<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/NCT03757975</url>
  </required_header>
  <id_info>
    <org_study_id>012018</org_study_id>
    <nct_id>NCT03757975</nct_id>
  </id_info>
  <brief_title>Impact of Hysterectomy on Quality of Life and Urethral Length</brief_title>
  <official_title>Impact of Hysterectomy and Supracervical Hysterectomy on Quality of Life, Urinary Incontinence and Urethral Length</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University of Lublin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University of Lublin</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>
      To establish the impact of hysterectomy on sexual function, urethral length and quality of&#xD;
      life&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators evaluate impact of total hysterectomy (abdominal, by laparoscopy and&#xD;
      vaginal) and supracervical hysterectomy (abdominal and by laparoscopy) on quality of life,&#xD;
      sexual function, urethral length and urinary incontinence. The patients fulfill&#xD;
      questionnaires (UDI 6, IIQ7, FSFI and ICIQ) before operation and 6 months after. Additionally&#xD;
      the investigators measure urethral length before procedure and 6 months after.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 1, 2018</start_date>
  <completion_date type="Anticipated">May 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">April 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline urethral length at 6 months after hysterectomy</measure>
    <time_frame>6 months</time_frame>
    <description>Comparison of urethral length before and after hysterectomy. Urethra will be measured during ultrasound examination in millimeters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in sexual functions at 6 months after hysterectomy</measure>
    <time_frame>6 months</time_frame>
    <description>The patients fulfill FSFI questionnaire before and after hysterectomy. Range 2-36 with higher scores indicating better sexual function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in appearance of urinary incontinence at 6 months after hysterectomy</measure>
    <time_frame>6 months</time_frame>
    <description>The patients fulfill UDI 6 (range 0-400) questionnaire to assess appearance of urinary incontinence before and after hysterectomy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in impact of urinary incontinence at 6 months after hysterectomy</measure>
    <time_frame>6 months</time_frame>
    <description>The patients fulfill IIQ 7 (range 0-400) questionnaire to assess impact of hysterectomy on urinary incontinence.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in urinary tract symptoms at 6 months after hysterectomy</measure>
    <time_frame>6 months</time_frame>
    <description>The patients fulfill ICIQ questionnaire to assess impact of hysterectomy on urinary tract symptoms</description>
  </secondary_outcome>
  <number_of_groups>5</number_of_groups>
  <enrollment type="Anticipated">500</enrollment>
  <condition>Fibroid Uterus</condition>
  <condition>Urethral Diseases</condition>
  <condition>Sex Disorder</condition>
  <arm_group>
    <arm_group_label>TAH</arm_group_label>
    <description>patients before and after total abdominal hysterectomy (TAH)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TLH</arm_group_label>
    <description>patients before and after total laparoscopic hysterectomy (TLH)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>TVH</arm_group_label>
    <description>patients before and after total vaginal hysterectomy (TVH)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SAH</arm_group_label>
    <description>patients before and after abdominal supracervical hysterectomy (SAH)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SLH</arm_group_label>
    <description>patients before and after supracervical laparoscopic hysterectomy (SLH)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>urethral length measure</intervention_name>
    <description>measure of urethral length, distribution of questionnaires before and after operation</description>
    <arm_group_label>SAH</arm_group_label>
    <arm_group_label>SLH</arm_group_label>
    <arm_group_label>TAH</arm_group_label>
    <arm_group_label>TLH</arm_group_label>
    <arm_group_label>TVH</arm_group_label>
    <other_name>UDI 6 and IIQ 7 questionnaires</other_name>
    <other_name>FSFI questionnaire</other_name>
    <other_name>ICIQ questionnaire</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        women who have been qualified to hysterectomy due to fibroids or other benign cndition and&#xD;
        who had not undergone any vaginal operation in the past&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients qualified to hysterectomy due to benign condition&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  serious health condition&#xD;
&#xD;
          -  previous vaginal operations&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tomasz Rechberger, Professor</last_name>
    <role>Study Director</role>
