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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT00906269 |
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Date of registration:
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19/05/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Can Hyperbaric Oxygen Improve Erectile Function Following Surgery for Prostate Cancer
HBOT |
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Scientific title:
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Post-Prostatectomy Erectile Dysfunction: Effect of Hyperbaric Oxygen Therapy |
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Date of first enrolment:
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July 2009 |
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Target sample size:
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100 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT00906269 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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James Graydon, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hartford Hospital |
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Key inclusion & exclusion criteria
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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
Age minimum:
40 Years
Age maximum:
65 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Impotence
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Prostatic Neoplasms
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Intervention(s)
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Drug: Sildenafil therapy plus post-NSRRP HBO2T
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Drug: Sildenafil therapy plus sham post-NSRRP HBO2T
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Primary Outcome(s)
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Erectile function domain of Internation Index of Erectile Function (IIEF)
[Time Frame: 1, 3, 6, 12, and 18 months post surgery]
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Secondary Outcome(s)
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clinical or biochemical recurrence of cancer
[Time Frame: up to 10 years]
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Secondary ID(s)
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STAF001982HU
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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