<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/NCT03027076</url>
  </required_header>
  <id_info>
    <org_study_id>NA_00089692</org_study_id>
    <nct_id>NCT03027076</nct_id>
  </id_info>
  <brief_title>Microbiome of Urologic Chronic Pelvic Pain Syndrome</brief_title>
  <official_title>Microbiome Studies of Urologic Chronic Pelvic Pain Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Johns Hopkins University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Johns Hopkins University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research is being done to learn more about the bacteria that live in the genito-urinary&#xD;
      tract in subjects with urologic chronic pelvic pain syndrome (UCPPS).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This research is being done to learn more about the bacteria that live in the genito-urinary&#xD;
      tract in subjects with urologic chronic pelvic pain syndrome (UCPPS).&#xD;
&#xD;
      A microbiome is defined as &quot;the ecological community of commensal, symbiotic, and pathogenic&#xD;
      microorganisms that literally share our body space.&quot; (Lederberg, 2001) The present study is&#xD;
      designed to establish the prostate, urinary bladder and urethral microbiome in men with&#xD;
      chronic prostatitis/chronic pelvic pain syndrome or the urinary bladder and urethral&#xD;
      microbiome in women with interstitial cystitis/painful bladder syndrome.&#xD;
&#xD;
      The human urethra, bladder and prostate normally harbor microbial communities. The recent&#xD;
      advent of large-scale &quot;omics&quot; technologies allows a detailed analysis of those communities.&#xD;
      While current knowledge of the normal inhabitants of the human urogenital tract remains&#xD;
      incomplete, more than 90% of patients with UCPPS report the onset of symptoms following a&#xD;
      &quot;urinary tract infection&quot;. The causative agents in most of those cases remain unknown, partly&#xD;
      due to the limitations of older detection technologies that require the detection and&#xD;
      isolation of a single microorganism for implicating it as a causative agent. Furthermore,&#xD;
      many microbial species remain unculturable and therefore, are often undetectable using&#xD;
      standard technology.&#xD;
&#xD;
      The current project will utilize state-of-the-art &quot;omic&quot; technology to detect and identify&#xD;
      microbial species in the urethra and bladder of both men and women and the prostate of men.&#xD;
      Additionally, the inflammatory response that accompanies those microbial communities will be&#xD;
      characterized. Finally, the presence and number of microbial species will be correlated with&#xD;
      the intensity of the inflammatory response and the severity of symptoms that patients with&#xD;
      UCPPS experience.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Funding for project not secured&#xD;
  </why_stopped>
  <start_date type="Actual">November 2013</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>6 Months</target_duration>
  <primary_outcome>
    <measure>Microbiome</measure>
    <time_frame>Within 6 month period from baseline evaluation</time_frame>
    <description>Evaluate the microbiome at baseline, one &quot;good day&quot; (minimal or no symptoms) and one &quot;bad day&quot; (worst symptoms) within a 6 month period</description>
  </primary_outcome>
  <number_of_groups>4</number_of_groups>
  <enrollment type="Actual">0</enrollment>
  <condition>Prostatitis</condition>
  <condition>Chronic Prostatitis</condition>
  <condition>Interstitial Cystitis</condition>
  <condition>Painful Bladder Syndrome</condition>
  <condition>Bladder Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>Men with UCPPS</arm_group_label>
    <description>Genitourinary Specimen Collection for microbiome evaluation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Asymptomatic Men</arm_group_label>
    <description>Genitourinary Specimen Collection for microbiome evaluation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Women with UCPPS</arm_group_label>
    <description>Collect midstream urine samples</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Asymptomatic Women</arm_group_label>
    <description>Collect midstream urine samples</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Genitourinary Specimen Collection</intervention_name>
    <description>Collect urethral swab, urine before prostatic massage (pre-M), urine after prostatic massage (post-M) and Expressed Prostatic Secretion (EPS)</description>
    <arm_group_label>Asymptomatic Men</arm_group_label>
    <arm_group_label>Men with UCPPS</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Collect midstream urine samples</intervention_name>
    <description>Collect midstream urine samples</description>
    <arm_group_label>Asymptomatic Women</arm_group_label>
