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Main
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Note: This record shows only the 20 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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17 October 2012 |
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Main ID: |
NCT00422708 |
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Date of registration:
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15/01/2007 |
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Primary sponsor: |
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Public title:
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Local Anesthesia for Prostate Biopsy
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Scientific title:
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Local Anesthesia for Prostate Biopsy: Effects on Pain Control, Quality of Life, and Surgical Intervention |
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Date of first enrolment:
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June 2006 |
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Target sample size:
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243 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00422708 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment
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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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Richard A. Ashley, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Mayo Clinic |
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Key inclusion & exclusion criteria
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Our study will not exclude patients based on age or race. Any male patient seen in our
clinic with the following conditions that warrant and consent to transrectal needle biopsy
of the prostate would be recruited for this study:
1. Elevated serum PSA
2. Hypoechoic nodule incidentally discovered on transrectal ultrasound for other
purposes
3. Abnormal digital rectal exam (DRE)
The following exclusion criteria must be in place to prevent complications and
interference with data interpretation:
1. Patients taking narcotics on a routine basis
2. Patients on Coumadin therapy
3. Patients with ano-rectal disease
4. Patients with history of prostatitis, pelvic pain, pelvic floor tension myalgia, or
other pain syndromes
5. Patients with active prostate abscess or urinary tract infection
6. Patients with allergy to local anesthetic
Age minimum:
18 Years
Age maximum:
90 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Procedure: Local anesthesia
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Primary Outcome(s)
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Pain contol
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Secondary Outcome(s)
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Changes to bowel function
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Changes to sexual function
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Changes to voiding function
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Impact on surgical treatment
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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