<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/NCT02226237</url>
  </required_header>
  <id_info>
    <org_study_id>FSTXPTR2010</org_study_id>
    <nct_id>NCT02226237</nct_id>
  </id_info>
  <brief_title>Effectiveness of Physiotherapy to Treat the Urinary Incontinence and Erectile Dysfunction Post Retropubic Prostatectomy</brief_title>
  <official_title>URINARY INCONTINENCE AND ERECTIL DYSFUNCTION AFTER RADICAL PROSTATECTOMY: A Randomized Controlled Trial Comparing Pelvic Muscle Exercises With or Without Electrical Stimulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Barretos Cancer Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Barretos Cancer Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The prostate cancer is the most common parenchymal neoplasia in men over 45 years old.&#xD;
      Radical prostatectomy is curative treatment is most used today. Urinary incontinence and&#xD;
      erectile dysfunction are the main complications of radical prostatectomy. Physical therapy&#xD;
      has been used as a form of conservative treatment of these complications. However, the role&#xD;
      of physiotherapy in the treatment of these complications is not well defined in the&#xD;
      literature. We will do a randomized controlled study with patients undergoing radical&#xD;
      prostatectomy. After removal of the Foley catheter, patients will be randomized into 3&#xD;
      groups: control group, group of pelvic floor exercises and anal electrostimulation group.&#xD;
      These patients will be evaluated preoperatively in an attempt to meet prognostic factors for&#xD;
      urinary incontinence and erectile dysfunction. They will be followed by 2 years after&#xD;
      surgery, to assess whether the therapy will alter the course of urinary continence and&#xD;
      erectile function in these patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Randomization was performed by a team of external statistics to the research team, using the&#xD;
      method of randomization in blocks of three, who were randomly selected. The group to which&#xD;
      the patient was allocated to researchers only be informed at the time of randomization, if&#xD;
      patients satisfied the criteria for inclusion and exclusion.&#xD;
&#xD;
      Will be evaluated preoperatively: urodynamic studies and clinical evaluation. The following&#xD;
      clinical data were evaluated: Body Mass Index (BMI), comorbidities, disease staging and&#xD;
      sociodemographic information.&#xD;
&#xD;
      The following parameters will be evaluated in the pre-operative and after one, three, six and&#xD;
      twelve months after surgery: evaluating the strength of the pelvic floor through&#xD;
      perineometry, the 1 hour pad test, electromyographic evaluation of pelvic floor, and the&#xD;
      application of instruments validated for the Portuguese language. The follow instruments will&#xD;
      be applied: International Index of Erectile Function - 5 questions (IIEF-5), International&#xD;
      Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), International Prostate&#xD;
      Symptom Score (IPSS).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2010</start_date>
  <completion_date type="Actual">December 2015</completion_date>
  <primary_completion_date type="Actual">December 2015</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>recovery of urinary continence</measure>
    <time_frame>one year</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>recovery of erectile function</measure>
    <time_frame>two years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>evaluate prognosis for recovery of urinary continence</measure>
    <time_frame>one year</time_frame>
    <description>assess the presence of prognostic factors for the recovery of urinary continence after radical prostatectomy</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">237</enrollment>
  <condition>Urinary Incontinence</condition>
  <condition>Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>in which patients received no specific treatment, only the usual general guidelines</description>
  </arm_group>
  <arm_group>
    <arm_group_label>group of pelvic floor exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>in which patients were instructed to perform home exercises daily</description>
  </arm_group>
  <arm_group>
    <arm_group_label>anal electrostimulation group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>in which patients, and are instructed to perform the exercises mentioned in the group of pelvic floor exercises, also underwent anal electrostimulation</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>group of pelvic floor exercises</intervention_name>
    <description>contraction of the pelvic floor muscles sustained for 5 seconds, hip adductors using pillow and elevation of the hip, 30 repetitions of each exercise</description>
    <arm_group_label>anal electrostimulation group</arm_group_label>
    <arm_group_label>group of pelvic floor exercises</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>anal electrostimulation group</intervention_name>
    <description>The anal electrical stimulation protocol was performed by a physical therapist for seven weeks, twice per week, using the apparatus Dualpex 961 Uro® Quark, with frequency of 35 Hz, and the intensity determined according to the tolerance of the patient, lasting 20 minutes.</description>
    <arm_group_label>anal electrostimulation group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients over 18 years&#xD;
&#xD;
          -  diagnosed with localized or locally advanced prostate cancer&#xD;
&#xD;
          -  that are undergoing radical prostatectomy as treatment of the condition&#xD;
&#xD;
          -  they are coming from Barretos or a nearby region or has logistics facilities to come&#xD;
             to the Barretos Cancer Hospital to perform the followup&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  those with mental or physical problems that make it impossible to collect data or that&#xD;
             may influence the recovery of continence postoperatively&#xD;
&#xD;
          -  patients with metastatic prostate cancer&#xD;
&#xD;
          -  patients not undergoing retropubic prostatectomy as treatment for prostate cancer&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wesley J Magnabosco, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Barretos Cancer Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>João L Amaro, PhDh</last_name>
    <role>Study Director</role>
    <affiliation>UPECLIN HC FM Botucatu Unesp</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carla LC Andrade</last_name>
    <role>Principal Investigator</role>
    <affiliation>Barretos Cancer Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fernanda Jabur</last_name>
    <role>Principal Investigator</role>
    <affiliation>Barretos Cancer Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Barretos Cancer Hospital</name>
      <address>
        <city>Barretos</city>
        <state>São Paulo State</state>
        <zip>14780000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2016</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 27, 2014</study_first_posted>
  <last_update_submitted>January 13, 2016</last_update_submitted>
  <last_update_submitted_qc>January 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 14, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Barretos Cancer Hospital</investigator_affiliation>
    <investigator_full_name>Wesley Justino Magnabosco</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>urinary incontinence</keyword>
  <keyword>erectile dysfunction</keyword>
  <keyword>Retropubic Prostatectomy</keyword>
  <keyword>Physiotherapy</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>
    <mesh_term>Erectile Dysfunction</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/NCT02226237
org study id: FSTXPTR2010
nct id: NCT02226237
lead sponsor: 
collaborator: 
has dmc: No
The prostate cancer is the most common parenchymal neoplasia in men over 45 years old.
