<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/NCT02185287</url>
  </required_header>
  <id_info>
    <org_study_id>2199/13 Prot.N.1625/13/ON</org_study_id>
    <nct_id>NCT02185287</nct_id>
  </id_info>
  <brief_title>&quot;The Urological Dysfunctions in Young Women: Inheritance of Childhood?&quot;</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Roma La Sapienza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Of Perugia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Roma La Sapienza</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim of the study protocol is to evaluate in a prospective investigation of health statistics&#xD;
      if the dysfunctions of the lower urinary tract in women aged between 18 and 40 years may be&#xD;
      the result of past urinary pediatric dysfunction. The aim is to be able to identify the &quot;risk&#xD;
      conditions&quot; which, if treated properly in early childhood, to help avoid debilitating&#xD;
      problems that manifest themselves as adults and possibly to implement a strategy of&#xD;
      prevention.&#xD;
&#xD;
      The choice of this age group is due to the fact that it allows for easier retrieval of data,&#xD;
      as it is presumed that the concerned can more easily remember their history of pediatric and&#xD;
      / or have parents still young enough to ask for such information. The problems of urinary&#xD;
      disorders in childhood era have been the subject of increased attention by pediatricians from&#xD;
      the end of the 70s, therefore, history taking may be more complete.&#xD;
&#xD;
      A study by Fitzgerald evaluated female subjects with mean age of 56 ± 9 years, and therefore&#xD;
      our study aim is to investigate an age group that does not appear in the literature to&#xD;
      supplement these findings, already reported.&#xD;
&#xD;
      Ultimate goal is the need to raise awareness of Pediatric Urologists to interact with adult&#xD;
      Urologists in order to implement a shared strategy for the management of patients with&#xD;
      problems of impaired bladder function in order to improve the future lower urinary tract&#xD;
      function.&#xD;
&#xD;
      Materials and Methods: A self administered questionnaire will be used in accordance with the&#xD;
      guidelines of the International Children's Continence Society. The questionnaire consists of&#xD;
      two parts: the first explores the history of urological clinic patient until the age of 14,in&#xD;
      order to evaluate any symptoms reported in a specific category of typical dysfunction of&#xD;
      childhood; the second part refers to the present together with urological disorders of sexual&#xD;
      function which, as emerges from the data of the literature may be of relevance urological&#xD;
      diseases detectors. The data obtained will then be subjected to statistical calculations by&#xD;
      which will evaluate the significance of the symptoms present in childhood in relation to&#xD;
      their penetrance in various forms of adult diseases dysfunctional bladder and / or sexual&#xD;
      abuse, with the prediction of the evolution of the same.&#xD;
&#xD;
      The questionnaire is anonymous in order to protect privacy. The questions that comprise it&#xD;
      have been partly extracted from the questionnaire validated by the International Children's&#xD;
      Society Continent and partly made by the authors of this study on the basis of the scientific&#xD;
      evidence.&#xD;
&#xD;
      Patients will be recruited from the outpatient clinic of the Urogynecology Urology Clinic,&#xD;
      University of Perugia, while the healthy controls will be recruited by submitting a&#xD;
      questionnaire to the women chosen to sample a healthy population of Graduate Schools found in&#xD;
      the framework of Urology, Pediatrics and Pediatric Surgery, University of Perugia.&#xD;
&#xD;
      The Investigators defined that the statistically significant number of healthy and&#xD;
      pathological subjects can not be less than 200 units per reference category.&#xD;
&#xD;
      The time duration of the collection of anamnestic data depend on the ability of the authors&#xD;
      of this research in finding the subjects to be analyzed.&#xD;
&#xD;
      There are no conflicts of interest to declare, no drugs or medical equipment will be tested .&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2013</start_date>
  <completion_date type="Anticipated">March 2016</completion_date>
  <primary_completion_date type="Actual">December 2014</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>International Children Continence Society Questionnaire</measure>
