<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/NCT01669694</url>
  </required_header>
  <id_info>
    <org_study_id>2011-317</org_study_id>
    <nct_id>NCT01669694</nct_id>
  </id_info>
  <brief_title>Pelvic Floor Physical Therapy-Biomarkers Project</brief_title>
  <official_title>Women's Urology Center-Physical Therapy-Biomarkers Project</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Kenneth Peters, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>William Beaumont Hospitals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is collecting serum and urine samples at various time points during pelvic floor&#xD;
      physical therapy for women with pelvic pain.The biomarkers will be analyzed for cytokines and&#xD;
      proteomics at various time points.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Collection points will be baseline, and at the last PT visit.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">October 2013</completion_date>
  <primary_completion_date type="Actual">October 2013</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>The change in biomarkers pre- and post-pelvic floor PT</measure>
    <time_frame>pre- and post- pelvic floor PT</time_frame>
    <description>Interim Analysis to be done as PI determines.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of biomarkers in relation to clinical findings</measure>
    <time_frame>pre- and post- pelvic floor PT</time_frame>
    <description>Clinical data and biomarkers will be analyzed.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">59</enrollment>
  <condition>Pelvic Pain</condition>
  <arm_group>
    <arm_group_label>Women with Pelvic Pain</arm_group_label>
    <description>Women with Pelvic Pain undergoing pelvic floor PT in the Beaumont Women's Urology Center</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pelvic floor PT with biomarkers</intervention_name>
    <description>Pelvic floor physical therapy and collection of urine for biomarker analysis.</description>
    <arm_group_label>Women with Pelvic Pain</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum and urine&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women in the Beaumont Women's Urology Center who have pelvic pain and are starting pelvic&#xD;
        floor PT in our center.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women in the Beaumont Women's Urology Center who have pelvic pain and are starting&#xD;
             pelvic floor PT in our center.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  all others&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Donna J Carrico, NP, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>William Beaumont Hospitals</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kenneth Peters, MD</last_name>
    <role>Study Chair</role>
    <affiliation>William Beaumont Hospitals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Beaumont Women's Urology Center</name>
      <address>
        <city>Royal Oak</city>
        <state>Michigan</state>
        <zip>48073</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>July 19, 2012</study_first_submitted>
  <study_first_submitted_qc>August 16, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>October 13, 2015</last_update_submitted>
  <last_update_submitted_qc>October 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 15, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>William Beaumont Hospitals</investigator_affiliation>
    <investigator_full_name>Kenneth Peters, MD</investigator_full_name>
    <investigator_title>Investigator</investigator_title>
  </responsible_party>
  <keyword>Pelvic Pain</keyword>
  <keyword>Pelvic Floor Physical Therapy</keyword>
  <keyword>Biomarkers</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pelvic Pain</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/NCT01669694
org study id: 2011-317
nct id: NCT01669694
lead sponsor: 
has dmc: No
This study is collecting serum and urine samples at various time points during pelvic floor
      physical therapy for women with pelvic pain.The biomarkers will be analyzed for cytokines and
      proteomics at various time points.
Collection points will be baseline, and at the last PT visit.
observational model: Cohort
time perspective: Prospective
measure: The change in biomarkers pre- and post-pelvic floor PT
time frame: pre- and post- pelvic floor PT
description: Interim Analysis to be done as PI determines.
measure: Evaluation of biomarkers in relation to clinical findings
time frame: pre- and post- pelvic floor PT
description: Clinical data and biomarkers will be analyzed.
arm group label: Women with Pelvic Pain
description: Women with Pelvic Pain undergoing pelvic floor PT in the Beaumont Women's Urology Center
intervention type: Other
intervention name: Pelvic floor PT with biomarkers
description: Pelvic floor physical therapy and collection of urine for biomarker analysis.
arm group label: Women with Pelvic Pain
serum and urine
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Donna J Carrico, NP, MS
role: Principal Investigator
affiliation: William Beaumont Hospitals
last name: Kenneth Peters, MD
role: Study Chair
affiliation: William Beaumont Hospitals
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: William Beaumont Hospitals
investigator full name: Kenneth Peters, MD
investigator title: Investigator
mesh term: Pelvic Pain