    <affiliation>Medical University of Lublin</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Katarzyna A. Skorupska, PhD</last_name>
    <phone>0048604418512</phone>
    <email>kasiaperzylo@hotmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pawel Miotla, PhD</last_name>
    <phone>0048604793902</phone>
    <email>pmiotla@wp.pl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>2nd Gynecology Department</name>
      <address>
        <city>Lublin</city>
        <zip>20-954</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>katarzyna A. skorupska, PhD</last_name>
      <phone>0048604418512</phone>
      <email>kasiaperzylo@hotmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Pawel Miotla, PhD</last_name>
      <phone>0048604793902</phone>
      <email>pmiotla@wp.pl</email>
    </contact_backup>
    <investigator>
      <last_name>Sara Wawrysiuk, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>November 19, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>February 18, 2020</last_update_submitted>
  <last_update_submitted_qc>February 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University of Lublin</investigator_affiliation>
    <investigator_full_name>Paweł Miotła</investigator_full_name>
    <investigator_title>Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>quality of life</keyword>
  <keyword>urethral length</keyword>
  <keyword>sexual function</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Leiomyoma</mesh_term>
    <mesh_term>Myofibroma</mesh_term>
    <mesh_term>Sexual Dysfunction, Physiological</mesh_term>
    <mesh_term>Urethral Diseases</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/NCT03757975
org study id: 012018
nct id: NCT03757975
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To establish the impact of hysterectomy on sexual function, urethral length and quality of
      life
The investigators evaluate impact of total hysterectomy (abdominal, by laparoscopy and
      vaginal) and supracervical hysterectomy (abdominal and by laparoscopy) on quality of life,
      sexual function, urethral length and urinary incontinence. The patients fulfill
      questionnaires (UDI 6, IIQ7, FSFI and ICIQ) before operation and 6 months after. Additionally
      the investigators measure urethral length before procedure and 6 months after.
observational model: Case-Only
time perspective: Cross-Sectional
measure: Change from Baseline urethral length at 6 months after hysterectomy
time frame: 6 months
description: Comparison of urethral length before and after hysterectomy. Urethra will be measured during ultrasound examination in millimeters
measure: Change from Baseline in sexual functions at 6 months after hysterectomy
time frame: 6 months
description: The patients fulfill FSFI questionnaire before and after hysterectomy. Range 2-36 with higher scores indicating better sexual function.
measure: Change from Baseline in appearance of urinary incontinence at 6 months after hysterectomy
time frame: 6 months
description: The patients fulfill UDI 6 (range 0-400) questionnaire to assess appearance of urinary incontinence before and after hysterectomy
measure: Change from Baseline in impact of urinary incontinence at 6 months after hysterectomy
time frame: 6 months
description: The patients fulfill IIQ 7 (range 0-400) questionnaire to assess impact of hysterectomy on urinary incontinence.
measure: Change from Baseline in urinary tract symptoms at 6 months after hysterectomy
time frame: 6 months
description: The patients fulfill ICIQ questionnaire to assess impact of hysterectomy on urinary tract symptoms
arm group label: TAH
description: patients before and after total abdominal hysterectomy (TAH)
arm group label: TLH
description: patients before and after total laparoscopic hysterectomy (TLH)
arm group label: TVH
description: patients before and after total vaginal hysterectomy (TVH)
arm group label: SAH
description: patients before and after abdominal supracervical hysterectomy (SAH)
arm group label: SLH
description: patients before and after supracervical laparoscopic hysterectomy (SLH)
intervention type: Procedure
intervention name: urethral length measure
description: measure of urethral length, distribution of questionnaires before and after operation
arm group label: SAH
arm group label: SLH
arm group label: TAH
arm group label: TLH
arm group label: TVH
other name: UDI 6 and IIQ 7 questionnaires
other name: FSFI questionnaire
other name: ICIQ questionnaire
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
last name: Tomasz Rechberger, Professor
role: Study Director
affiliation: Medical University of Lublin
last name: Katarzyna A. Skorupska, PhD
phone: 0048604418512
email: kasiaperzylo@hotmail.com
last name: Pawel Miotla, PhD
phone: 0048604793902
email: pmiotla@wp.pl
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Poland
responsible party type: Principal Investigator
investigator affiliation: Medical University of Lublin
investigator full name: Paweł Miotła
investigator title: Clinical Professor
mesh term: Leiomyoma
mesh term: Myofibroma
mesh term: Sexual Dysfunction, Physiological
mesh term: Urethral Diseases
sharing ipd: No