<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01714830</url>
  </required_header>
  <id_info>
    <org_study_id>IsfahanUMS1</org_study_id>
    <nct_id>NCT01714830</nct_id>
  </id_info>
  <brief_title>Efficacy of Extracorporal Shock Wave Therapy in Patient With Chronic Non-bacterial Prostatitis / Chronic Pelvic Pain Syndrome</brief_title>
  <official_title>The Efficacy of Extracorporal Shock Wave Therapy on Symptoms Relief in Patients With Chronic Non-bacterial Prostatitis / Chronic Pelvic Pain Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Isfahan University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Isfahan University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Chronic pelvic pain (CPP) can affect both sexes and lasts at least for 3 months. CPP in women&#xD;
      could be due to endometrioses, ovarian cyst, colitis, etc, making the correct diagnosis&#xD;
      important (1-3). The most prevalent reason for CPP in men is non-bacterial chronic&#xD;
      prostatitis and in many cases they are considered equivalent to each other (4).&#xD;
&#xD;
      Chronic non-bacterial prostatitis is associated with pain in pelvic region and could be&#xD;
      associated with other symptoms such as dysuria, myalgia, arthralgia, chronic fatigue, burning&#xD;
      sensation in the urethra, abdominal, urine frequency, and pain after ejaculation (4-6).&#xD;
      Chronic prostatitis / chronic pelvic pain syndrome (CP/CPPS) is devided into two groups: III&#xD;
      A Type (inflammatory) and III B (Non-inflammatory). The difference between the two groups is&#xD;
      the presence of leukocytes in prostatic secretions after prostate massage, urine and semen&#xD;
      (7,8).&#xD;
&#xD;
      In general population, the prevalence of chronic pelvic pain syndrome is about 0.5 percent&#xD;
      because many patients do not consider their symptoms as disease, while 6.3% of people may&#xD;
      show symptoms (9-11).&#xD;
&#xD;
      One of the most important challenges in the treatment of chronic prostatitis / chronic pelvic&#xD;
      pain syndrome, is that its etiology is obscure and it is known as a multi-factorial syndrome.&#xD;
      The proposed explanations are infection, psychological reasons, autoimmunity and&#xD;
      neuro-myospasm. Hypotheses about endothelial cells defect and cardio vascular disease have&#xD;
      also been proposed, upon which the new therapies have been based.&#xD;
&#xD;
      In duplex mapping study of prostatic vessels in two groups of healthy and chronic&#xD;
      non-bacterial prostatitis people, it was shown that there was a significant reduction in&#xD;
      systolic flow in prostatic arteries in people who had chronic non-bacterial prostatitis, and&#xD;
      there was a direct association between pain and blood flow intensity, suggesting chronic&#xD;
      ischemia as a possible cause for pain (13). Pain in prostate without significant infection is&#xD;
      the hallmark of chronic prostatitis / chronic pelvic pain syndrome (5). In physical exam,&#xD;
      prostate or pelvic tenderness may be observed in half of the patients.&#xD;
&#xD;
      The diagnosis of chronic prostatitis / chronic pelvic pain syndrome is challenging. No&#xD;
      specific lab test exists for its detection. Prostate specific antigen (PSA) level, which is&#xD;
      typically increased in acute infection, is usually normal in this condition. The diagnostic&#xD;
      approach in these patients is based on ruling out other curable causes such as benign&#xD;
      prostatic hyperplasia or bladder cancer (14-20).&#xD;
&#xD;
      NIH Chronic Prostatitis Symptom Index (NIH-CPSI) is used to evaluate symptom severity and&#xD;
      response to treatment in these patients. A reduction of 4-6 points in the score is considered&#xD;
      significant response to the treatment (21).&#xD;
&#xD;
      There is no first line treatment for patients of chronic pelvic pain syndrome. The use of&#xD;
      anti-bacterial, alpha-blockers or anti-inflammatory drug is logical. However, if the patient&#xD;
      does not respond, further administration is not helpful. In non-responders, combination of&#xD;
      drugs or other non-medical methods should be considered (23-26).&#xD;
&#xD;
      As discussed earlier, blood flow reduction, ischemia and disorders in endothelium of vessels&#xD;
      may cause pain in these patients and methods to improve blow flow may help(13,27). One of&#xD;
      these methods is extracorporeal shockwave therapy (ESWT) which is typically used for&#xD;
      tendonitis, acceleration in bone reunion and wound healing, improvement in muscle movements&#xD;
      through a reduction in passive muscular tonus, increasing muscular range of motion after&#xD;
      cerebrovascular accident (CVA), treatment of Peyronie's disease and erectile dysfunction&#xD;
      (28-30).&#xD;
&#xD;
      Shoskes et al compared 24 chronic prostatitis patients with 11 controls in terms of vascular&#xD;
      stiffness, indexes of increased blood flow, vasodilation and reactive vascular hyperemia,&#xD;
      using Endo-PAT ® 2000-Machine. They showed that endothelial disorder and stiffness along with&#xD;
      the risk of cardiovascular disorders are increased in CP/CPPS (31).&#xD;
&#xD;
      The use of ESWT for the treatment of CP/CPPS has been evaluated in a few studies. In a&#xD;
      double-blind randomized control trial, Zimmermann et al placed 60 patients with chronic&#xD;
      pelvic pain syndrome from chronic non-bacterial prostatitis into two groups and treated one&#xD;
      of them in 4 sessions with a frequency of 3000 per session. The treatment group showed&#xD;
      superior results in terms of symptom improvement(32).&#xD;
&#xD;
      In another study, Zimmermann et al followed 34 patients with chronic pelvic pain syndrome,&#xD;
      after one, four and twelve weeks post ESWT in terms of quality of life and pain reduction.&#xD;
      They showed that this method is useful and without any complications (33).&#xD;
&#xD;
      Considering the promising results of the cited articles along with the paucity of data in&#xD;
