860-545-0178 | IStaff@harthosp.org |
| United States, Connecticut | |
| Hartford Hospital | Recruiting |
| Hartford, Connecticut, United States, 06106 | |
| Contact: James Graydon, MD 860-947-8500 jgraydo@harthosp.org | |
| Principal Investigator: | James Graydon, MD | Hartford Hospital |
More Information
Additional Information:
Publications:
| Responsible Party: | Hartford Hospital |
| ClinicalTrials.gov Identifier: | NCT00906269 History of Changes |
| Other Study ID Numbers: | STAF001982HU |
| Study First Received: | May 19, 2009 |
| Last Updated: | May 18, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
Keywords provided by Hartford Hospital:
|
impotence prostatic neoplasms hyperbaric oxygenation Phosphodiesterase Inhibitors |
Additional relevant MeSH terms:
|
Neoplasms Prostatic Neoplasms Erectile Dysfunction Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Genital Diseases, Male Prostatic Diseases Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Sexual and Gender Disorders |
Mental Disorders Phosphodiesterase Inhibitors Sildenafil Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Vasodilator Agents Cardiovascular Agents Therapeutic Uses Phosphodiesterase 5 Inhibitors |
ClinicalTrials.gov processed this record on May 22, 2013