xml: <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/NCT05977231</url>
    </required_header>
    <id_info>
      <org_study_id>23MMHIS058e</org_study_id>
      <nct_id>NCT05977231</nct_id>
    </id_info>
    <brief_title>Efficacy of Conservative Treatments for Urinary Incontinence in Women</brief_title>
    <official_title>Evaluation of Efficacy of Conservative Treatments in Women With Urinary Incontinence</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mackay Medical College</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mackay Medical College</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        To conduct a retrospective study to examine the effect of these conservative treatments to&#xD;
        the symptoms and quality of life of patients with urinary incontinence. The investigators&#xD;
        will use both subjective and objective assessment parameters, such as self-report symptoms,&#xD;
        bladder diary, pad test and urodynamic study to access the improvement.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Urinary incontinence is a common problem among women. The main types include stress&#xD;
        incontinence, urge incontinence, and overflow incontinence. Other underlying pathology, such&#xD;
        as cancer or neurologic disease can also cause urinary incontinence. To limit the medical&#xD;
        expenses and possible complications of surgical treatment, the current treatment guidelines&#xD;
        recommend conservative treatment as the first choice. According to American Urological&#xD;
        Association (AUA)/Society of Urodynamics, Female Pelvic Medicine &amp; Urogenital Reconstruction&#xD;
        (SUFU) guidelines, the first-line treatment for non-neurologic overactive bladder should be&#xD;
        behavioral therapy, such as bladder training, water restriction, and pelvic floor muscle&#xD;
        training, physiological feedback, pessary, etc. Bladder training aims to increase the time&#xD;
        interval between voids, and to increase the bladder capacity by self-adjusted schedules.&#xD;
        Pelvic floor muscle training strengthens the pelvic floor muscles to provide urethral support&#xD;
        to prevent urine leakage and suppress urgency. There is strong evidence that pelvic floor&#xD;
        muscle training is beneficial for stress urinary incontinence.&#xD;
  &#xD;
        The second-line treatment is medication, including anticholinergic drugs and ß3&#xD;
        adrenoceptor-acting agents. Anticholinergic drugs can reduce bladder detrusor contraction,&#xD;
        and ß3 adrenoceptor-acting agents can relax the detrusor and increase bladder capacity.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2028</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2023</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>Urodynamic study (intravesical pressure)</measure>
      <time_frame>form the baseline to the post-treatment measurement (about 6 month post)</time_frame>
      <description>intravesical pressure (cmH2O)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Urodynamic study (abdominal pressure)</measure>
      <time_frame>form the baseline to the post-treatment measurement (about 6 month post)</time_frame>
      <description>abdominal pressure (cmH2O)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Urodynamic study (detrusor pressure)</measure>
      <time_frame>from the baseline to the post-treatment measurement (about 6 month post)</time_frame>
      <description>detrusor pressure (cmH2O)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Urodynamic study (Infused volume)</measure>
      <time_frame>from the baseline to the post-treatment measurement (about 6 month post)</time_frame>
      <description>infused volume (ml)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Urodynamic study (voided volume)</measure>
      <time_frame>from the baseline to the post-treatment measurement (about 6 month post)</time_frame>
      <description>voided volume (ml)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pad test</measure>
      <time_frame>from the baseline to the post-treatment measurement (about 6 month post)</time_frame>
      <description>The weight of Pad (g) before and after testing</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Bladder diary (voiding frequency)</measure>
      <time_frame>from the baseline to the post-treatment measurement (about 6 month post)</time_frame>
      <description>the daily voiding frequency (times)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Bladder diary (voiding volume)</measure>
      <time_frame>from the baseline to the post-treatment measurement (about 6 month post)</time_frame>
      <description>the daily voiding volume (ml)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Questionaire (UDI-6)</measure>
      <time_frame>from the baseline to the post-treatment measurement (about 6 month post)</time_frame>
      <description>The urogenital distress inventory-6 (UDI-6)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Questionaire (IIQ-7)</measure>
