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

This study has suspended participant recruitment.
(PI health issues)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00194636
First Posted: September 19, 2005
Last Update Posted: April 7, 2017
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.
Collaborator:
Paul G. Allen Family Foundation
Information provided by (Responsible Party):
University of Washington
  Purpose
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 Intervention Phase
Chronic Male Pelvic Pain Syndrome Prostatitis Procedure: nerve block Phase 4

Study Type: Interventional
Study Design: 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)

Resource links provided by NLM:


Further study details as provided by University of Washington:

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

Secondary Outcome Measures:
  • AUA score at Block Assessment Visit

Estimated Enrollment: 20
Study Start Date: November 2003
Estimated Study Completion Date: November 2006
  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (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.
  Contacts and Locations
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
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
Principal Investigator: Richard E Berger, MD Professor of Urology
  More Information

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00194636     History of Changes
Other Study ID Numbers: 24993
First Submitted: September 13, 2005
First Posted: September 19, 2005
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:
Pelvic Pain
Prostatitis
Pain
Neurologic Manifestations
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male