Clinical Trial: Efficacy of Electromagnetic Stimulation Therapy for Chronic Prostatitis and Chronic Pelvic Pain Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Efficacy of Electromagnetic Stimulation Therapy for the Treatment of Chronic Prostatitis or Chronic Pelvic Pain Syndrome

Brief Summary:

In 1995 the National Institutes of Health-National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) workshop reached a consensus on the definition and classification of prostatitis syndromes.The commonest and yet most poorly understood of these prostatitis syndromes is category III or chronic pelvic pain syndrome (CPPS). It has been shown that, while men with CPPS have significantly higher leukocyte counts in urine and expressed prostatic secretions compared with age matched controls, inflammation and infection do not necessarily correlate with symptom severity.

The lack of a direct relationship between inflammation and symptoms is supported through studies of prostate histopathology, in which moderate or severe inflammation was identified in only 5% of men with CPPS.Conventional treatment has focused on long, empirical courses of expensive broad-spectrum antibiotics, mostly of the quinolone class, with or without the concomitant use of an α-blocker and anti-inflammatory agents. At the turn of the 19th century stimulation with electrical current and changing magnetic fields was used to treat surface conditions associated with intractable pain, such as painful malignant ulcers. The analgesic benefits of pulsed electromagnetic fields for relieving pelvic pain has been investigated in women with tissue trauma and chronic refractory pelvic pain.Despite its uncertain etiology there is some evidence that the symptom complex found in CPPS may be founded at least in part in pelvic floor muscular dysfunction and/or neurogenic hypersensitivity/inflammation.

We hypothesized that the application of a electromagnetic stimulation to the perineum of the subject may result in neural excitation and pelvic floor muscle stimulation to a degree that breaks the cycle of tonic muscular spasm and neural hypersensitivity/infla

Detailed Summary:
Sponsor: Samsung Medical Center

Current Primary Outcome: Change in NIH-CPSI total and pain score [ Time Frame: 24 weeks after treatment ]

Original Primary Outcome: Same as current

Current Secondary Outcome: Changes in - NIH-CPSI urinary, QoL impact score - Qmax/PVR - frequency/24hrs - urgency episode/24hrs - Patient perception of treatment benefit, satisfaction, willingness to continue - Goal achievement - Patient's Perception of Symptom Improvement [ Time Frame: 24 weeks of treatment ]

Original Secondary Outcome: Same as current

Information By: Samsung Medical Center

Dates:
Date Received: June 16, 2009
Date Started: November 2007
Date Completion:
Last Updated: May 10, 2011
Last Verified: May 2011