<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/NCT01714219</url>
  </required_header>
  <id_info>
    <org_study_id>SNUBH-URO-2012-02</org_study_id>
    <nct_id>NCT01714219</nct_id>
  </id_info>
  <brief_title>Effect of New Posterior Reconstruction Method on Recovery of Continence After Robot-assisted Laparoscopic Prostatectomy</brief_title>
  <official_title>Effect of New Posterior Reconstruction Method on Recovery of Continence After Robot-assisted Laparoscopic Prostatectomy: Prospective, Single-blinded, Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Seoul National University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Seoul National University Bundang Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Seoul National University Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Incontinence is one of the most common complications of radical prostatectomy. The continence&#xD;
      rate is not significantly improved even by robot-assisted laparoscopic prostatectomy (RALP).&#xD;
      However, some reports suggested that posterior reconstruction (PR) behind vesicourethral&#xD;
      anastomosis could improve early recovery of continence during open, laparoscopic or&#xD;
      robot-assisted radical prostatectomy.&#xD;
&#xD;
      But, recent prospective studies reported no benefit of PR after RALP, which was the opposite&#xD;
      result of those of previous studies. However the PR techniques used in these prospective&#xD;
      studies seem to be quite different from the previous techniques. They seem to have used&#xD;
      single-step PR, which opposes the median dorsal fibrous raphe (MDFR) only to the&#xD;
      Denonvilliers' fascia (DF). By contrast, the original technique incorporated additional&#xD;
      reconstruction between the MDFR and the posterior bladder wall 1-2 cm from the new bladder&#xD;
      neck.&#xD;
&#xD;
      Our group identified this anatomic structure as the posterior counterpart of the detrusor&#xD;
      apron (PDA). The PDA is a strong, thick functional tissue containing muscle that is more&#xD;
      appropriate for pulling and fixing the MDFR than the DF. As such, we hypothesized that the&#xD;
      key proximal structure for PR is not DF, but rather PDA. Furthermore, single-step&#xD;
      reconstruction between MDFR and PDA could be enough for PR. We previously investigated&#xD;
      whether our new PR technique, which entails opposition of the MDFR solely to the PDA, would&#xD;
      improve continence recovery compared with the standard RALP technique without PR. And our&#xD;
      retrospective study demonstrated that this new PR technique during RALP significantly&#xD;
      shortens the time to the recovery of continence compared with the standard technique, which&#xD;
      does not incorporate PR (Int J Urol, 2012;19:683-7).&#xD;
&#xD;
      Thus, we plan to validate this result by a well-designed, prospective, randomized controlled&#xD;
      study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">March 2014</completion_date>
  <primary_completion_date type="Actual">March 2014</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Complete recovery of urinary continence</measure>
    <time_frame>6 months</time_frame>
    <description>Duration of complete continence recovery defined as no pad use measured by question 5 of EPIC questionnaire.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Duration of social continence recovery</measure>
    <time_frame>6 months</time_frame>
    <description>Defined as 0 or 1 measured by EPIC question 5.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Continence score at 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>By EPIC question 5.&#xD;
0 vs. 1-3&#xD;
mean value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary leak at 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>By EPIC question 1,&#xD;
1-3 vs. 4-5&#xD;
mean value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self perception (QoL) of urinary function at 3 months</measure>
    <time_frame>3 months</time_frame>
    <description>By EPIC question 7,&#xD;
0-1 vs. 2-4&#xD;
mean value</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total operative time</measure>
    <time_frame>At the day of surgery</time_frame>
    <description>Total operative time&#xD;
Console time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Estimated blood loss</measure>
    <time_frame>At the day of surgery</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication</measure>
    <time_frame>6 months</time_frame>
    <description>Complication by modified Clavien-Dindo grade</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Localized Prostate Cancer</condition>
  <condition>Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Posterior reconstruction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>New posterior reconstruction, which entails opposition of the median dorsal fibrous raphe solely to the posterior counterpart of the detrusor apron&#xD;
Vesicourethral anastomosis using the van Velthoven method&#xD;
Anterior reconstruction, which involved opposing the anterior detrusor apron to the remaining puboprostatic ligaments and dorsal vascular complex</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No posterior reconstruction</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>No posterior reconstruction&#xD;
Vesicourethral anastomosis using the van Velthoven method&#xD;
Anterior reconstruction, which involved opposing the anterior detrusor apron to the remaining puboprostatic ligaments and dorsal vascular complex</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Posterior reconstruction</intervention_name>
    <arm_group_label>Posterior reconstruction</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  pathologically proven localized prostate cancer (≤cT3a)&#xD;
&#xD;
          -  patients to undergo robot-assisted laparoscopic prostatectomy by a single surgeon&#xD;
             (Sang Eun Lee)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prior hormone therapy&#xD;
&#xD;
          -  prior radiation treatment on prostate or pelvis&#xD;
&#xD;
          -  preoperative urinary incontinence&#xD;
&#xD;
          -  refused to participate&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sang Eun Lee, M.D., Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seoul National University Bundang Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Seoul National University Bundang Hospital</name>
      <address>
        <city>Seongnam</city>
        <state>Gyeonggi-do</state>
        <zip>Gyeonggi-do</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>October 19, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 25, 2012</study_first_posted>
  <last_update_submitted>September 25, 2014</last_update_submitted>
  <last_update_submitted_qc>September 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 29, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Seoul National University Bundang Hospital</investigator_affiliation>
    <investigator_full_name>Sang Eun Lee</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>prostatic neoplasms</keyword>
  <keyword>prostatectomy</keyword>
  <keyword>robotics</keyword>
  <keyword>urinary incontinence</keyword>
  <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>
  <!-- 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/NCT01714219
org study id: SNUBH-URO-2012-02
nct id: NCT01714219
lead sponsor: 
collaborator: 
has dmc: Yes
Incontinence is one of the most common complications of radical prostatectomy. The continence
      rate is not significantly improved even by robot-assisted laparoscopic prostatectomy (RALP).
      However, some reports suggested that posterior reconstruction (PR) behind vesicourethral
      anastomosis could improve early recovery of continence during open, laparoscopic or
      robot-assisted radical prostatectomy.

