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
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, see Learn About Clinical Studies.

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:
Syndrome
Pelvic Pain
Prostatitis
Disease
Pathologic Processes
Pain
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male

ClinicalTrials.gov processed this record on September 18, 2014