<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/NCT04470700</url>
  </required_header>
  <id_info>
    <org_study_id>711/RC/KEMU</org_study_id>
    <nct_id>NCT04470700</nct_id>
  </id_info>
  <brief_title>Predictors of Delay in Treatment of Urinary Incontinence</brief_title>
  <acronym>Predictors</acronym>
  <official_title>Predictors of Delay in Treatment of Urinary Incontinence Among Pakistani Women - a Cross-sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shazia Saaqib</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Edward Medical University</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>
      246 women were selected as participants to fill and submit the Study Proforma among 264&#xD;
      incontinent women. The Performa included demographic features of the subjects, their chronic&#xD;
      ailments, psychosocial effects, reasons for the delay, and Incontinence Questionnaire&#xD;
      UI-short form of incontinence characteristics. We selected a sample of 198 completed&#xD;
      questionnaires to be included in the study. IBM spss statistics 20(SPSS Inc, Chicago, IL,&#xD;
      USA) were used to find predictors of delay in treating urinary incontinence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design and participants:&#xD;
&#xD;
      A cross-sectional survey of 198 women with incontinence was conducted at lady Willingdon&#xD;
      hospital from June 1, 2019, to November 30, 2020. The medical officers of gynecology outdoor&#xD;
      scrutinized all the women who had complained of urinary incontinence for at least one year&#xD;
      and did not previously pursue any treatment for this problem.&#xD;
&#xD;
      246 participants who fulfilled the study criteria signed written informed consent and got&#xD;
      their Proforma filled either by themselves or by assisting the medical officer.&#xD;
&#xD;
      In previous studies, delay to the treatment of &gt;3 years was considered significant; thus, all&#xD;
      eligible women were divided into two groups based on the delay of up to three years and more&#xD;
      than 3 years according to the duration of incontinence as stated by the subject and studied&#xD;
      for predictors of incontinence.&#xD;
&#xD;
      Ethical approval This study had ethical approval from King Edward Medical University,&#xD;
      Pakistan. the study was conducted according to the Declaration of the Helsinki and obtained&#xD;
      informed consent from participants before the study commenced. All information collected from&#xD;
      the participants was kept confidential, and Proformas were kept in a file in the custody of&#xD;
      the main investigator after entering data in the spss datasheet.&#xD;
&#xD;
      Statistical analysis. The study results were calculated with SPSS version 20 (SPSS Inc.,&#xD;
      Chicago, IL, USA). The means and standard deviation were used to calculate the age of&#xD;
      subjects and the duration of delay in seeking treatment. The subjects with potential risk&#xD;
      factors were represented as numbers and percentages. The subjects with a short delay(less&#xD;
      than or equal to three years) and a long delay (greater than three years) were presented as&#xD;
      numbers and percentages for reporting their incontinence. Univariate analysis was performed&#xD;
      on all risk factors of delay and then multivariate analysis on significant risk factors to&#xD;
      determine the most commonly shared factors for delay in seeking treatment. P-value ≤ 0.05 was&#xD;
      considered statistically significant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2019</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</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>Predictors of delay in treatment of urinary incontinence</measure>
    <time_frame>6months from1st june2019 to 30 november 2019</time_frame>
    <description>the risk factors of incontinence treatment delay wich are shared by the women with delayed help seeking behaviour</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">298</enrollment>
  <condition>Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>subjects with greater than 3years delay</arm_group_label>
    <description>Subjects with delay in treatment of Urinary incontinence greater than three years</description>
  </arm_group>
  <arm_group>
    <arm_group_label>subjects with less than three years delay</arm_group_label>
