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| Sponsor: | Hartford Hospital |
|---|---|
| Information provided by: | Hartford Hospital |
| ClinicalTrials.gov Identifier: | NCT00906269 |
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 IV |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Post-Prostatectomy Erectile Dysfunction: Effect of Hyperbaric Oxygen Therapy |
| 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 |
|---|---|
| 1: Active Comparator |
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. Initial treatment will be started at 4-8 hours post-NSRRP, by 1:30 p.m. (the last regularly scheduled HBO2T chamber session), then daily (excluding Saturday, Sunday and holidays) for 9 additional days. The full treatment cycle lasts approximately two weeks
|
| 2: Sham Comparator |
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; initial session starting at 4-8 hours post-NSRRP, by 1:30 p.m., then once a day for the next two weekdays and for two days the following week.
|
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.
Two Comparison groups: Patients receive either PDE5I alone or PDE5I plus sham hyperbaric oxygen therapy (in chamber with air delivered rather than pure oxygen)
Eligibility| Ages Eligible for Study: | 40 Years to 69 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 | |
| Hartford, Connecticut, United States, 06106 | |
| Principal Investigator: | James Graydon, MD | Hartford Hospital |
More Information
| Responsible Party: | Hartford Hospital ( James Graydon, MD/Urology ) |
| Study ID Numbers: | STAF001982HU |
| Study First Received: | May 19, 2009 |
| Last Updated: | May 22, 2009 |
| ClinicalTrials.gov Identifier: | NCT00906269 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
impotence prostatic neoplasms hyperbaric oxygenation Phosphodiesterase Inhibitors |
|
Sexual Dysfunctions, Psychological Vasodilator Agents Molecular Mechanisms of Pharmacological Action Genital Neoplasms, Male Prostatic Diseases Enzyme Inhibitors Sildenafil Urogenital Neoplasms Cardiovascular Agents Genital Diseases, Male |
Sexual and Gender Disorders Pharmacologic Actions Neoplasms Neoplasms by Site Sexual Dysfunction, Physiological Phosphodiesterase Inhibitors Mental Disorders Therapeutic Uses Prostatic Neoplasms Erectile Dysfunction |