    <time_frame>Questionnaires scores at time 0 (screening time)</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Lower Urinary Tract Dysfunction</condition>
  <arm_group>
    <arm_group_label>Lower urinary tract dysfunction, female, age: 18-40 years</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy female subjects, age: 18-40 years</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients will be recruited from the outpatient clinic of the Urogynecology Urology Clinic,&#xD;
        University of Perugia, while the healthy controls will be recruited by submitting a&#xD;
        questionnaire to the women chosen to sample a healthy population of Graduate Schools found&#xD;
        in the framework of Urology, Pediatrics and Pediatric Surgery, University of Perugia.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Any lower urinary tract symptoms&#xD;
&#xD;
          -  Female aged between 18 and 40 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age limit&#xD;
&#xD;
          -  Lower urinary tract infection&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Elisabetta Costantini, Associate Professor</last_name>
    <email>elisabetta.costantini@unipg.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>Urology Unit, Sapienza University of Rome</name>
      <address>
        <city>Latina</city>
        <zip>04100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Pediatric Surgery, University of Perugia</name>
      <address>
        <city>Perugia</city>
        <zip>06131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marco Prestipino, MD</last_name>
      <email>marco.prestipino@unipg.it</email>
    </contact>
    <investigator>
      <last_name>Antonino Appignani, Professor, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Marco Prestipino, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Urogynecology Unit, Urology Clinic, University of Perugia</name>
      <address>
        <city>Perugia</city>
        <zip>06131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Elisabetta Costantini, Associate Professor</last_name>
      <phone>+390755783743</phone>
      <email>elisabetta.costantini@unipg.it</email>
    </contact>
    <investigator>
      <last_name>Elisabetta Costantini, MD, Associate Professor</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Eleonora Salvini, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Kuh D, Cardozo L, Hardy R. Urinary incontinence in middle aged women: childhood enuresis and other lifetime risk factors in a British prospective cohort. J Epidemiol Community Health. 1999 Aug;53(8):453-8. doi: 10.1136/jech.53.8.453.</citation>
    <PMID>10562862</PMID>
  </reference>
  <reference>
    <citation>Fitzgerald MP, Thom DH, Wassel-Fyr C, Subak L, Brubaker L, Van Den Eeden SK, Brown JS; Reproductive Risks for Incontinence Study at Kaiser Research Group. Childhood urinary symptoms predict adult overactive bladder symptoms. J Urol. 2006 Mar;175(3 Pt 1):989-93. doi: 10.1016/S0022-5347(05)00416-7.</citation>
    <PMID>16469599</PMID>
  </reference>
  <reference>
    <citation>Falconer C, Ekman-Ordeberg G, Hilliges M, Johansson O. Decreased innervation of the paraurethral epithelium in stress urinary incontinent women. Eur J Obstet Gynecol Reprod Biol. 1997 Apr;72(2):195-8. doi: 10.1016/s0301-2115(96)02685-1.</citation>
    <PMID>9134401</PMID>
  </reference>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>July 1, 2014</study_first_submitted>
  <study_first_submitted_qc>July 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>May 27, 2015</last_update_submitted>
  <last_update_submitted_qc>May 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Roma La Sapienza</investigator_affiliation>
    <investigator_full_name>Antonio Luigi Pastore</investigator_full_name>
    <investigator_title>Assistant Professor, MD, PhD</investigator_title>
  </responsible_party>
  <pending_results>
    <submitted>August 6, 2017</submitted>
    <submission_canceled>Unknown</submission_canceled>
    <submitted>January 28, 2018</submitted>
    <returned>September 21, 2018</returned>
  </pending_results>
  <!-- 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/NCT02185287
org study id: 2199/13 Prot.N.1625/13/ON
nct id: NCT02185287
lead sponsor: 
collaborator: 
has dmc: No
Aim of the study protocol is to evaluate in a prospective investigation of health statistics
      if the dysfunctions of the lower urinary tract in women aged between 18 and 40 years may be
      the result of past urinary pediatric dysfunction. The aim is to be able to identify the "risk
      conditions" which, if treated properly in early childhood, to help avoid debilitating
      problems that manifest themselves as adults and possibly to implement a strategy of
      prevention.

