<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/NCT03024619</url>
  </required_header>
  <id_info>
    <org_study_id>26300</org_study_id>
    <nct_id>NCT03024619</nct_id>
  </id_info>
  <brief_title>Interstitial Cystitis and Urinary pH</brief_title>
  <official_title>A Pilot Study of the Correlation Between Symptoms of Interstitial Cystitis and Urinary pH</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a pilot study to assess the correlation between urinary pH and Interstitial Cystitis&#xD;
      (IC) pain, with emphasis placed on exploring the type and severity of pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects who agree to participate in the study will meet with a research team member who will&#xD;
      review the study with them, obtain informed consent sign the HIPPA form, and provide study&#xD;
      materials (void diary for urine quantification and recording of IC symptoms, pH strips to dip&#xD;
      urine, &quot;hat&quot; to measure urine). Medical charts will be reviewed to determined how&#xD;
      Interstitial Cystitis was diagnosed, medications, medical/surgical history, and demographics&#xD;
      such as weight, height, BMI, race, age, marital status, education, insurance, tobacco or&#xD;
      alcohol use. Subjects will need to dip pH paper into the urine and specific gravity reagent&#xD;
      strip, and, by color comparison between the strips and the corresponding scales, determine&#xD;
      and record urine pH and specific gravity. They will need to fill out the corresponding&#xD;
      section in the voiding diary that is a survey to type and severity or pain as well as other&#xD;
      symptoms of IC. The research team member will teach the subject how to measure the volume of&#xD;
      their urine and how to measure and record specific gravity and pH. When not practical to&#xD;
      record the volume of the urine (when patients are at work or away from home) they will still&#xD;
      be asked to record pH, specific gravity and experienced symptoms. Subjects will be asked to&#xD;
      perform the above described protocol with each episode of micturition for 3 days.&#xD;
&#xD;
      After enrollment, subjects will complete the O'Leary-Sant pain (symptom and problem index)&#xD;
      questionnaire, if subjects have a combined score greater than or equal to 12 they are&#xD;
      considered to have problematic or symptomatic IC. The voiding diary that include pH and&#xD;
      specific gravity measurement measurements, times, volume, and survey of symptoms will be&#xD;
      returned 1-2 weeks following completion of 3 day void diary for a face-to-face meeting with a&#xD;
      research team member. Attempts will be made to have those meetings coincide with a clinical&#xD;
      visit to minimize study burden to the subject(e.g. - at the time of cystoscopy or follow-up&#xD;
      visit. )&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2016</start_date>
  <completion_date type="Actual">June 4, 2019</completion_date>
  <primary_completion_date type="Actual">June 4, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation between urinary pH and bladder pain.</measure>
    <time_frame>3 days</time_frame>
    <description>Measure urine pH and visual analog pain scale score and describe correlation between them.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation between urinary specific gravity and bladder pain.</measure>
    <time_frame>3 days</time_frame>
    <description>Measure urine specific gravity and visual analog pain scale score and describe correlation between them.</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Interstitial Cystitis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pain and Urinary pH</intervention_name>
    <description>assess the correlation between urinary pH and Interstitial Cystitis (IC) pain, with emphasis placed on exploring the type and severity of pain</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Women with symptomatic diagnosed Interstitial Cystitis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 18-70, with diagnosed Interstitial Cystitis (IC) and bladder pain present&#xD;
             during week preceding enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who are pregnant. Subjects with current UTI or are unwilling/unable to&#xD;
             provide consent.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ioana Marcu, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>St. Louis University</affiliation>
  </overall_official>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>September 3, 2021</last_update_submitted>
  <last_update_submitted_qc>September 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Iona Marcu, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cystitis</mesh_term>
    <mesh_term>Cystitis, Interstitial</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03024619
org study id: 26300
nct id: NCT03024619
lead sponsor: 
has dmc: No
This is a pilot study to assess the correlation between urinary pH and Interstitial Cystitis
      (IC) pain, with emphasis placed on exploring the type and severity of pain.
Subjects who agree to participate in the study will meet with a research team member who will
      review the study with them, obtain informed consent sign the HIPPA form, and provide study
      materials (void diary for urine quantification and recording of IC symptoms, pH strips to dip
      urine, "hat" to measure urine). Medical charts will be reviewed to determined how
      Interstitial Cystitis was diagnosed, medications, medical/surgical history, and demographics
      such as weight, height, BMI, race, age, marital status, education, insurance, tobacco or
      alcohol use. Subjects will need to dip pH paper into the urine and specific gravity reagent
      strip, and, by color comparison between the strips and the corresponding scales, determine
      and record urine pH and specific gravity. They will need to fill out the corresponding
      section in the voiding diary that is a survey to type and severity or pain as well as other
      symptoms of IC. The research team member will teach the subject how to measure the volume of
      their urine and how to measure and record specific gravity and pH. When not practical to
      record the volume of the urine (when patients are at work or away from home) they will still
      be asked to record pH, specific gravity and experienced symptoms. Subjects will be asked to
      perform the above described protocol with each episode of micturition for 3 days.

      After enrollment, subjects will complete the O'Leary-Sant pain (symptom and problem index)
      questionnaire, if subjects have a combined score greater than or equal to 12 they are
      considered to have problematic or symptomatic IC. The voiding diary that include pH and
      specific gravity measurement measurements, times, volume, and survey of symptoms will be
      returned 1-2 weeks following completion of 3 day void diary for a face-to-face meeting with a
      research team member. Attempts will be made to have those meetings coincide with a clinical
      visit to minimize study burden to the subject(e.g. - at the time of cystoscopy or follow-up
      visit. )
observational model: Cohort
time perspective: Retrospective
measure: Correlation between urinary pH and bladder pain.
time frame: 3 days
description: Measure urine pH and visual analog pain scale score and describe correlation between them.
measure: Correlation between urinary specific gravity and bladder pain.
time frame: 3 days
description: Measure urine specific gravity and visual analog pain scale score and describe correlation between them.
intervention type: Other
intervention name: Pain and Urinary pH
description: assess the correlation between urinary pH and Interstitial Cystitis (IC) pain, with emphasis placed on exploring the type and severity of pain
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Ioana Marcu, MD
role: Principal Investigator
affiliation: St. Louis University
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Iona Marcu, MD
investigator title: Principal Investigator
mesh term: Cystitis
mesh term: Cystitis, Interstitial
sharing ipd: No