Can Hyperbaric Oxygen Improve Erectile Function Following Surgery for Prostate Cancer

Condition(s) targeted: Impotence; Prostatic Neoplasms

Intervention: Sildenafil therapy plus post-NSRRP HBO2T (Drug); Sildenafil therapy plus sham post-NSRRP HBO2T (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Hartford Hospital

Official(s) and/or principal investigator(s):
James Graydon, MD, Principal Investigator, Affiliation: Hartford Hospital

Overall contact:
Alison Champagne, BS, Phone: 860-545-6049, Email: achampa@harthosp.org

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.

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

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: Erectile function domain of Internation Index of Erectile Function (IIEF)

Secondary outcome:

clinical or biochemical recurrence of cancer

incidence of post-NSRRP surgical complications

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.

Two Comparison groups: Patients receive either PDE5I alone or PDE5I plus sham hyperbaric oxygen therapy (in chamber with air delivered rather than pure oxygen)

Minimum age: 40 Years. Maximum age: 69 Years. Gender(s): Male.

Criteria:

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

Alison Champagne, BS, Phone: 860-545-6049, Email: achampa@harthosp.org

Hartford Hospital, Hartford, Connecticut 06106, United States

Hartford Hospital Home Page

Related publications:

Burnett AL. Erectile dysfunction following radical prostatectomy. JAMA. 2005 Jun 1;293(21):2648-53.

Mulhall JP, Graydon RJ. The hemodynamics of erectile dysfunction following nerve-sparing radical retropubic prostatectomy. Int J Impot Res. 1996 Jun;8(2):91-4.

Walsh PC, Donker PJ. Impotence following radical prostatectomy: insight into etiology and prevention. J Urol. 1982 Sep;128(3):492-7. No abstract available.

Rosen RC, Riley A, Wagner G, Osterloh IH, Kirkpatrick J, Mishra A. The international index of erectile function (IIEF): a multidimensional scale for assessment of erectile dysfunction. Urology. 1997 Jun;49(6):822-30.

Wei JT, Dunn RL, Litwin MS, Sandler HM, Sanda MG. Development and validation of the expanded prostate cancer index composite (EPIC) for comprehensive assessment of health-related quality of life in men with prostate cancer. Urology. 2000 Dec 20;56(6):899-905.

Starting date: July 2009
Ending date: January 2013
Last updated: May 22, 2009