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Efficacy of Extracorporal Shock Wave Therapy in Patient With Chronic Non-bacterial Prostatitis / Chronic Pelvic Pain Syndrome

Primary Purpose

Extracorporal Shock Wave Therapy, Chronic Non-bacterial Prostatitis, Chronic Pelvic Pain Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
standars electromagnetic DUOLITH SD1
turn off standars electromagnetic DUOLITH SD1
Sponsored by
Isfahan University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extracorporal Shock Wave Therapy

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. Non-addiction to drugs and narcotics.
  2. Chronic pelvic pain existence for more than three month and certain diagnosis of chronic non-bacterial / chronic pelvic pain syndrome.
  3. Signing an informed consent for treatment by ESWT

Exclusion Criteria:

  1. To be under treatment by another method at the beginning of the study
  2. Another diagnosis such as prostate cancer is suggested during work-up.
  3. Therapy plan alteration.
  4. Non-inclination to continue this project.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Sham Comparator

    Sham Comparator

    Arm Label

    sham group

    treatment group

    Arm Description

    the same protocol is applied but with the probe being turned off.

    patients will be treated by ESWT once a week for 4 weeks

    Outcomes

    Primary Outcome Measures

    effect of extracorporeal shock wave therapy on pain reduction according to visual analogue scale and NIH-CPSI scale in patients with chronic non-bacterial prostatitis / chronic pelvic pain syndrome
    For each patient, pelvic pain intensity considering is performed at the beginning and end of study, by visual analogue scale(VAS). Patients are considered by doctor for NIH index according to NIH-CPSI scale at the beginning and end of study.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 12, 2012
    Last Updated
    October 23, 2012
    Sponsor
    Isfahan University of Medical Sciences
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01714830
    Brief Title
    Efficacy of Extracorporal Shock Wave Therapy in Patient With Chronic Non-bacterial Prostatitis / Chronic Pelvic Pain Syndrome
    Official Title
    The Efficacy of Extracorporal Shock Wave Therapy on Symptoms Relief in Patients With Chronic Non-bacterial Prostatitis / Chronic Pelvic Pain Syndrome
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    November 2012 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Isfahan University of Medical Sciences

