<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/NCT02238678</url>
  </required_header>
  <id_info>
    <org_study_id>ENDOBLAD 1057/2014</org_study_id>
    <nct_id>NCT02238678</nct_id>
  </id_info>
  <brief_title>Impact of Deep Endometriosis Surgery on Bladder Function</brief_title>
  <official_title>Impact of Deep Endometriosis Surgery on Bladder Function</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Vienna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Department of Obstetrics and Gynaecology, Insubria Unievrsity, Varese (Italy)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University of Vienna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      It has been demonstrated that ligaments, both cardinal and uterosacral contain a considerable&#xD;
      amount of autonomic nerve tissues. The resection of deep infiltrating endometriotic nodules&#xD;
      at the level of the uterosacral ligaments or the rectovaginal space is supposed to damage the&#xD;
      supplying autonomic nerve fibers of the lower urinary tract. The bladder receives motor and&#xD;
      sensitive innervations from both the sympathetic fibers, most of which arise from the&#xD;
      hypogastric plexuses and nerves, and the parasympathetic fibers, which arise from the pelvic&#xD;
      splanchnic nerves and the inferior hypogastric plexus; therefore, even bladder function may&#xD;
      be impaired in women affected by deep endometriosis.&#xD;
&#xD;
      Very few data have been published regarding the urodynamic functional evaluation of bladder&#xD;
      in patient with deep endometriosis.So far, it is unknown if the surgery itself causes the&#xD;
      postoperative bladder dysfunction or if the surgery unmasks a subclinically pre-existing&#xD;
      detrusor pathology.&#xD;
&#xD;
      Since the urinary postoperative complications have a strong impact on quality of life of the&#xD;
      deep endometriosis patients and often requires management (due to a poor spontaneous&#xD;
      remission), it is crucial a better understanding of the problem. That will help for a more&#xD;
      appropriate pre-operative counselling.&#xD;
&#xD;
      Aims of this study are to evaluate the bladder function before and after deep endometriosis&#xD;
      surgery, using standardized validated instruments and to correlate the localisation of the&#xD;
      endometriosis lesion, the type/area of surgical dissection with the postoperative bladder&#xD;
      function.&#xD;
&#xD;
      This is a prospective multicenter cohort study involving the Department of General&#xD;
      Gynaecology and Gynecological Oncology of Medical University of Vienna (Austria) and the&#xD;
      Department of Obstetrics and Gynaecology of Insubria University, Varese (Italy).&#xD;
&#xD;
      A total of 50 patients are planned to be included. The study protocol consider a Preoperative&#xD;
      Assessment (clinical examination, transvaginal pelvic ultrasound, preoperative specific&#xD;
      questionnaire including obstetric, medical, and surgical history and standardized questions&#xD;
      on pelvic floor dysfunctions, standardized instrumental assessment of the pelvic floor) a&#xD;
      Intraoperative Assessment (during laparoscopy, the localizations of endometriotic lesions&#xD;
      recorded and identified by anatomical sites, numbers, and depth of infiltration). Before and&#xD;
      3 months after surgery a Urodynamic assessment is planned.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>June 2014</start_date>
  <primary_completion_date type="Actual">June 2014</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>Urodynamic assessment after deep infiltrating endometriosis surgery</measure>
    <time_frame>2 years</time_frame>
    <description>to evaluate the bladder function before and after deep endometriosis surgery (Unit of Measure: First Desire (ml) from Urodynamic Assessment)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Bladder symptoms after surgery for deep infiltrating endometriosis</measure>
    <time_frame>2 years</time_frame>
    <description>using standardized validated questionnaires -OABQ short form, ICIQ short form questionnaire, micturition diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>correlation between localisation of the endometriosis lesion and postoperative bladder function.</measure>
    <time_frame>2 years</time_frame>
    <description>to correlate the localisation of the endometriosis lesion, the type/area of surgical dissection with a specific urodynamic pattern and/or a specific low urinary tract symptom</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Deep Infiltrating Endometriosis</condition>
  <arm_group>
    <arm_group_label>Deep endometriosis patients</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        - Patients with confirmed diagnosis of deep infiltrating endometriosis requiring surgical&#xD;
        treatment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with confirmed diagnosis of deep infiltrating endometriosis requiring&#xD;
             surgical treatment&#xD;
&#xD;
          -  Patient planned to be submitted to laparoscopic surgery finalize to eradicate the&#xD;
             endometriosis pathology&#xD;
&#xD;
          -  Naïve patients for OAB treatment.&#xD;
&#xD;
          -  Patients must be capable of independent toileting&#xD;
&#xD;
          -  Patients must be able to fully understand all study procedures and to provide written&#xD;
             informed consent to study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient previously submitted to pelvic surgery for any urogynaecological disease;&#xD;
&#xD;
          -  Patients previously submitted to DE surgery&#xD;
&#xD;
          -  Patient with documented clinical, instrumental, or laparoscopic preoperative diagnosis&#xD;
             of bladder endometriosis;&#xD;
&#xD;
          -  Patient with documented urinary tract infection&#xD;
&#xD;
          -  Patient with history of diabetes mellitus, psychiatric, or neurological disease;&#xD;
&#xD;
          -  Pregnant patients&#xD;
&#xD;
          -  Patients &lt; 18 years&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 10, 2014</last_update_submitted>
  <last_update_submitted_qc>September 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
    <investigator_full_name>Laterza Rosa Maria</investigator_full_name>
    <investigator_title>Dr. med</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Endometriosis</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/NCT02238678
org study id: ENDOBLAD 1057/2014
nct id: NCT02238678
lead sponsor: 
collaborator: 
has dmc: No
It has been demonstrated that ligaments, both cardinal and uterosacral contain a considerable
      amount of autonomic nerve tissues. The resection of deep infiltrating endometriotic nodules
      at the level of the uterosacral ligaments or the rectovaginal space is supposed to damage the
      supplying autonomic nerve fibers of the lower urinary tract. The bladder receives motor and
      sensitive innervations from both the sympathetic fibers, most of which arise from the
      hypogastric plexuses and nerves, and the parasympathetic fibers, which arise from the pelvic
      splanchnic nerves and the inferior hypogastric plexus; therefore, even bladder function may
      be impaired in women affected by deep endometriosis.

