Post-Prostatectomy Erectile Dysfunction: Effect of Hyperbaric Oxygen Therapy
试验速览
- 阶段
- 4 期
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Erectile function domain of Internation Index of Erectile Function (IIEF)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •age 40-69
- •diagnosis of Stage I prostate cancer
- •bilateral NSRRP as primary treatment
- •sexual potency prior to surgery
排除标准
- •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
研究组 & 干预措施
1
干预措施: Sildenafil therapy plus post-NSRRP HBO2T (Drug)
2
干预措施: Sildenafil therapy plus sham post-NSRRP HBO2T (Drug)
结局指标
主要结局
Erectile function domain of Internation Index of Erectile Function (IIEF)
时间窗: 1, 3, 6, 12, and 18 months post surgery
次要结局
- clinical or biochemical recurrence of cancer(up to 10 years)