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Chronic pelvic pain (CPP) can affect both sexes and lasts at least for 3 months. CPP in women could be due to endometrioses, ovarian cyst, colitis, etc, making the correct diagnosis important (1-3). The most prevalent reason for CPP in men is non-bacterial chronic prostatitis and in many cases they are considered equivalent to each other (4). Chronic non-bacterial prostatitis is associated with pain in pelvic region and could be associated with other symptoms such as dysuria, myalgia, arthralgia, chronic fatigue, burning sensation in the urethra, abdominal, urine frequency, and pain after ejaculation (4-6). Chronic prostatitis / chronic pelvic pain syndrome (CP/CPPS) is devided into two groups: III A Type (inflammatory) and III B (Non-inflammatory). The difference between the two groups is the presence of leukocytes in prostatic secretions after prostate massage, urine and semen (7,8). In general population, the prevalence of chronic pelvic pain syndrome is about 0.5 percent because many patients do not consider their symptoms as disease, while 6.3% of people may show symptoms (9-11). One of the most important challenges in the treatment of chronic prostatitis / chronic pelvic pain syndrome, is that its etiology is obscure and it is known as a multi-factorial syndrome. The proposed explanations are infection, psychological reasons, autoimmunity and neuro-myospasm. Hypotheses about endothelial cells defect and cardio vascular disease have also been proposed, upon which the new therapies have been based. In duplex mapping study of prostatic vessels in two groups of healthy and chronic non-bacterial prostatitis people, it was shown that there was a significant reduction in systolic flow in prostatic arteries in people who had chronic non-bacterial prostatitis, and there was a direct association between pain and blood flow intensity, suggesting chronic ischemia as a possible cause for pain (13). Pain in prostate without significant infection is the hallmark of chronic prostatitis / chronic pelvic pain syndrome (5). In physical exam, prostate or pelvic tenderness may be observed in half of the patients. The diagnosis of chronic prostatitis / chronic pelvic pain syndrome is challenging. No specific lab test exists for its detection. Prostate specific antigen (PSA) level, which is typically increased in acute infection, is usually normal in this condition. The diagnostic approach in these patients is based on ruling out other curable causes such as benign prostatic hyperplasia or bladder cancer (14-20). NIH Chronic Prostatitis Symptom Index (NIH-CPSI) is used to evaluate symptom severity and response to treatment in these patients. A reduction of 4-6 points in the score is considered significant response to the treatment (21). There is no first line treatment for patients of chronic pelvic pain syndrome. The use of anti-bacterial, alpha-blockers or anti-inflammatory drug is logical. However, if the patient does not respond, further administration is not helpful. In non-responders, combination of drugs or other non-medical methods should be considered (23-26). As discussed earlier, blood flow reduction, ischemia and disorders in endothelium of vessels may cause pain in these patients and methods to improve blow flow may help(13,27). One of these methods is extracorporeal shockwave therapy (ESWT) which is typically used for tendonitis, acceleration in bone reunion and wound healing, improvement in muscle movements through a reduction in passive muscular tonus, increasing muscular range of motion after cerebrovascular accident (CVA), treatment of Peyronie's disease and erectile dysfunction (28-30). Shoskes et al compared 24 chronic prostatitis patients with 11 controls in terms of vascular stiffness, indexes of increased blood flow, vasodilation and reactive vascular hyperemia, using Endo-PAT ® 2000-Machine. They showed that endothelial disorder and stiffness along with the risk of cardiovascular disorders are increased in CP/CPPS (31). The use of ESWT for the treatment of CP/CPPS has been evaluated in a few studies. In a double-blind randomized control trial, Zimmermann et al placed 60 patients with chronic pelvic pain syndrome from chronic non-bacterial prostatitis into two groups and treated one of them in 4 sessions with a frequency of 3000 per session. The treatment group showed superior results in terms of symptom improvement(32). In another study, Zimmermann et al followed 34 patients with chronic pelvic pain syndrome, after one, four and twelve weeks post ESWT in terms of quality of life and pain reduction. They showed that this method is useful and without any complications (33). Considering the promising results of the cited articles along with the paucity of data in this regard we decided to perform a double-blind sham-controlled study to evaluate the effectiveness of ESWT in CP/CPPS.
    Detailed Description
    Eligible patients will sign an informed consent. Bacterial prostatitis will be ruled out by a 2-glass test (In this method a mid-stream urine sample is collected (10 ml of urine is discarded and the second 10 ml of urine is collected) and then prostate massage is done for a minute by Digital Rectal Exam and then another 10 ml of urine is collected. After briefing the patients about the method and obtaining written consent from, he will be randomly allocated into either the treatment or control group. In the first group patients will be treated by ESWT once a week for 4 weeks. (Each time 3000 impulses, with 0.25 mJouls/M2 and 3 Hertz of frequency. After each 500 pulses, the probe position will be corrected, using trans-perineal ultrasound. The used device in this study is the standars electromagnetic DUOLITH SD1- shock waves against erectile dysfunction. In the control group, the same protocol is applied but with the probe being turned off. The examination is performed in supine position for patient. For each patient, pelvic pain intensity considering is performed at the beginning and end of study, by VAS. Patients are considered by doctor for NIH index at the beginning and end of study. Finally, obtained data about pain relief and change in NIH-CPSI are recorded in special profile for each patient and finally are analyzed.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Extracorporal Shock Wave Therapy, Chronic Non-bacterial Prostatitis, Chronic Pelvic Pain Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    sham group
    Arm Type
    Sham Comparator
    Arm Description
    the same protocol is applied but with the probe being turned off.
    Arm Title
    treatment group
    Arm Type
    Sham Comparator
    Arm Description
    patients will be treated by ESWT once a week for 4 weeks
    Intervention Type
    Device
    Intervention Name(s)
    standars electromagnetic DUOLITH SD1
    Intervention Description
    In the first group patients will be treated by ESWT once a week for 4 weeks. (Each time 3000 impulses, with 0.25 mJouls/M2 and 3 Hertz of frequency. After each 500 pulses, the probe position will be corrected, using trans-perineal ultrasound.
    Intervention Type
    Device
    Intervention Name(s)
    turn off standars electromagnetic DUOLITH SD1
    Intervention Description
    In the control group, the same protocol is applied but with the probe being turned off.
    Primary Outcome Measure Information:
    Title
    effect of extracorporeal shock wave therapy on pain reduction according to visual analogue scale and NIH-CPSI scale in patients with chronic non-bacterial prostatitis / chronic pelvic pain syndrome
    Description
    For each patient, pelvic pain intensity considering is performed at the beginning and end of study, by visual analogue scale(VAS). Patients are considered by doctor for NIH index according to NIH-CPSI scale at the beginning and end of study.
    Time Frame
    12 months

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    90 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Non-addiction to drugs and narcotics. Chronic pelvic pain existence for more than three month and certain diagnosis of chronic non-bacterial / chronic pelvic pain syndrome. Signing an informed consent for treatment by ESWT Exclusion Criteria: To be under treatment by another method at the beginning of the study Another diagnosis such as prostate cancer is suggested during work-up. Therapy plan alteration. Non-inclination to continue this project.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Farshid Alizadeh, pediatric urologist
    Organizational Affiliation
    Isfahan University of Medical Sciense
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Efficacy of Extracorporal Shock Wave Therapy in Patient With Chronic Non-bacterial Prostatitis / Chronic Pelvic Pain Syndrome

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