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

Not Applicable

Completed

• Conditions: Chronic Prostatitis; Chronic Pelvic Pain Syndrome
• Interventions: Device: Electromagnetic Stimulation Therapy

• Registration Number: NCT00922012
• Lead Sponsor: Samsung Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2009-03
• Study First Submitted: 2009-06-16
• Study First Submitted QC: 2009-06-16
• Study First Posted: 2009-06-17
• Study Completion: 2009-12
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-10
• Last Update Posted: 2011-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Electromagnetic stimulation	Electromagnetic Stimulation Therapy	Electromagnetic stimulation therapy

Primary Outcome Measures

Name	Time	Method
Change in NIH-CPSI total and pain score	24 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of