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Effectiveness of Sympathetic Plexus Block on Male Pelvic Pain (Prostatitis, Prostatodynia)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00194636
Recruitment Status : Suspended (PI health issues)
First Posted : September 19, 2005
Last Update Posted : April 7, 2017
Sponsor:
Collaborator:
Paul G. Allen Family Foundation
Information provided by (Responsible Party):
University of Washington

Brief Summary:
The purpose of this study is to investigate, by means of a temporary sympathetic nerve block, the involvement of the sympathetic nervous system in Chronic Pelvic Pain Syndrome (CPPS). This study may also result in a new therapeutic approach for male CPPS.

Condition or disease Intervention/treatment Phase
Chronic Male Pelvic Pain Syndrome Prostatitis Procedure: nerve block Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effectiveness 0f Sympathetic Plexus Block on Male Pelvic Pain (Prostatitis, Prostatodynia)
Study Start Date : November 2003
Study Completion Date : November 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pelvic Pain




Primary Outcome Measures :
  1. change in symptom score; reflected in NIH-Symptom Index (CPSI) at Block Assessment Visit

Secondary Outcome Measures :
  1. AUA score at Block Assessment Visit


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00194636


Locations
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United States, Washington
University of Washington - Urology Clinic
Seattle, Washington, United States, 98195
Sponsors and Collaborators
University of Washington
Paul G. Allen Family Foundation
Investigators
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Principal Investigator: Richard E Berger, MD Professor of Urology
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Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00194636    
Other Study ID Numbers: 24993
First Posted: September 19, 2005    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: October 2007
Keywords provided by University of Washington:
Prostatitis
Chronic Male Pelvic Pain Syndrome
Additional relevant MeSH terms:
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Prostatitis
Pelvic Pain
Pain
Neurologic Manifestations
Prostatic Diseases