      <time_frame>from the baseline to the post-treatment measurement (about 6 month post)</time_frame>
      <description>incontinence impact questionnaire-7 (IIQ-7)</description>
    </primary_outcome>
    <number_of_groups>6</number_of_groups>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Urinary Incontinence</condition>
    <arm_group>
      <arm_group_label>Bladder training (BT)</arm_group_label>
      <description>Data obtained before and after the training.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>biofeedback-assisted pelvic floor muscle training (bPFMT)</arm_group_label>
      <description>Data obtained before and after the training.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>intra-vaginal electric stimulation (iVES)</arm_group_label>
      <description>Data obtained before and after the training.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>BT+bPFMT</arm_group_label>
      <description>Data obtained before and after the training.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>BT+iVES</arm_group_label>
      <description>Data obtained before and after the training.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>bPFMT+iVES</arm_group_label>
      <description>Data obtained before and after the training.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>BT</intervention_name>
      <description>A program of BT (including exercise and muscle training)</description>
      <arm_group_label>Bladder training (BT)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>bPFMT</intervention_name>
      <description>A bPFMT program at home</description>
      <arm_group_label>biofeedback-assisted pelvic floor muscle training (bPFMT)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>iVES</intervention_name>
      <description>An iVES program at home</description>
      <arm_group_label>intra-vaginal electric stimulation (iVES)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>BT + bPFMT</intervention_name>
      <description>Combination of BT and bPFMT</description>
      <arm_group_label>BT+bPFMT</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>BT + iVES</intervention_name>
      <description>Combination of BT and iVES</description>
      <arm_group_label>BT+iVES</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>bPFMT + iVES</intervention_name>
      <description>Combination of bPFMT and iVES</description>
      <arm_group_label>bPFMT+iVES</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Diagnosed at Mackay Memorial Hospital, the adult female patient was clinically assessed and&#xD;
          diagnosed with urinary incontinence. Non-surgical treatments were administered, followed by&#xD;
          subsequent monitoring and follow-up.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adult female patient diagnosed with urinary incontinence through clinical assessment&#xD;
  &#xD;
            -  Diagnosed at Mackay Memorial Hospital and underwent non-surgical treatment and&#xD;
               subsequent follow-up.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Choosing invasive or surgical treatment options (such as bladder botulinum toxin&#xD;
               injection, urethral sling surgery).&#xD;
  &#xD;
            -  Unable to comply with regular follow-up for at least one year.&#xD;
  &#xD;
            -  Pregnant women&#xD;
  &#xD;
            -  Patients with a history of neuromuscular disorders.&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>20 Years</minimum_age>
      <maximum_age>100 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Hui-Hsuan Lau, M.D.</last_name>
      <role>Study Chair</role>
      <affiliation>Department of Ear, Nose, and Throat, MacKay Memorial Hospital, Taipei, Taiwan</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Hui-Hsuan Lau, M.D.</last_name>
      <phone>+886-975-835928</phone>
      <email>huihsuan1220@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Department of Obstetrics and Gynecology</name>
        <address>
          <city>New Taipei City</city>
          <country>Taiwan</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Hui-Hsuan Lau, PhD</last_name>
        <phone>+886 975-835928</phone>
        <email>huihsuan1220@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Taiwan</country>
    </location_countries>
    <reference>
      <citation>Denisenko AA, Clark CB, D'Amico M, Murphy AM. Evaluation and management of female urinary incontinence. Can J Urol. 2021 Aug;28(S2):27-32.</citation>
      <PMID>34453426</PMID>
    </reference>
    <reference>
      <citation>Wallace SL, Miller LD, Mishra K. Pelvic floor physical therapy in the treatment of pelvic floor dysfunction in women. Curr Opin Obstet Gynecol. 2019 Dec;31(6):485-493. doi: 10.1097/GCO.0000000000000584.</citation>
      <PMID>31609735</PMID>
    </reference>
    <reference>
      <citation>Aoki Y, Brown HW, Brubaker L, Cornu JN, Daly JO, Cartwright R. Urinary incontinence in women. Nat Rev Dis Primers. 2017 Jul 6;3:17042. doi: 10.1038/nrdp.2017.42. Erratum In: Nat Rev Dis Primers. 2017 Nov 16;3:17097.</citation>
