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

This study has suspended participant recruitment.
(PI health issues)
Sponsor:
Collaborator:
Paul G. Allen Family Foundation
Information provided by:
University of Washington
ClinicalTrials.gov Identifier:
NCT00194636
First received: September 13, 2005
Last updated: October 17, 2007
Last verified: October 2007
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00194636     History of Changes
Other Study ID Numbers: 03-9426-A 02
Study First Received: September 13, 2005
Last Updated: October 17, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by University of Washington:
Prostatitis
Chronic Male Pelvic Pain Syndrome

Additional relevant MeSH terms:
Pelvic Pain
Prostatitis
Somatoform Disorders
Pain
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014