<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/NCT03020238</url>
  </required_header>
  <id_info>
    <org_study_id>PUMCH-OBGYN-2013</org_study_id>
    <nct_id>NCT03020238</nct_id>
  </id_info>
  <brief_title>Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics</brief_title>
  <official_title>Impact of Nerve-sparing Radical Hysterectomy on Patients' Urinary Dynamics: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking Union Medical College Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background: Radical hysterectomy is an important therapy for early cervical cancer.&#xD;
      Disfunction of urinary dynamics is the most common postoperative adverse effects, which had&#xD;
      negative impact on patients' quality of life. Nerve sparing radical hysterectomy (NSRH) could&#xD;
      reserve inferior hypogastric plexus (IHP) innervating bladder, hence improving postoperative&#xD;
      urinary dynamics. Furthermore impact of different energy instruments on urinary dynamic isn't&#xD;
      clear.&#xD;
&#xD;
      Objectives: This study is to compare urinary dynamics before and after NSRH, and to analyze&#xD;
      the difference between BiClamp forcep (BiClamp® forcep, ERBE Elektromedizin, GmbH, Tuebingen,&#xD;
      Germany) and water jet (ERBEJET®2) about the effects of dissecting IHP.&#xD;
&#xD;
      Study population: Cervical cancer of FIGO IB stage, among which 120 cases are enrolled to&#xD;
      randomly allocated to BiClamp group or water jet group.&#xD;
&#xD;
      Intervention: Patients accept NSRH which all will be accomplished by Professor Ming Wu.&#xD;
&#xD;
      Methods: All surgical patients are accessed via urinary dynamics before and four months after&#xD;
      NSRH. On the 14th day after surgeries, urinary catheter will be removed and residual urine&#xD;
      volume (RUV) will be measured. For patients of RUV &gt; 100 ml, urinary catheter will be&#xD;
      replaced.&#xD;
&#xD;
      Primary study endpoint: the successful rate of removing urinary catheter on the 14th day&#xD;
      after NSRH.&#xD;
&#xD;
      Secondary study endpoint: urinary dynamics four months after NSRH.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2013</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>successful rate of removing urinary catheter</measure>
    <time_frame>14th day after nerve-sparing radical hysterectomy</time_frame>
    <description>successful rate (%) of removing urinary catheter assessed by residual urine volume less than 100 ml</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>urinary dynamics parameters determined by urodynamics apparatus: bladder capacity and sensation</measure>
    <time_frame>four months after nerve-sparing radical hysterectomy</time_frame>
    <description>bladder capacity and sensation in ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>urinary dynamics parameters determined by urodynamics apparatus: residual urine volume</measure>
    <time_frame>four months after nerve-sparing radical hysterectomy</time_frame>
    <description>residual urine volume in ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>urinary dynamics parameters determined by urodynamics apparatus: urine flow rate</measure>
    <time_frame>four months after nerve-sparing radical hysterectomy</time_frame>
    <description>urine flow rate in ml/s</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>urinary dynamics parameters determined by urodynamics apparatus: bladder pressure</measure>
    <time_frame>four months after nerve-sparing radical hysterectomy</time_frame>
    <description>bladder pressure in cmH2O</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>urinary dynamics parameters determined by urodynamics apparatus: detrusor pressure</measure>
    <time_frame>four months after nerve-sparing radical hysterectomy</time_frame>
    <description>detrusor pressure in cmH2O</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>urinary dynamics parameters determined by urodynamics apparatus: bladder compliance</measure>
    <time_frame>four months after nerve-sparing radical hysterectomy</time_frame>
    <description>bladder compliance in ml/cmH2O</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>survival outcomes: ovarall survival</measure>
    <time_frame>two years after nerve-sparing radical hysterectomy</time_frame>
    <description>overall survival in months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>survival outcomes: progression-free survival</measure>
    <time_frame>two years after nerve-sparing radical hysterectomy</time_frame>
    <description>progression-free survival in months</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">120</enrollment>
  <condition>Cervical Cancer</condition>
  <condition>Urinary Retention</condition>
  <arm_group>
    <arm_group_label>BiClamp group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>BiClamp forcep (BiClamp® forcep, ERBE Elektromedizin, GmbH, Tuebingen, Germany) is used to dissect inferior hypogastric plexus</description>
  </arm_group>
  <arm_group>
    <arm_group_label>water jet group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>water jet (ERBEJET®2, ERBE Elektromedizin, GmbH, Tuebingen, Germany) is used to dissect inferior hypogastric plexus</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>BiClamp group</intervention_name>
    <description>electric energy</description>
    <arm_group_label>BiClamp group</arm_group_label>
    <other_name>BiClamp® forcep, ERBE Elektromedizin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>water jet group</intervention_name>
    <description>water jet energy</description>
    <arm_group_label>water jet group</arm_group_label>
    <other_name>ERBEJET®2, ERBE Elektromedizin</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  FIGO stage IB&#xD;
&#xD;
          -  ASA score 0-2&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Radiotherapy or chemotherapy before surgeries&#xD;
&#xD;
          -  ASA score &gt; 2&#xD;
&#xD;
          -  With abnormal urinary dynamics before surgeries&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wu Ming, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 11, 2017</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>January 12, 2017</last_update_submitted>
  <last_update_submitted_qc>January 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 13, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Lei Li</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Retention</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>IPD will be shared with authorised researchers via online database.</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/NCT03020238
org study id: PUMCH-OBGYN-2013
nct id: NCT03020238
lead sponsor: 
has dmc: Yes
Background: Radical hysterectomy is an important therapy for early cervical cancer.
      Disfunction of urinary dynamics is the most common postoperative adverse effects, which had
      negative impact on patients' quality of life. Nerve sparing radical hysterectomy (NSRH) could
      reserve inferior hypogastric plexus (IHP) innervating bladder, hence improving postoperative
      urinary dynamics. Furthermore impact of different energy instruments on urinary dynamic isn't
      clear.

