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

This study has been completed.
Sponsor:
Collaborator:
M-cube technology
Information provided by:
Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00922012
First received: June 16, 2009
Last updated: May 10, 2011
Last verified: May 2011
  Purpose

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/inflammation, thereby, restoring more normal pelvic floor muscular activity.


Condition Intervention
Chronic Prostatitis
Chronic Pelvic Pain Syndrome
Device: Electromagnetic Stimulation Therapy

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy of Electromagnetic Stimulation Therapy for the Treatment of Chronic Prostatitis or Chronic Pelvic Pain Syndrome

Resource links provided by NLM:


Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • Change in NIH-CPSI total and pain score [ Time Frame: 24 weeks after treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: November 2007
Study Completion Date: December 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electromagnetic stimulation
Electromagnetic stimulation therapy
Device: Electromagnetic Stimulation Therapy
Electromagnetic Stimulation Therapy for 24 weeks
Other Name: Electromagnetic Stimulation Therapy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: male patients with

  • Age ≥ 18
  • NIDDK category III chronic prostatitis/chronic pelvic pain syndrome
  • Symptom duration ≥ 3 months
  • The sum of 1 or 2 domain of NIH-CPSI ≥ 1 point
  • The sum NIH-CPSI ≥ 15 points

Exclusion Criteria: patients with

  • History of prostate cancer
  • History of pelvic irradiation
  • History of transurethral surgery
  • Urinary tract infection within 6 months to screening
  • Postvoid urine volume ≥ 150ml
  • Interstitial cystitis
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00922012

Locations
Korea, Republic of
Samsung Medical Center
Seoul, Korea, Republic of, 135-710
Sponsors and Collaborators
Samsung Medical Center
M-cube technology
Investigators
Principal Investigator: Kyu-Sung Lee, Ph.D Samsung Medical Center
  More Information

No publications provided

Responsible Party: Kyu-Sung Lee/Professor, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00922012     History of Changes
Other Study ID Numbers: 2007-08-064
Study First Received: June 16, 2009
Last Updated: May 10, 2011
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Samsung Medical Center:
Electromagnetic Stimulation Therapy
Chronic Prostatitis
Chronic Pelvic Pain Syndrome

Additional relevant MeSH terms:
Pelvic Pain
Syndrome
Pain
Somatoform Disorders
Prostatitis
Chronic Disease
Mental Disorders
Signs and Symptoms
Prostatic Diseases
Genital Diseases, Male
Disease
Pathologic Processes
Disease Attributes

ClinicalTrials.gov processed this record on September 22, 2014