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
|First Submitted Date ICMJE||September 13, 2005|
|First Posted Date ICMJE||September 19, 2005|
|Last Update Posted Date||April 7, 2017|
|Study Start Date ICMJE||November 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||change in symptom score; reflected in NIH-Symptom Index (CPSI) at Block Assessment Visit|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00194636 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||AUA score at Block Assessment Visit|
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Effectiveness of Sympathetic Plexus Block on Male Pelvic Pain (Prostatitis, Prostatodynia)|
|Official Title ICMJE||Effectiveness 0f Sympathetic Plexus Block on Male Pelvic Pain (Prostatitis, Prostatodynia)|
|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.|
Male pelvic pain is a common urological complaint. Oftentimes patients are given the diagnosis of chronic prostatitis. Although the term "chronic prostatitis" is commonly associated with infection, less than 5% of men presenting with pelvic pain are found to have evidence of urogenital infection with common pathogens. Because no etiology can usually be associated with the pain, chronic idiopathic prostatitis is now called male chronic pelvic pain syndrome (CPPS). Options proposed for the treatment of male CPPS have had limited and variable success rates.
Although several abnormalities of the nervous system have been proposed as possible causes of CPPS, the clinical nature of the disease suggests involvement of the sympathetic nervous system. The sympathetic nervous system may be involved in many regional pain syndromes, and in such situations, the term "sympathetically maintained pain" has been used with complex regional pain syndromes. Block of the sympathetic nerves supplying this region is commonly used to detect sympathetic nervous system involvement.
Sympathetic nerve blocks have been used in some clinical studies involving pelvic pain but most of these studies included cancer patients with pelvic pain. The type of sympathetic blocks used for pelvic pain is superior hypogastric plexus block and it involves instillation of neural blocking agents such as local anesthetic agents in the region of the plexus, usually under fluoroscopic control. Nociceptive afferent transmission from pelvic viscera is probably via the superior hypogastric plexus. This treatment option has not been systematically used for male CPPS.
In this study, a temporary block of the superior hypogastric plexus with bupivacaine will be used to assess the degree of sympathetic block with some electrodiagnostic tests. After the temporary nerve block, the analgesic efficacy will be monitored. Therefore, in this study, we hope not only to explain the sympathetic nature of the disease in more concrete terms but also propose a new therapeutic approach for male CPPS.
Men with a diagnosis of non-bacterial chronic pelvic pain who have not responded to treatment will be asked to participate in this study. The subjects will be randomly assigned to receive either active medication as the sympathetic plexus block or placebo. All other study elements will be identical for both groups.
Visit 1 will take approximately 4 hours at the University of Washington Medical Center Urology Clinic.
VISIT 2 will take approximately 4 hours at the University of Washington Medical Center Urology Clinic.
VISIT 3 will take about 4 hours and will take place one week following the procedure. The sympathetic blockage will be assessed for its side effects on sexual and voiding function with a through physical and neurological examination. The pain questionnaires NIH SX-Follow/up, AUA-Symptom Score, IIEF, PSS and Pain Drawing and the electrodiagnostic tests will be repeated.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Intervention ICMJE||Procedure: nerve block|
|Study Arms||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Suspended|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||November 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years to 65 Years (Adult, Older Adult)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00194636|
|Other Study ID Numbers ICMJE||24993|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||University of Washington|
|Study Sponsor ICMJE||University of Washington|
|Collaborators ICMJE||Paul G. Allen Family Foundation|
|PRS Account||University of Washington|
|Verification Date||October 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP