<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/NCT03302169</url>
  </required_header>
  <id_info>
    <org_study_id>PR(AG)330/2016</org_study_id>
    <nct_id>NCT03302169</nct_id>
  </id_info>
  <brief_title>Trial to Compare Urinary Continence Recovery After Robotic Radical Prostatectomy With or Without Rhabdosphincter Reconstruction.</brief_title>
  <acronym>RHABDO-PROST</acronym>
  <official_title>Prospective Randomized Controlled Trial to Compare Early Urinary Continence Recovery After Robotic Assisted Radical Prostatectomy With or Without Posterior Rhabdosphincter Reconstruction.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital Universitari Vall d'Hebron Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital Universitari Vall d'Hebron Research Institute</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>
      This is a prospective randomized controlled trail to assess early urinary continence recovery&#xD;
      rates after robotic assisted radical prostatectomy when a posterior rhabdosphincter&#xD;
      reconstruction is performed or not. A hundred forty-six patients with clinically localized&#xD;
      and histological confirmed prostate cancer will be enrolled. Continence recovery is defined&#xD;
      in the present study as declared urinary continence (absence of incontinence episodes) in the&#xD;
      physician interview as no pad use. Continence rates will be explored also by EPIC, ICIQ-SF,&#xD;
      IPSS questionnaires 1, 6 and 12 months after the procedure. The sexual function as the&#xD;
      secondary objective will be assessed by SHIM questionnaire.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">November 1, 2019</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>Single Group Assignment</intervention_model>
    <intervention_model_description>This is a prospective randomized controlled trial to assess early urinary continence recovery rates after robotic assisted radical prostatectomy when a posterior rhabdosphincter reconstruction is performed or not.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 1st monthNumber of patients using 0-1 PAD/d (EPIC-26 question_5) at 1st month</measure>
    <time_frame>1 month after surgery</time_frame>
    <description>Absence of urinary incontinence (number of PADs/d)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 6th month</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>Absence of urinary incontinence (number of PADs/d)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>early urinary recovery quantification in Grams (PAD-test 24h)</measure>
    <time_frame>one day before catheter removal, 2 weeks before and 1 month before</time_frame>
    <description>PAD-test during the first month after surgery</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 12th month</measure>
    <time_frame>12 months after surgery</time_frame>
    <description>Absence of urinary incontinence (number of PADs/d)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Erectile function</measure>
    <time_frame>1, 6 and 12 months</time_frame>
    <description>SHIM assessment</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life I: urinary and bowel function</measure>
    <time_frame>1, 6 and 12 months</time_frame>
    <description>EPIC-26 urinary and digestive function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life II: urinary function</measure>
    <time_frame>1, 6 and 12 months</time_frame>
    <description>ICIQ-SF assessment of urinary function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life III: urinary function</measure>
    <time_frame>1, 6 and 12 months</time_frame>
    <description>IPSS assessment of urinary function</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oncological outcome: Biochemical free-recurrence status</measure>
    <time_frame>1, 6 and 12 months</time_frame>
    <description>serum PSA assessment. Biochemical free-recurrence status = PSA &lt;0.2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anatomopathological parameters: Surgical margins</measure>
    <time_frame>1 month</time_frame>
    <description>Surgery margins in prostatectomy specimens</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anatomopathological parameters: pTNM classification</measure>
    <time_frame>1 month</time_frame>
    <description>Pathological pTNM in prostatectomy specimens</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">156</enrollment>
  <condition>Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Posterior Rhabdosphincter Reconstruction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in who posterior rhabdosphincter reconstruction is performed</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients in who posterior rhabdosphincter reconstruction is NOT performed, Standard technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radical prostatectomy with posterior rhabdosphincter reconstruction</intervention_name>
    <description>To suture the Denonvilliers fascia and bladder to the median dorsal raphe according to Rocco technique.</description>
    <arm_group_label>Posterior Rhabdosphincter Reconstruction</arm_group_label>
    <other_name>Rocco reconstruction technique</other_name>
    <other_name>Posterior reconstruction</other_name>
    <other_name>Rocco Stitch</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Radical prostatectomy without posterior rhabdosphincter reconstruction</intervention_name>
    <description>Standard technique with a running suture to perform the urethrovesical anastomosis</description>
    <arm_group_label>Standard Technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Histological confirmation of prostate cancer&#xD;
&#xD;
          -  Localized or locally advanced prostate cancer&#xD;
&#xD;
          -  Informed consent signed&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Presence of urinary incontinence prior to the procedure&#xD;
&#xD;
          -  Previous radiation therapy of the prostate or pelvis&#xD;
&#xD;
          -  Presence of any prostatic surgery prior to the procedure&#xD;
&#xD;
          -  Prior medical history of psychiatric diseases or drug addiction&#xD;
&#xD;
          -  Any condition that contraindicates a radical prostatectomy&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Juan Morote, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Vall d'Hebron</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital Universitari Vall d'Hebron</name>
      <address>
        <city>Barcelona</city>
        <zip>08035</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 15, 2017</study_first_submitted>
  <study_first_submitted_qc>September 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 5, 2017</study_first_posted>
  <last_update_submitted>October 7, 2020</last_update_submitted>
  <last_update_submitted_qc>October 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 9, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate Cancer</keyword>
  <keyword>Urinary incontinence</keyword>
  <keyword>Radical prostatectomy</keyword>
  <keyword>Rhabdosphincter</keyword>
  <keyword>Robotic Surgery</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>
  <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/NCT03302169
org study id: PR(AG)330/2016
nct id: NCT03302169
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This is a prospective randomized controlled trail to assess early urinary continence recovery
      rates after robotic assisted radical prostatectomy when a posterior rhabdosphincter
      reconstruction is performed or not. A hundred forty-six patients with clinically localized
      and histological confirmed prostate cancer will be enrolled. Continence recovery is defined
      in the present study as declared urinary continence (absence of incontinence episodes) in the
      physician interview as no pad use. Continence rates will be explored also by EPIC, ICIQ-SF,
      IPSS questionnaires 1, 6 and 12 months after the procedure. The sexual function as the
      secondary objective will be assessed by SHIM questionnaire.
allocation: Randomized
intervention model: Single Group Assignment
intervention model description: This is a prospective randomized controlled trial to assess early urinary continence recovery rates after robotic assisted radical prostatectomy when a posterior rhabdosphincter reconstruction is performed or not.
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 1st monthNumber of patients using 0-1 PAD/d (EPIC-26 question_5) at 1st month
time frame: 1 month after surgery
description: Absence of urinary incontinence (number of PADs/d)
measure: Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 6th month
time frame: 6 months after surgery
description: Absence of urinary incontinence (number of PADs/d)
measure: early urinary recovery quantification in Grams (PAD-test 24h)
time frame: one day before catheter removal, 2 weeks before and 1 month before
description: PAD-test during the first month after surgery
measure: Number of patients using 0-1 PAD/d (EPIC-26 question_5) at 12th month
time frame: 12 months after surgery
description: Absence of urinary incontinence (number of PADs/d)
measure: Erectile function
time frame: 1, 6 and 12 months
description: SHIM assessment
measure: Quality of life I: urinary and bowel function
time frame: 1, 6 and 12 months
description: EPIC-26 urinary and digestive function
measure: Quality of life II: urinary function
time frame: 1, 6 and 12 months
description: ICIQ-SF assessment of urinary function
measure: Quality of life III: urinary function
time frame: 1, 6 and 12 months
description: IPSS assessment of urinary function
measure: Oncological outcome: Biochemical free-recurrence status
time frame: 1, 6 and 12 months
description: serum PSA assessment. Biochemical free-recurrence status = PSA <0.2
measure: Anatomopathological parameters: Surgical margins
time frame: 1 month
description: Surgery margins in prostatectomy specimens
measure: Anatomopathological parameters: pTNM classification
time frame: 1 month
description: Pathological pTNM in prostatectomy specimens
arm group label: Posterior Rhabdosphincter Reconstruction
arm group type: Experimental
description: Patients in who posterior rhabdosphincter reconstruction is performed
arm group label: Standard Technique
arm group type: Active Comparator
description: Patients in who posterior rhabdosphincter reconstruction is NOT performed, Standard technique.
intervention type: Procedure
intervention name: Radical prostatectomy with posterior rhabdosphincter reconstruction
description: To suture the Denonvilliers fascia and bladder to the median dorsal raphe according to Rocco technique.
arm group label: Posterior Rhabdosphincter Reconstruction
other name: Rocco reconstruction technique
other name: Posterior reconstruction
other name: Rocco Stitch
intervention type: Procedure
intervention name: Radical prostatectomy without posterior rhabdosphincter reconstruction
description: Standard technique with a running suture to perform the urethrovesical anastomosis
arm group label: Standard Technique
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Juan Morote, PhD
role: Principal Investigator
affiliation: Hospital Vall d'Hebron
facility: 
country: Spain
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
sharing ipd: No