<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/NCT03027986</url>
  </required_header>
  <id_info>
    <org_study_id>2015/210/HP</org_study_id>
    <nct_id>NCT03027986</nct_id>
  </id_info>
  <brief_title>Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy</brief_title>
  <acronym>PROTOMEN</acronym>
  <official_title>Evaluation of a Postural Rehabilitation Program Based on Sensory-motor Control in Men With Urinary Incontinence After Prostatectomy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</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>
      Urinary incontinence (UI) is defined by the International Continence Society as &quot;any&#xD;
      involuntary loss of urine complained by the patient&quot;. The anatomical and histological&#xD;
      specificities of the pelvic floor muscles (PFM) give them a key role in the control of&#xD;
      urination but also in the control of postural stability. These activities are involuntary&#xD;
      automatisms and the mechanisms that lead to post-prostatectomy stress urinary incontinence&#xD;
      are not only due to the loss of voluntary contraction of the pelvic floor muscles. The&#xD;
      mechanisms that lead to UI are more complex and may involve the loss of efficacy of all deep&#xD;
      muscle stabilizing lumbo-pelvic region. Rehabilitation of pelvic floor muscles is recommended&#xD;
      in the treatment of urinary incontinence after prostatectomy (Grade A), but there is a lack&#xD;
      of evidence to define the best treatment regimen for PFM rehabilitation.&#xD;
&#xD;
      Two kinds of PFM rehabilitation are are commonly practiced by specialized physiotherapists.&#xD;
&#xD;
        -  The first one is made in individual box, in supine position. By analytic contractions of&#xD;
           the PFM, (exercises of Kegel type) +/- associated with an instrumental biofeedback. This&#xD;
           method used voluntary contractions of MPP.&#xD;
&#xD;
        -  The second is realized in various positions following a gravity progression, in&#xD;
           individual and /or common room. This technique aims to restore a stabilization of the&#xD;
           entire lumbo-pelvic region by postural recruitment involving synergistic contractions of&#xD;
           the PFM.&#xD;
&#xD;
      These trials propose to compare these two rehabilitation programs on populations with&#xD;
      postoperative follow-up of more than 12 months.&#xD;
&#xD;
      We chose to objectify the urine leaks with the pad test (weighing of the protections urinary&#xD;
      over a period of 3 times 24h) which will be our main evaluation criterion. The home test pad&#xD;
      of 3 times in 24 hours has been used by numerous studies and its reproducibility and&#xD;
      reliability are established.&#xD;
&#xD;
      Urinary incontinence is a recognized factor of sedentary lifestyle, fatigue, impaired mental&#xD;
      health and decreased of physical fitness. We therefore wish to observe these parameters for&#xD;
      each of our two randomized groups&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 2018</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference from baseline in urine leakage</measure>
    <time_frame>6 months</time_frame>
    <description>urine leakage will be measured using pad test</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference from baseline in The Berg balance scale test</measure>
    <time_frame>6 months</time_frame>
    <description>The Berg balance scale test evaluating the quality of static and dynamic motor control.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference from baseline in quality of life</measure>
    <time_frame>6 months</time_frame>
    <description>quality of life is based on EORTC QLQ C30</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">116</enrollment>
  <condition>Urinary Incontinence</condition>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>postural rehabilitation program based on sensory-motor control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard physiotherapy</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>postural rehabilitation program</intervention_name>
    <description>This program is based on sensory-motor control</description>
    <arm_group_label>postural rehabilitation program based on sensory-motor control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Gender: Male&#xD;
&#xD;
          -  Between the age of 18 and 78 years&#xD;
&#xD;
          -  Patient who underwent prostatectomy more than 12 months ago but less than 10 years&#xD;
&#xD;
          -  3x24h pad test over or equivalent to 10 grs&#xD;
&#xD;
          -  Persistent urinary incontinence beyond 12 month following prostatectomy&#xD;
&#xD;
          -  Patient affiliated to social security&#xD;
&#xD;
          -  Patient who submitted non-opposition for participation in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who underwent prostatectomy or other visceral surgery less than one year ago&#xD;
&#xD;
          -  Patient who underwent surgical treatment of urinary incontinence&#xD;
&#xD;
          -  Patient with urinary incontinence less than 10g&#xD;
&#xD;
          -  Surgery considered within two years of inclusion&#xD;
&#xD;
          -  Radio, hormone, or chemotherapy cured or in progress&#xD;
&#xD;
          -  Anticholinergic treatment less than 3 months ago&#xD;
&#xD;
          -  Patient with neurological or bladder disorders potentially involved in incontinence&#xD;
             disorders&#xD;
&#xD;
          -  Vestibular or psychiatric pathology making limitations to carry out all the&#xD;
             examinations provided for in the protocol&#xD;
&#xD;
          -  Patient unable to complete the planned 15 visits to physiotherapist&#xD;
&#xD;
          -  Patient participating in another clinical trial&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>this medical condition for participation is patient with a prostatectomy</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>78 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Benoît STEENSTRUP</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rouen University Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Benoît STEENSTRUP</last_name>
    <phone>023288</phone>
    <phone_ext>8990</phone_ext>
    <email>benoit.steenstrup@orange.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Julien BLOT</last_name>
    <email>julien.blot@chu-rouen.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Rouen University Hospital</name>
      <address>
        <city>Rouen</city>
        <country>France</country>
      </address>
    </facility>
    <contact>
      <last_name>Benoit STEENSTRUP</last_name>
      <email>benoit.steenstrup@orange.fr</email>
    </contact>
    <investigator>
      <last_name>Jean-Nicolas CORNU, Pr</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>January 19, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 23, 2017</study_first_posted>
  <last_update_submitted>May 25, 2018</last_update_submitted>
  <last_update_submitted_qc>May 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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/NCT03027986
org study id: 2015/210/HP
nct id: NCT03027986
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Urinary incontinence (UI) is defined by the International Continence Society as "any
      involuntary loss of urine complained by the patient". The anatomical and histological
      specificities of the pelvic floor muscles (PFM) give them a key role in the control of
      urination but also in the control of postural stability. These activities are involuntary
      automatisms and the mechanisms that lead to post-prostatectomy stress urinary incontinence
      are not only due to the loss of voluntary contraction of the pelvic floor muscles. The
      mechanisms that lead to UI are more complex and may involve the loss of efficacy of all deep
      muscle stabilizing lumbo-pelvic region. Rehabilitation of pelvic floor muscles is recommended
      in the treatment of urinary incontinence after prostatectomy (Grade A), but there is a lack
      of evidence to define the best treatment regimen for PFM rehabilitation.

