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

NCT00922012 | Completed

• 1 other identifier: 2007-08-064
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Prostatitis; Chronic Pelvic Pain Syndrome

Keywords

Electromagnetic Stimulation Therapy; Chronic Prostatitis; Chronic Pelvic Pain Syndrome

Outcome Measures

Primary Outcomes (1)

• Change in NIH-CPSI total and pain score

  24 weeks after treatment

Secondary Outcomes (1)

• 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

Study Arms (1)

Electromagnetic stimulation

EXPERIMENTAL

Electromagnetic stimulation therapy

Device: Electromagnetic Stimulation Therapy

Interventions

Electromagnetic Stimulation Therapy DEVICE

Electromagnetic Stimulation Therapy for 24 weeks

Electromagnetic stimulation

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead
• M-cube technology: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, 135-710, South Korea

Location

Study Officials

• Kyu-Sung Lee, Ph.D

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 16, 2009
• First Posted: June 17, 2009
• Study Start: November 1, 2007
• Primary Completion: March 1, 2009
• Study Completion: December 1, 2009
• Last Updated: May 12, 2011

Record last verified: 2011-05

Locations

KR (1)