    <arm_group_label>Women with UCPPS</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      1. Urine from male and female participants&#xD;
&#xD;
        2. Expressed prostatic secretions (EPS) from male participants&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Community Sample&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Consent: Participant has signed and dated the Informed Consent document, approved by&#xD;
             the Johns Hopkins Medical Institutions Institutional Review Board;&#xD;
&#xD;
          -  Agreement: Participant agrees to participate in study procedures;&#xD;
&#xD;
          -  Age: Participant is at least 18 years of age;&#xD;
&#xD;
          -  Symptom Severity: Participant reports a response of at least 8 on the Pain Domain of&#xD;
             the NIH-Chronic Prostatitis Symptom Index (CPSI) Questionnaire;&#xD;
&#xD;
          -  Duration of Symptoms: Symptoms have been present for at least 3 months within the&#xD;
             preceding 6 months.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Urethral conditions: Participant has an ongoing symptomatic urethral stricture;&#xD;
&#xD;
          -  Bladder conditions: Participant has a history of cystitis caused by tuberculosis,&#xD;
             radiation therapy or cytoxan/cyclophosphamide therapy, augmentation cystoplasty or&#xD;
             cystectomy;&#xD;
&#xD;
          -  Testicular conditions: Participant diagnosed with unilateral orchialgia, without&#xD;
             pelvic symptoms;&#xD;
&#xD;
          -  Prostate conditions or procedures: Participant has a history of transurethral&#xD;
             microwave thermotherapy (TUMT), transurethral needle ablation (TUNA), balloon&#xD;
             dilation, prostate cryosurgery, or laser procedure;&#xD;
&#xD;
          -  Neurological diseases or disorders affecting the bladder: Parkinson disease, multiple&#xD;
             system atrophy, multiple sclerosis, spinal cord injury, cervical myelopathy, acute&#xD;
             transverse myelitis, diabetic cystopathy, or dysfunctional voiding (non-neurogenic&#xD;
             neurogenic bladder or Hinman syndrome);&#xD;
&#xD;
          -  Psychiatric conditions: Participant has current major psychiatric disorder or other&#xD;
             psychiatric or medical issues that would interfere with study participation (e.g.&#xD;
             dementia, psychosis, upcoming major surgery, etc.);&#xD;
&#xD;
          -  Malignancy: Participant has a history of cancer (with the exception of skin cancer).&#xD;
&#xD;
        Control group exclusion criteria:&#xD;
&#xD;
        In addition to the exclusion criteria listed above, additional criteria for control&#xD;
        subjects are as follows:&#xD;
&#xD;
          -  Chronic Pain: In the past year, symptoms of discomfort or pain in the pelvic region&#xD;
             for a period longer than 3 months within the preceding year;&#xD;
&#xD;
          -  Infection: Volunteers who have had a urinary tract infection with a urine culture&#xD;
             value of &gt;100,000 colony forming units/ml (CFU/ml) within the past three months.&#xD;
&#xD;
          -  Intravesical Therapy: Volunteers treated with intravesical chemotherapy or Bacillus&#xD;
             Calmette-Guerin (BCG) therapy;&#xD;
&#xD;
          -  Gastrointestinal Conditions: Volunteers with inflammatory bowel disease (such as&#xD;
             Crohn's disease or ulcerative colitis, but not irritable bowel syndrome).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Arthur L Burnett, MD, FACS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Johns Hopkins University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Johns Hopkins Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21287</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>January 18, 2017</study_first_submitted>
  <study_first_submitted_qc>January 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>August 28, 2017</last_update_submitted>
  <last_update_submitted_qc>August 28, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>prostatitis</keyword>
  <keyword>chronic prostatitis</keyword>
  <keyword>chronic pelvic pain syndrome</keyword>
  <keyword>interstitial cystitis</keyword>
  <keyword>painful bladder syndrome</keyword>
  <keyword>bladder pain syndrome</keyword>
  <keyword>biomarkers</keyword>
  <keyword>biological markers</keyword>
  <keyword>bacteria</keyword>
  <keyword>microbiome</keyword>
  <keyword>inflammation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystitis</mesh_term>
    <mesh_term>Cystitis, Interstitial</mesh_term>
    <mesh_term>Prostatitis</mesh_term>
    <mesh_term>Syndrome</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/NCT03027076
org study id: NA_00089692
nct id: NCT03027076
lead sponsor: 
has dmc: No
This research is being done to learn more about the bacteria that live in the genito-urinary
      tract in subjects with urologic chronic pelvic pain syndrome (UCPPS).
