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

Primary Purpose

Chronic Prostatitis, Chronic Pelvic Pain Syndrome

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Electromagnetic Stimulation Therapy
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Prostatitis focused on measuring Electromagnetic Stimulation Therapy, Chronic Prostatitis, Chronic Pelvic Pain Syndrome

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Electromagnetic stimulation

Arm Description

Electromagnetic stimulation therapy

Outcomes

Primary Outcome Measures

Change in NIH-CPSI total and pain score

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

Full Information

First Posted
June 16, 2009
Last Updated
May 10, 2011
Sponsor
Samsung Medical Center
Collaborators
M-cube technology
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1. Study Identification

Unique Protocol Identification Number
NCT00922012
Brief Title
Efficacy of Electromagnetic Stimulation Therapy for Chronic Prostatitis and Chronic Pelvic Pain Syndrome
Official Title
Efficacy of Electromagnetic Stimulation Therapy for the Treatment of Chronic Prostatitis or Chronic Pelvic Pain Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
March 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Samsung Medical Center
Collaborators
M-cube technology

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Prostatitis, Chronic Pelvic Pain Syndrome
Keywords
Electromagnetic Stimulation Therapy, Chronic Prostatitis, Chronic Pelvic Pain Syndrome

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Electromagnetic stimulation
Arm Type
Experimental
Arm Description
Electromagnetic stimulation therapy
Intervention Type
Device
Intervention Name(s)
Electromagnetic Stimulation Therapy
Intervention Description
Electromagnetic Stimulation Therapy for 24 weeks
Primary Outcome Measure Information:
Title
Change in NIH-CPSI total and pain score
Time Frame
24 weeks after treatment
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kyu-Sung Lee, Ph.D
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of

12. IPD Sharing Statement

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

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