      Very few data have been published regarding the urodynamic functional evaluation of bladder
      in patient with deep endometriosis.So far, it is unknown if the surgery itself causes the
      postoperative bladder dysfunction or if the surgery unmasks a subclinically pre-existing
      detrusor pathology.

      Since the urinary postoperative complications have a strong impact on quality of life of the
      deep endometriosis patients and often requires management (due to a poor spontaneous
      remission), it is crucial a better understanding of the problem. That will help for a more
      appropriate pre-operative counselling.

      Aims of this study are to evaluate the bladder function before and after deep endometriosis
      surgery, using standardized validated instruments and to correlate the localisation of the
      endometriosis lesion, the type/area of surgical dissection with the postoperative bladder
      function.

      This is a prospective multicenter cohort study involving the Department of General
      Gynaecology and Gynecological Oncology of Medical University of Vienna (Austria) and the
      Department of Obstetrics and Gynaecology of Insubria University, Varese (Italy).

      A total of 50 patients are planned to be included. The study protocol consider a Preoperative
      Assessment (clinical examination, transvaginal pelvic ultrasound, preoperative specific
      questionnaire including obstetric, medical, and surgical history and standardized questions
      on pelvic floor dysfunctions, standardized instrumental assessment of the pelvic floor) a
      Intraoperative Assessment (during laparoscopy, the localizations of endometriotic lesions
      recorded and identified by anatomical sites, numbers, and depth of infiltration). Before and
      3 months after surgery a Urodynamic assessment is planned.
observational model: Cohort
time perspective: Prospective
measure: Urodynamic assessment after deep infiltrating endometriosis surgery
time frame: 2 years
description: to evaluate the bladder function before and after deep endometriosis surgery (Unit of Measure: First Desire (ml) from Urodynamic Assessment)
measure: Bladder symptoms after surgery for deep infiltrating endometriosis
time frame: 2 years
description: using standardized validated questionnaires -OABQ short form, ICIQ short form questionnaire, micturition diary.
measure: correlation between localisation of the endometriosis lesion and postoperative bladder function.
time frame: 2 years
description: to correlate the localisation of the endometriosis lesion, the type/area of surgical dissection with a specific urodynamic pattern and/or a specific low urinary tract symptom
arm group label: Deep endometriosis patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Medical University of Vienna
investigator full name: Laterza Rosa Maria
investigator title: Dr. med
mesh term: Endometriosis