<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/NCT04405141</url>
  </required_header>
  <id_info>
    <org_study_id>UmraniyeERH</org_study_id>
    <nct_id>NCT04405141</nct_id>
  </id_info>
  <brief_title>Uroflowmetry Results and Vitamin D Levels</brief_title>
  <official_title>The Relationship Between Vitamin D Level and Lower Urinary Tract Symptoms in Women</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Umraniye Education and Research Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Umraniye Education and Research Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators aimed to evaluate the relationship between LUTS and vitamin D with&#xD;
      uroflowmetry parameters in female patients. They found no relation between vitamin D levels&#xD;
      and LUTS in respect to uroflowmetry. However, in low vitamin D patients, Ca is related with&#xD;
      urologic problems. The investigators believe that there is a need for studies emphasizing&#xD;
      serum Ca levels in addition to vitamin D levels in patients with LUTS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This retrospective cohort study included 186 female patients who admitted to LUTS.&#xD;
      Demographic characteristics, medical history, calcium (Ca) and vitamin D including laboratory&#xD;
      studies and uroflowmetry results as maximum urine flow rate (Qmax), average urine flow rate&#xD;
      (Qav), and voided volume (V) were recorded. Patients were divided into two groups according&#xD;
      to age (18-50 and ≥51) and vitamin D levels (&lt;20 and ≥20).&#xD;
&#xD;
      Laboratory parameters, uroflowmetry results, were compared between groups.&#xD;
&#xD;
      The study was approved by the local ethics committee&#xD;
      (approval#22/06/2018-09.29-54132726-000-14136). The study was conducted in accordance to the&#xD;
      Helsinki Declaration and Good Clinical Practices Guidelines.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">December 30, 2017</completion_date>
  <primary_completion_date type="Actual">December 30, 2017</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Other</time_perspective>
  </study_design_info>
  <target_duration>12 Years</target_duration>
  <primary_outcome>
    <measure>Uroflowmetry Results</measure>
    <time_frame>12 months</time_frame>
    <description>There was no significant relationship between age, creatinine, Qmax, Qav, V and vitamin D level (P&gt;0.05).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Vitamin D Levels</measure>
    <time_frame>12 months</time_frame>
    <description>The mean D vitamin level was 21.19ng/ml. D vitamin was &lt;20 ng/ml in %55.9 patients. There was no difference in the levels according to the age of all patients.</description>
  </secondary_outcome>
  <enrollment type="Actual">186</enrollment>
  <condition>Lower Urinary Tract Symptoms</condition>
  <condition>Vitamin D Deficiency</condition>
  <condition>Calcium Deficiency</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Female patients with low urinary tract symptoms.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Clinical diagnosis of low urinary tract symptom&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Urinary tract infection, Diabetes mellitus, Neurological disorder, Pregnancy Stone disease&#xD;
        Other urinary system disorders.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Because females are more related to low urinary tract symptoms.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 9, 2020</study_first_submitted>
  <study_first_submitted_qc>May 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 29, 2020</last_update_submitted>
  <last_update_submitted_qc>May 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Umraniye Education and Research Hospital</investigator_affiliation>
    <investigator_full_name>Sibel Ocak Serin</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Lower Urinary Tract Symptoms</keyword>
  <keyword>Vitamin D Deficiency</keyword>
  <keyword>Calcium Deficiency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vitamin D Deficiency</mesh_term>
    <mesh_term>Lower Urinary Tract Symptoms</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/NCT04405141
org study id: UmraniyeERH
nct id: NCT04405141
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigators aimed to evaluate the relationship between LUTS and vitamin D with
      uroflowmetry parameters in female patients. They found no relation between vitamin D levels
      and LUTS in respect to uroflowmetry. However, in low vitamin D patients, Ca is related with
      urologic problems. The investigators believe that there is a need for studies emphasizing
      serum Ca levels in addition to vitamin D levels in patients with LUTS.
This retrospective cohort study included 186 female patients who admitted to LUTS.
      Demographic characteristics, medical history, calcium (Ca) and vitamin D including laboratory
      studies and uroflowmetry results as maximum urine flow rate (Qmax), average urine flow rate
      (Qav), and voided volume (V) were recorded. Patients were divided into two groups according
      to age (18-50 and ≥51) and vitamin D levels (<20 and ≥20).

      Laboratory parameters, uroflowmetry results, were compared between groups.

      The study was approved by the local ethics committee
      (approval#22/06/2018-09.29-54132726-000-14136). The study was conducted in accordance to the
      Helsinki Declaration and Good Clinical Practices Guidelines.
observational model: Case-Only
time perspective: Other
measure: Uroflowmetry Results
time frame: 12 months
description: There was no significant relationship between age, creatinine, Qmax, Qav, V and vitamin D level (P>0.05).
measure: Vitamin D Levels
time frame: 12 months
description: The mean D vitamin level was 21.19ng/ml. D vitamin was <20 ng/ml in %55.9 patients. There was no difference in the levels according to the age of all patients.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Because females are more related to low urinary tract symptoms.
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Umraniye Education and Research Hospital
investigator full name: Sibel Ocak Serin
investigator title: Principal investigator
mesh term: Vitamin D Deficiency
mesh term: Lower Urinary Tract Symptoms