      <PMID>28681849</PMID>
    </reference>
    <reference>
      <citation>Lin HY, Tsai HW, Tsui KH, An YF, Lo CC, Lin ZH, Liou WS, Wang PH. The short-term outcome of laser in the management of female pelvic floor disorders: Focus on stress urine incontinence and sexual dysfunction. Taiwan J Obstet Gynecol. 2018 Dec;57(6):825-829. doi: 10.1016/j.tjog.2018.10.010.</citation>
      <PMID>30545535</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 13, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 4, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 4, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mackay Medical College</investigator_affiliation>
      <investigator_full_name>Chin-Tsung Shen</investigator_full_name>
      <investigator_title>The Office of Research and Development staff</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>For we uncertain if this might violate personal information laws in our country.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05977231
  org study id: 23MMHIS058e
  nct id: NCT05977231
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  To conduct a retrospective study to examine the effect of these conservative treatments to
        the symptoms and quality of life of patients with urinary incontinence. The investigators
        will use both subjective and objective assessment parameters, such as self-report symptoms,
        bladder diary, pad test and urodynamic study to access the improvement.
  Urinary incontinence is a common problem among women. The main types include stress
        incontinence, urge incontinence, and overflow incontinence. Other underlying pathology, such
        as cancer or neurologic disease can also cause urinary incontinence. To limit the medical
        expenses and possible complications of surgical treatment, the current treatment guidelines
        recommend conservative treatment as the first choice. According to American Urological
        Association (AUA)/Society of Urodynamics, Female Pelvic Medicine & Urogenital Reconstruction
        (SUFU) guidelines, the first-line treatment for non-neurologic overactive bladder should be
        behavioral therapy, such as bladder training, water restriction, and pelvic floor muscle
        training, physiological feedback, pessary, etc. Bladder training aims to increase the time
        interval between voids, and to increase the bladder capacity by self-adjusted schedules.
        Pelvic floor muscle training strengthens the pelvic floor muscles to provide urethral support
        to prevent urine leakage and suppress urgency. There is strong evidence that pelvic floor
        muscle training is beneficial for stress urinary incontinence.
  
        The second-line treatment is medication, including anticholinergic drugs and ß3
        adrenoceptor-acting agents. Anticholinergic drugs can reduce bladder detrusor contraction,
        and ß3 adrenoceptor-acting agents can relax the detrusor and increase bladder capacity.
  observational model: Cohort
  time perspective: Retrospective
  measure: Urodynamic study (intravesical pressure)
  time frame: form the baseline to the post-treatment measurement (about 6 month post)
  description: intravesical pressure (cmH2O)
  measure: Urodynamic study (abdominal pressure)
  time frame: form the baseline to the post-treatment measurement (about 6 month post)
  description: abdominal pressure (cmH2O)
  measure: Urodynamic study (detrusor pressure)
  time frame: from the baseline to the post-treatment measurement (about 6 month post)
  description: detrusor pressure (cmH2O)
  measure: Urodynamic study (Infused volume)
  time frame: from the baseline to the post-treatment measurement (about 6 month post)
  description: infused volume (ml)
  measure: Urodynamic study (voided volume)
  time frame: from the baseline to the post-treatment measurement (about 6 month post)
  description: voided volume (ml)
  measure: Pad test
  time frame: from the baseline to the post-treatment measurement (about 6 month post)
  description: The weight of Pad (g) before and after testing
  measure: Bladder diary (voiding frequency)
  time frame: from the baseline to the post-treatment measurement (about 6 month post)
  description: the daily voiding frequency (times)
  measure: Bladder diary (voiding volume)
  time frame: from the baseline to the post-treatment measurement (about 6 month post)
  description: the daily voiding volume (ml)
  measure: Questionaire (UDI-6)
  time frame: from the baseline to the post-treatment measurement (about 6 month post)
  description: The urogenital distress inventory-6 (UDI-6)
  measure: Questionaire (IIQ-7)
  time frame: from the baseline to the post-treatment measurement (about 6 month post)
  description: incontinence impact questionnaire-7 (IIQ-7)
  arm group label: Bladder training (BT)
  description: Data obtained before and after the training.