      Objectives: This study is to compare urinary dynamics before and after NSRH, and to analyze
      the difference between BiClamp forcep (BiClamp® forcep, ERBE Elektromedizin, GmbH, Tuebingen,
      Germany) and water jet (ERBEJET®2) about the effects of dissecting IHP.

      Study population: Cervical cancer of FIGO IB stage, among which 120 cases are enrolled to
      randomly allocated to BiClamp group or water jet group.

      Intervention: Patients accept NSRH which all will be accomplished by Professor Ming Wu.

      Methods: All surgical patients are accessed via urinary dynamics before and four months after
      NSRH. On the 14th day after surgeries, urinary catheter will be removed and residual urine
      volume (RUV) will be measured. For patients of RUV > 100 ml, urinary catheter will be
      replaced.

      Primary study endpoint: the successful rate of removing urinary catheter on the 14th day
      after NSRH.

      Secondary study endpoint: urinary dynamics four months after NSRH.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: successful rate of removing urinary catheter
time frame: 14th day after nerve-sparing radical hysterectomy
description: successful rate (%) of removing urinary catheter assessed by residual urine volume less than 100 ml
measure: urinary dynamics parameters determined by urodynamics apparatus: bladder capacity and sensation
time frame: four months after nerve-sparing radical hysterectomy
description: bladder capacity and sensation in ml
measure: urinary dynamics parameters determined by urodynamics apparatus: residual urine volume
time frame: four months after nerve-sparing radical hysterectomy
description: residual urine volume in ml
measure: urinary dynamics parameters determined by urodynamics apparatus: urine flow rate
time frame: four months after nerve-sparing radical hysterectomy
description: urine flow rate in ml/s
measure: urinary dynamics parameters determined by urodynamics apparatus: bladder pressure
time frame: four months after nerve-sparing radical hysterectomy
description: bladder pressure in cmH2O
measure: urinary dynamics parameters determined by urodynamics apparatus: detrusor pressure
time frame: four months after nerve-sparing radical hysterectomy
description: detrusor pressure in cmH2O
measure: urinary dynamics parameters determined by urodynamics apparatus: bladder compliance
time frame: four months after nerve-sparing radical hysterectomy
description: bladder compliance in ml/cmH2O
measure: survival outcomes: ovarall survival
time frame: two years after nerve-sparing radical hysterectomy
description: overall survival in months
measure: survival outcomes: progression-free survival
time frame: two years after nerve-sparing radical hysterectomy
description: progression-free survival in months
arm group label: BiClamp group
arm group type: Placebo Comparator
description: BiClamp forcep (BiClamp® forcep, ERBE Elektromedizin, GmbH, Tuebingen, Germany) is used to dissect inferior hypogastric plexus
arm group label: water jet group
arm group type: Active Comparator
description: water jet (ERBEJET®2, ERBE Elektromedizin, GmbH, Tuebingen, Germany) is used to dissect inferior hypogastric plexus
intervention type: Procedure
intervention name: BiClamp group
description: electric energy
arm group label: BiClamp group
other name: BiClamp® forcep, ERBE Elektromedizin
intervention type: Procedure
intervention name: water jet group
description: water jet energy
arm group label: water jet group
other name: ERBEJET®2, ERBE Elektromedizin
criteria: 
gender: Female
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Wu Ming, MD
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Lei Li
investigator title: Associate Professor
mesh term: Urinary Retention
sharing ipd: Yes
ipd description: IPD will be shared with authorised researchers via online database.