      But, recent prospective studies reported no benefit of PR after RALP, which was the opposite
      result of those of previous studies. However the PR techniques used in these prospective
      studies seem to be quite different from the previous techniques. They seem to have used
      single-step PR, which opposes the median dorsal fibrous raphe (MDFR) only to the
      Denonvilliers' fascia (DF). By contrast, the original technique incorporated additional
      reconstruction between the MDFR and the posterior bladder wall 1-2 cm from the new bladder
      neck.

      Our group identified this anatomic structure as the posterior counterpart of the detrusor
      apron (PDA). The PDA is a strong, thick functional tissue containing muscle that is more
      appropriate for pulling and fixing the MDFR than the DF. As such, we hypothesized that the
      key proximal structure for PR is not DF, but rather PDA. Furthermore, single-step
      reconstruction between MDFR and PDA could be enough for PR. We previously investigated
      whether our new PR technique, which entails opposition of the MDFR solely to the PDA, would
      improve continence recovery compared with the standard RALP technique without PR. And our
      retrospective study demonstrated that this new PR technique during RALP significantly
      shortens the time to the recovery of continence compared with the standard technique, which
      does not incorporate PR (Int J Urol, 2012;19:683-7).

      Thus, we plan to validate this result by a well-designed, prospective, randomized controlled
      study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Complete recovery of urinary continence
time frame: 6 months
description: Duration of complete continence recovery defined as no pad use measured by question 5 of EPIC questionnaire.
measure: Duration of social continence recovery
time frame: 6 months
description: Defined as 0 or 1 measured by EPIC question 5.
measure: Continence score at 3 months
time frame: 3 months
description: By EPIC question 5.
0 vs. 1-3
mean value
measure: Urinary leak at 3 months
time frame: 3 months
description: By EPIC question 1,
1-3 vs. 4-5
mean value
measure: Self perception (QoL) of urinary function at 3 months
time frame: 3 months
description: By EPIC question 7,
0-1 vs. 2-4
mean value
measure: Total operative time
time frame: At the day of surgery
description: Total operative time
Console time
measure: Estimated blood loss
time frame: At the day of surgery
measure: Complication
time frame: 6 months
description: Complication by modified Clavien-Dindo grade
arm group label: Posterior reconstruction
arm group type: Experimental
description: New posterior reconstruction, which entails opposition of the median dorsal fibrous raphe solely to the posterior counterpart of the detrusor apron
Vesicourethral anastomosis using the van Velthoven method
Anterior reconstruction, which involved opposing the anterior detrusor apron to the remaining puboprostatic ligaments and dorsal vascular complex
arm group label: No posterior reconstruction
arm group type: No Intervention
description: No posterior reconstruction
Vesicourethral anastomosis using the van Velthoven method
Anterior reconstruction, which involved opposing the anterior detrusor apron to the remaining puboprostatic ligaments and dorsal vascular complex
intervention type: Procedure
intervention name: Posterior reconstruction
arm group label: Posterior reconstruction
criteria: 
gender: Male
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Sang Eun Lee, M.D., Ph.D.
role: Principal Investigator
affiliation: Seoul National University Bundang Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Seoul National University Bundang Hospital
investigator full name: Sang Eun Lee
investigator title: Professor
mesh term: Urinary Incontinence
mesh term: Enuresis