  arm group label: biofeedback-assisted pelvic floor muscle training (bPFMT)
  description: Data obtained before and after the training.
  arm group label: intra-vaginal electric stimulation (iVES)
  description: Data obtained before and after the training.
  arm group label: BT+bPFMT
  description: Data obtained before and after the training.
  arm group label: BT+iVES
  description: Data obtained before and after the training.
  arm group label: bPFMT+iVES
  description: Data obtained before and after the training.
  intervention type: Procedure
  intervention name: BT
  description: A program of BT (including exercise and muscle training)
  arm group label: Bladder training (BT)
  intervention type: Procedure
  intervention name: bPFMT
  description: A bPFMT program at home
  arm group label: biofeedback-assisted pelvic floor muscle training (bPFMT)
  intervention type: Procedure
  intervention name: iVES
  description: An iVES program at home
  arm group label: intra-vaginal electric stimulation (iVES)
  intervention type: Procedure
  intervention name: BT + bPFMT
  description: Combination of BT and bPFMT
  arm group label: BT+bPFMT
  intervention type: Procedure
  intervention name: BT + iVES
  description: Combination of BT and iVES
  arm group label: BT+iVES
  intervention type: Procedure
  intervention name: bPFMT + iVES
  description: Combination of bPFMT and iVES
  arm group label: bPFMT+iVES
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: Female
  minimum age: 20 Years
  maximum age: 100 Years
  healthy volunteers: No
  last name: Hui-Hsuan Lau, M.D.
  role: Study Chair
  affiliation: Department of Ear, Nose, and Throat, MacKay Memorial Hospital, Taipei, Taiwan
  last name: Hui-Hsuan Lau, M.D.
  phone: +886-975-835928
  email: huihsuan1220@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Taiwan
  citation: Denisenko AA, Clark CB, D'Amico M, Murphy AM. Evaluation and management of female urinary incontinence. Can J Urol. 2021 Aug;28(S2):27-32.
  PMID: 34453426
  citation: Wallace SL, Miller LD, Mishra K. Pelvic floor physical therapy in the treatment of pelvic floor dysfunction in women. Curr Opin Obstet Gynecol. 2019 Dec;31(6):485-493. doi: 10.1097/GCO.0000000000000584.
  PMID: 31609735
  citation: Aoki Y, Brown HW, Brubaker L, Cornu JN, Daly JO, Cartwright R. Urinary incontinence in women. Nat Rev Dis Primers. 2017 Jul 6;3:17042. doi: 10.1038/nrdp.2017.42. Erratum In: Nat Rev Dis Primers. 2017 Nov 16;3:17097.
  PMID: 28681849
  citation: Lin HY, Tsai HW, Tsui KH, An YF, Lo CC, Lin ZH, Liou WS, Wang PH. The short-term outcome of laser in the management of female pelvic floor disorders: Focus on stress urine incontinence and sexual dysfunction. Taiwan J Obstet Gynecol. 2018 Dec;57(6):825-829. doi: 10.1016/j.tjog.2018.10.010.
  PMID: 30545535
  responsible party type: Principal Investigator
  investigator affiliation: Mackay Medical College
  investigator full name: Chin-Tsung Shen
  investigator title: The Office of Research and Development staff
  mesh term: Urinary Incontinence
  mesh term: Enuresis
  sharing ipd: No
  ipd description: For we uncertain if this might violate personal information laws in our country.