      Two kinds of PFM rehabilitation are are commonly practiced by specialized physiotherapists.

        -  The first one is made in individual box, in supine position. By analytic contractions of
           the PFM, (exercises of Kegel type) +/- associated with an instrumental biofeedback. This
           method used voluntary contractions of MPP.

        -  The second is realized in various positions following a gravity progression, in
           individual and /or common room. This technique aims to restore a stabilization of the
           entire lumbo-pelvic region by postural recruitment involving synergistic contractions of
           the PFM.

      These trials propose to compare these two rehabilitation programs on populations with
      postoperative follow-up of more than 12 months.

      We chose to objectify the urine leaks with the pad test (weighing of the protections urinary
      over a period of 3 times 24h) which will be our main evaluation criterion. The home test pad
      of 3 times in 24 hours has been used by numerous studies and its reproducibility and
      reliability are established.

      Urinary incontinence is a recognized factor of sedentary lifestyle, fatigue, impaired mental
      health and decreased of physical fitness. We therefore wish to observe these parameters for
      each of our two randomized groups
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Difference from baseline in urine leakage
time frame: 6 months
description: urine leakage will be measured using pad test
measure: Difference from baseline in The Berg balance scale test
time frame: 6 months
description: The Berg balance scale test evaluating the quality of static and dynamic motor control.
measure: Difference from baseline in quality of life
time frame: 6 months
description: quality of life is based on EORTC QLQ C30
arm group label: postural rehabilitation program based on sensory-motor control
arm group type: Experimental
arm group label: Standard physiotherapy
arm group type: No Intervention
intervention type: Behavioral
intervention name: postural rehabilitation program
description: This program is based on sensory-motor control
arm group label: postural rehabilitation program based on sensory-motor control
criteria: 
gender: Male
gender based: Yes
gender description: this medical condition for participation is patient with a prostatectomy
minimum age: 18 Years
maximum age: 78 Years
healthy volunteers: No
last name: Benoît STEENSTRUP
role: Principal Investigator
affiliation: Rouen University Hospital
last name: Benoît STEENSTRUP
phone: 023288
phone ext: 8990
email: benoit.steenstrup@orange.fr
last name: Julien BLOT
email: julien.blot@chu-rouen.fr
facility: 
contact: 
investigator: 
country: France
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
sharing ipd: No