    <description>Subjects with delay in treatment of Urinary incontinence lesser than three years</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The women who had complained of urinary incontinence for at least one year and did not&#xD;
        pursue any treatment for this problem previously.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The women who had the complaint of urinary incontinence for at least one year and did&#xD;
             not pursue any treatment for this problem previously.&#xD;
&#xD;
          -  age greater than 18 years&#xD;
&#xD;
          -  urinary leakage for once a week during the previous three months.&#xD;
&#xD;
          -  Incontinent women with or without chronic medical problems&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  urinary tract infection&#xD;
&#xD;
          -  patients with pregnancy or within three months postpartum&#xD;
&#xD;
          -  severe mental illness (unable to answer the questionnaire correctly)&#xD;
&#xD;
          -  terminal stage illness (liver disease, kidney disease, or malignancy)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Female subjects above18 years of age</gender_description>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Shazia Saaqib, FCPS,MCPS</last_name>
    <role>Study Chair</role>
    <affiliation>King Edward Medical University,Lahore, Pakistan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Lady Willingdon Hospital</name>
      <address>
        <city>Lahore</city>
        <state>Punjab</state>
        <zip>042</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <link>
    <url>https://doi.org/10.1007/s001920050038</url>
    <description>The Prevalence and Determinants of Health Care-Seeking Behavior for Urinary Incontinence in United Arab Emirates Women</description>
  </link>
  <link>
    <url>https://doi.org/10.1007/s13670-017-0202-4</url>
    <description>The Relationship Between Urinary Incontinence, Mobility Limitations, and Disability in Older Women</description>
  </link>
  <results_reference>
    <citation>Sensoy N, Dogan N, Ozek B, Karaaslan L. Urinary incontinence in women: prevalence rates, risk factors and impact on quality of life. Pak J Med Sci. 2013 May;29(3):818-22. doi: 10.12669/pjms.293.3404.</citation>
    <PMID>24353635</PMID>
  </results_reference>
  <results_reference>
    <citation>Norton PA, MacDonald LD, Sedgwick PM, Stanton SL. Distress and delay associated with urinary incontinence, frequency, and urgency in women. BMJ. 1988 Nov 5;297(6657):1187-9. doi: 10.1136/bmj.297.6657.1187. No abstract available.</citation>
    <PMID>3144344</PMID>
  </results_reference>
  <results_reference>
    <citation>Corcos J, Gajewski J, Heritz D, Patrick A, Reid I, Schick E, Stothers L; Canadian Urological Association. Canadian Urological Association guidelines on urinary incontinence. Can J Urol. 2006 Jun;13(3):3127-38.</citation>
    <PMID>16813704</PMID>
  </results_reference>
  <results_reference>
    <citation>Lasserre A, Pelat C, Gueroult V, Hanslik T, Chartier-Kastler E, Blanchon T, Ciofu C, Montefiore ED, Alvarez FP, Bloch J. Urinary incontinence in French women: prevalence, risk factors, and impact on quality of life. Eur Urol. 2009 Jul;56(1):177-83. doi: 10.1016/j.eururo.2009.04.006. Epub 2009 Apr 10.</citation>
    <PMID>19376639</PMID>
  </results_reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 14, 2020</study_first_posted>
  <last_update_submitted>July 14, 2021</last_update_submitted>
  <last_update_submitted_qc>July 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>King Edward Medical University</investigator_affiliation>
    <investigator_full_name>Shazia Saaqib</investigator_full_name>
    <investigator_title>Assistant Professor Obstetrics and Gynecology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>The data will be shared after publication on a reasonable request.</ipd_description>
  </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/NCT04470700
org study id: 711/RC/KEMU
nct id: NCT04470700
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
246 women were selected as participants to fill and submit the Study Proforma among 264
      incontinent women. The Performa included demographic features of the subjects, their chronic
      ailments, psychosocial effects, reasons for the delay, and Incontinence Questionnaire
      UI-short form of incontinence characteristics. We selected a sample of 198 completed
      questionnaires to be included in the study. IBM spss statistics 20(SPSS Inc, Chicago, IL,
      USA) were used to find predictors of delay in treating urinary incontinence.
Study design and participants:

