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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Prostatitis; Chronic Pelvic Pain Syndrome
• Intervention / Treatment: Device: Electromagnetic Stimulation Therapy

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 135-710
    • Samsung Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Electromagnetic stimulation; Electromagnetic stimulation therapy	Device: Electromagnetic Stimulation Therapy; Electromagnetic Stimulation Therapy for 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in NIH-CPSI total and pain score	24 weeks after treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
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	24 weeks of treatment

Collaborators and Investigators

• Sponsor: Samsung Medical Center
• Collaborators: M-cube technology

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (ACTUAL): March 1, 2009
• Study Completion (ACTUAL): December 1, 2009

Study Registration Dates

• First Submitted: June 16, 2009
• First Submitted That Met QC Criteria: June 16, 2009
• First Posted (ESTIMATE): June 17, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): May 12, 2011
• Last Update Submitted That Met QC Criteria: May 10, 2011
• Last Verified: May 1, 2011

More Information

Terms related to this study

• Keywords: Chronic Prostatitis; Chronic Pelvic Pain Syndrome; Electromagnetic Stimulation Therapy
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Pain; Neurologic Manifestations; Disease Attributes; Disease; Prostatic Diseases; Syndrome; Chronic Disease; Somatoform Disorders; Pelvic Pain; Prostatitis
• Other Study ID Numbers: 2007-08-064