<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/NCT02998216</url>
  </required_header>
  <id_info>
    <org_study_id>442/2016BO2</org_study_id>
    <nct_id>NCT02998216</nct_id>
  </id_info>
  <brief_title>Pelvic Floor Symptoms After Bilateral Sacrospinous Fixation</brief_title>
  <official_title>Pelvic Floor Symptoms and Patients´ Satisfaction After Bilateral Sacrospinous Fixation for the Primary Treatment of Pelvic Organ Prolapse ICS-POPQ Stage IV: A Prospective Observational Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Tuebingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Tuebingen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to the assessment of pelvic floor symptoms and patients´ satisfaction after&#xD;
      bilateral sacrospinous fixation for the primary treatment of pelvic organ prolapse stage IV.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2016</start_date>
  <completion_date type="Anticipated">May 2017</completion_date>
  <primary_completion_date type="Anticipated">May 2017</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>Assessment of pelvic floor symptoms</measure>
    <time_frame>Twelve months</time_frame>
    <description>Using the validated Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Anatomical outcome / Prolapse stage after surgery</measure>
    <time_frame>Twelve months</time_frame>
    <description>Using the POP-Q classification tool of the International Continence Society (Bump RC et al, Am J Obstet Gynecol 1996)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in quality of life</measure>
    <time_frame>Twelve months</time_frame>
    <description>Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in sexual activity</measure>
    <time_frame>Twelve months</time_frame>
    <description>Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)</description>
  </secondary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Pelvic Organ Prolapse</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bilateral sacrospinous fixation</intervention_name>
    <description>Bilateral sacrospinous vaginal suspension</description>
    <other_name>Bilateral sacrospinous vaginal suspension</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All female patients who are planned to receive a bilateral sacrospinous fixation as a&#xD;
        treatment for pelvic organ prolapse Stage IV will be eligible for inclusion in the study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age 18 and above&#xD;
&#xD;
          -  pelvic organ prolapse ICS-POPQ Stage IV, with or without uterus&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  gynecologic surgery in the three past months before planned surgery&#xD;
&#xD;
          -  history of prolapse surgery&#xD;
&#xD;
          -  participation in another study&#xD;
&#xD;
          -  need to simultaneously perform other surgical procedures (i.e. rectopexy)&#xD;
&#xD;
          -  ongoing chemotherapy of treatment with immunosuppressant drugs&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christl Reisenauer, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitys Hospital Tuebingen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tilemachos Kavvadias, MD</last_name>
    <phone>+49 7071 2982211</phone>
    <email>tilemachos.kavvadias@med.uni-tuebingen.de</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital Tuebingen</name>
      <address>
        <city>Tubingen</city>
        <state>Baden-Wuerttemberg</state>
        <zip>72072</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 11, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>December 15, 2016</last_update_submitted>
  <last_update_submitted_qc>December 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 20, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT02998216
org study id: 442/2016BO2
nct id: NCT02998216
lead sponsor: 
has dmc: No
This study aims to the assessment of pelvic floor symptoms and patients´ satisfaction after
      bilateral sacrospinous fixation for the primary treatment of pelvic organ prolapse stage IV.
observational model: Cohort
time perspective: Prospective
measure: Assessment of pelvic floor symptoms
time frame: Twelve months
description: Using the validated Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)
measure: Anatomical outcome / Prolapse stage after surgery
time frame: Twelve months
description: Using the POP-Q classification tool of the International Continence Society (Bump RC et al, Am J Obstet Gynecol 1996)
measure: Changes in quality of life
time frame: Twelve months
description: Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)
measure: Changes in sexual activity
time frame: Twelve months
description: Germen Pelvic Floor Questionnaire (Baessler et al, Neurourol Urodynam 2004)
intervention type: Procedure
intervention name: Bilateral sacrospinous fixation
description: Bilateral sacrospinous vaginal suspension
other name: Bilateral sacrospinous vaginal suspension
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christl Reisenauer, Professor
role: Principal Investigator
affiliation: Universitys Hospital Tuebingen
last name: Tilemachos Kavvadias, MD
phone: +49 7071 2982211
email: tilemachos.kavvadias@med.uni-tuebingen.de
facility: 
status: Recruiting
country: Germany
responsible party type: Sponsor
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
sharing ipd: No