This research is being done to learn more about the bacteria that live in the genito-urinary
      tract in subjects with urologic chronic pelvic pain syndrome (UCPPS).

      A microbiome is defined as "the ecological community of commensal, symbiotic, and pathogenic
      microorganisms that literally share our body space." (Lederberg, 2001) The present study is
      designed to establish the prostate, urinary bladder and urethral microbiome in men with
      chronic prostatitis/chronic pelvic pain syndrome or the urinary bladder and urethral
      microbiome in women with interstitial cystitis/painful bladder syndrome.

      The human urethra, bladder and prostate normally harbor microbial communities. The recent
      advent of large-scale "omics" technologies allows a detailed analysis of those communities.
      While current knowledge of the normal inhabitants of the human urogenital tract remains
      incomplete, more than 90% of patients with UCPPS report the onset of symptoms following a
      "urinary tract infection". The causative agents in most of those cases remain unknown, partly
      due to the limitations of older detection technologies that require the detection and
      isolation of a single microorganism for implicating it as a causative agent. Furthermore,
      many microbial species remain unculturable and therefore, are often undetectable using
      standard technology.

      The current project will utilize state-of-the-art "omic" technology to detect and identify
      microbial species in the urethra and bladder of both men and women and the prostate of men.
      Additionally, the inflammatory response that accompanies those microbial communities will be
      characterized. Finally, the presence and number of microbial species will be correlated with
      the intensity of the inflammatory response and the severity of symptoms that patients with
      UCPPS experience.
observational model: Cohort
time perspective: Prospective
measure: Microbiome
time frame: Within 6 month period from baseline evaluation
description: Evaluate the microbiome at baseline, one "good day" (minimal or no symptoms) and one "bad day" (worst symptoms) within a 6 month period
arm group label: Men with UCPPS
description: Genitourinary Specimen Collection for microbiome evaluation
arm group label: Asymptomatic Men
description: Genitourinary Specimen Collection for microbiome evaluation
arm group label: Women with UCPPS
description: Collect midstream urine samples
arm group label: Asymptomatic Women
description: Collect midstream urine samples
intervention type: Procedure
intervention name: Genitourinary Specimen Collection
description: Collect urethral swab, urine before prostatic massage (pre-M), urine after prostatic massage (post-M) and Expressed Prostatic Secretion (EPS)
arm group label: Asymptomatic Men
arm group label: Men with UCPPS
intervention type: Procedure
intervention name: Collect midstream urine samples
description: Collect midstream urine samples
arm group label: Asymptomatic Women
arm group label: Women with UCPPS
1. Urine from male and female participants

        2. Expressed prostatic secretions (EPS) from male participants
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Arthur L Burnett, MD, FACS
role: Principal Investigator
affiliation: Johns Hopkins University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Cystitis
mesh term: Cystitis, Interstitial
mesh term: Prostatitis
mesh term: Syndrome
mesh term: Pelvic Pain
mesh term: Somatoform Disorders