      Radical prostatectomy is curative treatment is most used today. Urinary incontinence and
      erectile dysfunction are the main complications of radical prostatectomy. Physical therapy
      has been used as a form of conservative treatment of these complications. However, the role
      of physiotherapy in the treatment of these complications is not well defined in the
      literature. We will do a randomized controlled study with patients undergoing radical
      prostatectomy. After removal of the Foley catheter, patients will be randomized into 3
      groups: control group, group of pelvic floor exercises and anal electrostimulation group.
      These patients will be evaluated preoperatively in an attempt to meet prognostic factors for
      urinary incontinence and erectile dysfunction. They will be followed by 2 years after
      surgery, to assess whether the therapy will alter the course of urinary continence and
      erectile function in these patients.
Randomization was performed by a team of external statistics to the research team, using the
      method of randomization in blocks of three, who were randomly selected. The group to which
      the patient was allocated to researchers only be informed at the time of randomization, if
      patients satisfied the criteria for inclusion and exclusion.

      Will be evaluated preoperatively: urodynamic studies and clinical evaluation. The following
      clinical data were evaluated: Body Mass Index (BMI), comorbidities, disease staging and
      sociodemographic information.

      The following parameters will be evaluated in the pre-operative and after one, three, six and
      twelve months after surgery: evaluating the strength of the pelvic floor through
      perineometry, the 1 hour pad test, electromyographic evaluation of pelvic floor, and the
      application of instruments validated for the Portuguese language. The follow instruments will
      be applied: International Index of Erectile Function - 5 questions (IIEF-5), International
      Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF), International Prostate
      Symptom Score (IPSS).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: recovery of urinary continence
time frame: one year
measure: recovery of erectile function
time frame: two years
measure: evaluate prognosis for recovery of urinary continence
time frame: one year
description: assess the presence of prognostic factors for the recovery of urinary continence after radical prostatectomy
arm group label: Control Group
arm group type: No Intervention
description: in which patients received no specific treatment, only the usual general guidelines
arm group label: group of pelvic floor exercises
arm group type: Experimental
description: in which patients were instructed to perform home exercises daily
arm group label: anal electrostimulation group
arm group type: Experimental
description: in which patients, and are instructed to perform the exercises mentioned in the group of pelvic floor exercises, also underwent anal electrostimulation
intervention type: Procedure
intervention name: group of pelvic floor exercises
description: contraction of the pelvic floor muscles sustained for 5 seconds, hip adductors using pillow and elevation of the hip, 30 repetitions of each exercise
arm group label: anal electrostimulation group
arm group label: group of pelvic floor exercises
intervention type: Procedure
intervention name: anal electrostimulation group
description: The anal electrical stimulation protocol was performed by a physical therapist for seven weeks, twice per week, using the apparatus Dualpex 961 Uro® Quark, with frequency of 35 Hz, and the intensity determined according to the tolerance of the patient, lasting 20 minutes.
arm group label: anal electrostimulation group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Wesley J Magnabosco, MD
role: Principal Investigator
affiliation: Barretos Cancer Hospital
last name: João L Amaro, PhDh
role: Study Director
affiliation: UPECLIN HC FM Botucatu Unesp
last name: Carla LC Andrade
role: Principal Investigator
affiliation: Barretos Cancer Hospital
last name: Fernanda Jabur
role: Principal Investigator
affiliation: Barretos Cancer Hospital
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: Barretos Cancer Hospital
investigator full name: Wesley Justino Magnabosco
investigator title: MD
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Erectile Dysfunction