      A cross-sectional survey of 198 women with incontinence was conducted at lady Willingdon
      hospital from June 1, 2019, to November 30, 2020. The medical officers of gynecology outdoor
      scrutinized all the women who had complained of urinary incontinence for at least one year
      and did not previously pursue any treatment for this problem.

      246 participants who fulfilled the study criteria signed written informed consent and got
      their Proforma filled either by themselves or by assisting the medical officer.

      In previous studies, delay to the treatment of >3 years was considered significant; thus, all
      eligible women were divided into two groups based on the delay of up to three years and more
      than 3 years according to the duration of incontinence as stated by the subject and studied
      for predictors of incontinence.

      Ethical approval This study had ethical approval from King Edward Medical University,
      Pakistan. the study was conducted according to the Declaration of the Helsinki and obtained
      informed consent from participants before the study commenced. All information collected from
      the participants was kept confidential, and Proformas were kept in a file in the custody of
      the main investigator after entering data in the spss datasheet.

      Statistical analysis. The study results were calculated with SPSS version 20 (SPSS Inc.,
      Chicago, IL, USA). The means and standard deviation were used to calculate the age of
      subjects and the duration of delay in seeking treatment. The subjects with potential risk
      factors were represented as numbers and percentages. The subjects with a short delay(less
      than or equal to three years) and a long delay (greater than three years) were presented as
      numbers and percentages for reporting their incontinence. Univariate analysis was performed
      on all risk factors of delay and then multivariate analysis on significant risk factors to
      determine the most commonly shared factors for delay in seeking treatment. P-value ≤ 0.05 was
      considered statistically significant.
observational model: Cohort
time perspective: Prospective
measure: Predictors of delay in treatment of urinary incontinence
time frame: 6months from1st june2019 to 30 november 2019
description: the risk factors of incontinence treatment delay wich are shared by the women with delayed help seeking behaviour
arm group label: subjects with greater than 3years delay
description: Subjects with delay in treatment of Urinary incontinence greater than three years
arm group label: subjects with less than three years delay
description: Subjects with delay in treatment of Urinary incontinence lesser than three years
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: Female subjects above18 years of age
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Shazia Saaqib, FCPS,MCPS
role: Study Chair
affiliation: King Edward Medical University,Lahore, Pakistan
facility: 
country: Pakistan
url: https://doi.org/10.1007/s001920050038
description: The Prevalence and Determinants of Health Care-Seeking Behavior for Urinary Incontinence in United Arab Emirates Women
url: https://doi.org/10.1007/s13670-017-0202-4
description: The Relationship Between Urinary Incontinence, Mobility Limitations, and Disability in Older Women
citation: Sensoy N, Dogan N, Ozek B, Karaaslan L. Urinary incontinence in women: prevalence rates, risk factors and impact on quality of life. Pak J Med Sci. 2013 May;29(3):818-22. doi: 10.12669/pjms.293.3404.
PMID: 24353635
citation: Norton PA, MacDonald LD, Sedgwick PM, Stanton SL. Distress and delay associated with urinary incontinence, frequency, and urgency in women. BMJ. 1988 Nov 5;297(6657):1187-9. doi: 10.1136/bmj.297.6657.1187. No abstract available.
PMID: 3144344
citation: Corcos J, Gajewski J, Heritz D, Patrick A, Reid I, Schick E, Stothers L; Canadian Urological Association. Canadian Urological Association guidelines on urinary incontinence. Can J Urol. 2006 Jun;13(3):3127-38.
PMID: 16813704
citation: Lasserre A, Pelat C, Gueroult V, Hanslik T, Chartier-Kastler E, Blanchon T, Ciofu C, Montefiore ED, Alvarez FP, Bloch J. Urinary incontinence in French women: prevalence, risk factors, and impact on quality of life. Eur Urol. 2009 Jul;56(1):177-83. doi: 10.1016/j.eururo.2009.04.006. Epub 2009 Apr 10.
PMID: 19376639
responsible party type: Sponsor-Investigator
investigator affiliation: King Edward Medical University
investigator full name: Shazia Saaqib
investigator title: Assistant Professor Obstetrics and Gynecology
mesh term: Urinary Incontinence
mesh term: Enuresis
sharing ipd: No
ipd description: The data will be shared after publication on a reasonable request.