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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: |
NCT00194636 |
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Date of registration:
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13/09/2005 |
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Primary sponsor: |
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Public title:
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Effectiveness of Sympathetic Plexus Block on Male Pelvic Pain (Prostatitis, Prostatodynia)
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Scientific title:
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Effectiveness 0f Sympathetic Plexus Block on Male Pelvic Pain (Prostatitis, Prostatodynia) |
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Date of first enrolment:
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November 2003 |
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Target sample size:
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20 |
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Recruitment status: |
Suspended |
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URL:
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http://clinicaltrials.gov/show/NCT00194636 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, 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 E Berger, 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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Professor of Urology |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Men with Chronic Pelvic Pain Syndrome who, for the past year, have not responded to
standard pain treatment modalities.
Exclusion Criteria:
- Urinary tract infection with common pathogens
- Treatment for prostate, bladder, renal, or other urinary malignancies.
- Back pain or rectal pain only
- Psychotic or suicidal men
- Post-surgical pain
- Pain from another source in genital the tract such as kidney stones or neoplasm
- Having had radiation therapy
- History of genitourinary tuberculosis
- Neurological abnormalities such as stroke, brain tumors, spinal tumors, spinal cord
injury and Parkinson's or Alzheimer's disease.
- Drug allergies
- Use of any drugs, such as antihypertensives, that would interfere with biochemical
and electrodiagnostic tests.
- Bleeding and clotting disorders such as factor deficiencies or anticoagulant drug
use.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Chronic Male Pelvic Pain Syndrome
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Prostatitis
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Intervention(s)
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Procedure: nerve block
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Primary Outcome(s)
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change in symptom score; reflected in NIH-Symptom Index (CPSI) at Block Assessment Visit
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Secondary Outcome(s)
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AUA score at Block Assessment Visit
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Secondary ID(s)
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03-9426-A 02
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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