Can Hyperbaric Oxygen Improve Erectile Function Following Surgery for Prostate Cancer (HBOT)
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|ClinicalTrials.gov Identifier: NCT00906269|
Recruitment Status : Active, not recruiting
First Posted : May 21, 2009
Last Update Posted : May 20, 2019
|Condition or disease||Intervention/treatment||Phase|
|Impotence Prostatic Neoplasms||Drug: Sildenafil therapy plus post-NSRRP HBO2T Drug: Sildenafil therapy plus sham post-NSRRP HBO2T||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Post-Prostatectomy Erectile Dysfunction: Effect of Hyperbaric Oxygen Therapy|
|Study Start Date :||July 2009|
|Estimated Primary Completion Date :||July 2020|
|Estimated Study Completion Date :||January 2021|
|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
- Erectile function domain of Internation Index of Erectile Function (IIEF) [ Time Frame: 1, 3, 6, 12, and 18 months post surgery ]
- clinical or biochemical recurrence of cancer [ Time Frame: up to 10 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00906269
|United States, Connecticut|
|Hartford, Connecticut, United States, 06106|
|Principal Investigator:||James Graydon, MD||Hartford Hospital|