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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Prostatitis, Chronic Pelvic Pain Syndrome

Intervention / Treatment
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* Device: Electromagnetic Stimulation Therapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Electromagnetic stimulation<br>Electromagnetic stimulation therapy | Device: Electromagnetic Stimulation Therapy<br>* Electromagnetic Stimulation Therapy for 24 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electromagnetic Stimulation Therapy, Chronic Prostatitis, Chronic Pelvic Pain Syndrome