      The choice of this age group is due to the fact that it allows for easier retrieval of data,
      as it is presumed that the concerned can more easily remember their history of pediatric and
      / or have parents still young enough to ask for such information. The problems of urinary
      disorders in childhood era have been the subject of increased attention by pediatricians from
      the end of the 70s, therefore, history taking may be more complete.

      A study by Fitzgerald evaluated female subjects with mean age of 56 ± 9 years, and therefore
      our study aim is to investigate an age group that does not appear in the literature to
      supplement these findings, already reported.

      Ultimate goal is the need to raise awareness of Pediatric Urologists to interact with adult
      Urologists in order to implement a shared strategy for the management of patients with
      problems of impaired bladder function in order to improve the future lower urinary tract
      function.

      Materials and Methods: A self administered questionnaire will be used in accordance with the
      guidelines of the International Children's Continence Society. The questionnaire consists of
      two parts: the first explores the history of urological clinic patient until the age of 14,in
      order to evaluate any symptoms reported in a specific category of typical dysfunction of
      childhood; the second part refers to the present together with urological disorders of sexual
      function which, as emerges from the data of the literature may be of relevance urological
      diseases detectors. The data obtained will then be subjected to statistical calculations by
      which will evaluate the significance of the symptoms present in childhood in relation to
      their penetrance in various forms of adult diseases dysfunctional bladder and / or sexual
      abuse, with the prediction of the evolution of the same.

      The questionnaire is anonymous in order to protect privacy. The questions that comprise it
      have been partly extracted from the questionnaire validated by the International Children's
      Society Continent and partly made by the authors of this study on the basis of the scientific
      evidence.

      Patients will be recruited from the outpatient clinic of the Urogynecology Urology Clinic,
      University of Perugia, while the healthy controls will be recruited by submitting a
      questionnaire to the women chosen to sample a healthy population of Graduate Schools found in
      the framework of Urology, Pediatrics and Pediatric Surgery, University of Perugia.

      The Investigators defined that the statistically significant number of healthy and
      pathological subjects can not be less than 200 units per reference category.

      The time duration of the collection of anamnestic data depend on the ability of the authors
      of this research in finding the subjects to be analyzed.

      There are no conflicts of interest to declare, no drugs or medical equipment will be tested .
observational model: Case-Control
time perspective: Prospective
measure: International Children Continence Society Questionnaire
time frame: Questionnaires scores at time 0 (screening time)
arm group label: Lower urinary tract dysfunction, female, age: 18-40 years
arm group label: Healthy female subjects, age: 18-40 years
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Elisabetta Costantini, Associate Professor
email: elisabetta.costantini@unipg.it
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Italy
citation: Kuh D, Cardozo L, Hardy R. Urinary incontinence in middle aged women: childhood enuresis and other lifetime risk factors in a British prospective cohort. J Epidemiol Community Health. 1999 Aug;53(8):453-8. doi: 10.1136/jech.53.8.453.
PMID: 10562862
citation: Fitzgerald MP, Thom DH, Wassel-Fyr C, Subak L, Brubaker L, Van Den Eeden SK, Brown JS; Reproductive Risks for Incontinence Study at Kaiser Research Group. Childhood urinary symptoms predict adult overactive bladder symptoms. J Urol. 2006 Mar;175(3 Pt 1):989-93. doi: 10.1016/S0022-5347(05)00416-7.
PMID: 16469599
citation: Falconer C, Ekman-Ordeberg G, Hilliges M, Johansson O. Decreased innervation of the paraurethral epithelium in stress urinary incontinent women. Eur J Obstet Gynecol Reprod Biol. 1997 Apr;72(2):195-8. doi: 10.1016/s0301-2115(96)02685-1.
PMID: 9134401
responsible party type: Principal Investigator
investigator affiliation: University of Roma La Sapienza
investigator full name: Antonio Luigi Pastore
investigator title: Assistant Professor, MD, PhD
submitted: August 6, 2017
submission canceled: Unknown
submitted: January 28, 2018
returned: September 21, 2018