      this regard we decided to perform a double-blind sham-controlled study to evaluate the&#xD;
      effectiveness of ESWT in CP/CPPS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Eligible patients will sign an informed consent. Bacterial prostatitis will be ruled out by a&#xD;
      2-glass test (In this method a mid-stream urine sample is collected (10 ml of urine is&#xD;
      discarded and the second 10 ml of urine is collected) and then prostate massage is done for a&#xD;
      minute by Digital Rectal Exam and then another 10 ml of urine is collected.&#xD;
&#xD;
      After briefing the patients about the method and obtaining written consent from, he will be&#xD;
      randomly allocated into either the treatment or control group.&#xD;
&#xD;
      In the first group patients will be treated by ESWT once a week for 4 weeks. (Each time 3000&#xD;
      impulses, with 0.25 mJouls/M2 and 3 Hertz of frequency. After each 500 pulses, the probe&#xD;
      position will be corrected, using trans-perineal ultrasound. The used device in this study is&#xD;
      the standars electromagnetic DUOLITH SD1- shock waves against erectile dysfunction.&#xD;
&#xD;
      In the control group, the same protocol is applied but with the probe being turned off.&#xD;
&#xD;
      The examination is performed in supine position for patient. For each patient, pelvic pain&#xD;
      intensity considering is performed at the beginning and end of study, by VAS. Patients are&#xD;
      considered by doctor for NIH index at the beginning and end of study.&#xD;
&#xD;
      Finally, obtained data about pain relief and change in NIH-CPSI are recorded in special&#xD;
      profile for each patient and finally are analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>August 2011</start_date>
  <primary_completion_date type="Anticipated">November 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>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</measure>
    <time_frame>12 months</time_frame>
    <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.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Extracorporal Shock Wave Therapy</condition>
  <condition>Chronic Non-bacterial Prostatitis</condition>
  <condition>Chronic Pelvic Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>sham group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>the same protocol is applied but with the probe being turned off.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>treatment group</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>patients will be treated by ESWT once a week for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>standars electromagnetic DUOLITH SD1</intervention_name>
    <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.</description>
    <arm_group_label>treatment group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>turn off standars electromagnetic DUOLITH SD1</intervention_name>
    <description>In the control group, the same protocol is applied but with the probe being turned off.</description>
    <arm_group_label>sham group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Non-addiction to drugs and narcotics.&#xD;
&#xD;
          2. Chronic pelvic pain existence for more than three month and certain diagnosis of&#xD;
             chronic non-bacterial / chronic pelvic pain syndrome.&#xD;
&#xD;
          3. Signing an informed consent for treatment by ESWT&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. To be under treatment by another method at the beginning of the study&#xD;
&#xD;
          2. Another diagnosis such as prostate cancer is suggested during work-up.&#xD;
&#xD;
          3. Therapy plan alteration.&#xD;
&#xD;
          4. Non-inclination to continue this project.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Farshid Alizadeh, pediatric urologist</last_name>
    <role>Principal Investigator</role>
    <affiliation>Isfahan University of Medical Sciense</affiliation>
  </overall_official>
  <verification_date>October 2012</verification_date>
  <study_first_submitted>October 12, 2012</study_first_submitted>
  <study_first_submitted_qc>October 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 26, 2012</study_first_posted>
  <last_update_submitted>October 23, 2012</last_update_submitted>
  <last_update_submitted_qc>October 23, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Isfahan University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Farshid Alizadeh</investigator_full_name>
    <investigator_title>pediatric urologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatitis</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Shock</mesh_term>
    <mesh_term>Pelvic Pain</mesh_term>
    <mesh_term>Somatoform Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01714830
org study id: IsfahanUMS1
nct id: NCT01714830
lead sponsor: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: 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
time frame: 12 months
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.
arm group label: sham group
arm group type: Sham Comparator
description: the same protocol is applied but with the probe being turned off.
arm group label: treatment group
arm group type: Sham Comparator
description: patients will be treated by ESWT once a week for 4 weeks
intervention type: Device
intervention name: standars electromagnetic DUOLITH SD1
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.
arm group label: treatment group
intervention type: Device
intervention name: turn off standars electromagnetic DUOLITH SD1
description: In the control group, the same protocol is applied but with the probe being turned off.
arm group label: sham group
criteria: 
gender: Male
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Farshid Alizadeh, pediatric urologist
role: Principal Investigator
affiliation: Isfahan University of Medical Sciense
responsible party type: Principal Investigator
investigator affiliation: Isfahan University of Medical Sciences
investigator full name: Farshid Alizadeh
investigator title: pediatric urologist
mesh term: Prostatitis
mesh term: Syndrome
mesh term: Shock
mesh term: Pelvic Pain
mesh term: Somatoform Disorders