Prostatic Neoplasms Clinical Trial
— HBOTOfficial title:
Post-Prostatectomy Erectile Dysfunction: Effect of Hyperbaric Oxygen Therapy
Verified date | May 2019 |
Source | Hartford Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 100 |
Est. completion date | January 2021 |
Est. primary completion date | July 2020 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 40 Years to 65 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Hartford Hospital | Hartford | Connecticut |
Lead Sponsor | Collaborator |
---|---|
Hartford Hospital |
United States,
Burnett AL. Erectile dysfunction following radical prostatectomy. JAMA. 2005 Jun 1;293(21):2648-53. — View Citation
Feldmeier JJ. Hyperbaric oxygen: does it have a cancer causing or growth enhancing effect? In: Proceeding of the Concensus Conference sponsored by the European Society for Therapeutic Radiology and Oncology and the European Committee for Hyperbaric Medicine. Portugal 2001: 129-146
Feldmeier, J.J.,Chairman and Editor. Hyperbaric Oxygen 2003: Indications and Results. The Hyperbaric Oxygen Therapy Committee Report . Kensington, MD: Undersea and Hyperbaric Medicine Society, 2003.
Kaufman JM, Graydon RJ. Androgen replacement after curative radical prostatectomy for prostate cancer in hypogonadal men. J Urol. 2004 Sep;172(3):920-2. Review. — View Citation
Link RE, Su LM, Sullivan W, Bhayani SB, Pavlovich CP. Health related quality of life before and after laparoscopic radical prostatectomy. J Urol. 2005 Jan;173(1):175-9; discussion 179. — View Citation
Lowentritt BH, Scardino PT, Miles BJ, Orejuela FJ, Schatte EC, Slawin KM, Elliott SP, Kim ED. Sildenafil citrate after radical retropubic prostatectomy. J Urol. 1999 Nov;162(5):1614-7. — View Citation
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. — View Citation
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. — View Citation
Schwartz EJ, Wong P, Graydon RJ. Sildenafil preserves intracorporeal smooth muscle after radical retropubic prostatectomy. J Urol. 2004 Feb;171(2 Pt 1):771-4. — View Citation
Walsh PC, Donker PJ. Impotence following radical prostatectomy: insight into etiology and prevention. J Urol. 1982 Sep;128(3):492-7. — View Citation
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. — View Citation
Zamboni WA, Brown RE, Roth AC, Mathur A, Stephenson LL. Functional evaluation of peripheral-nerve repair and the effect of hyperbaric oxygen. J Reconstr Microsurg. 1995 Jan;11(1):27-9; discussion 29-30. — View Citation
* Note: There are 12 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Erectile function domain of Internation Index of Erectile Function (IIEF) | 1, 3, 6, 12, and 18 months post surgery | ||
Secondary | clinical or biochemical recurrence of cancer | up to 10 years |
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