<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/NCT03255421</url>
  </required_header>
  <id_info>
    <org_study_id>P GREEN 01</org_study_id>
    <nct_id>NCT03255421</nct_id>
  </id_info>
  <brief_title>Filling and Emptying Cystometries (&quot;Backwards Cystometry&quot;): a Feasibility and Validation Study</brief_title>
  <official_title>Filling and Emptying Cystometries: a Feasibility and Validation Study in Order to Simplify the Manometric Follow-up of Overactive Detrusor in Neurological Patients Under Anticholinergic or Botulinum Toxin Injections.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pierre and Marie Curie University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pierre and Marie Curie University</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 study evaluate the feasibility and the accuracy of an emptying cystometry in order to&#xD;
      simplify the manometric follow-up of overactive detrusor in neurological patients under&#xD;
      anticholinergic or botulinum toxin injections.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Bladder pressure assessment is necessary for the diagnosis, the prognostic assessment and the&#xD;
      management of neurogenic bladder. High bladder pressures increase the rate of urological&#xD;
      complications and mortality in patients with neurogenic bladder. Thus many treatments are&#xD;
      proposed in order to improve bladder compliance and reduce uninhibited detrusor contractions&#xD;
      (anticholinergic drugs, botulinum toxin injections, cystoplasty, sacral neuromodulation,&#xD;
      beta-3-agonist, posterior tibial nerve stimulation).&#xD;
&#xD;
      Clinical data, symptoms scales, quality of life questionnaires, renal ultrasound, biological&#xD;
      tests of renal function and urodynamic studies are used to control the treatment efficacy of&#xD;
      neurogenic lower urinary tract dysfunction. Filling cystometry is the usual way to record&#xD;
      bladder pressure. Urodynamic techniques using external pressure transducers (microtip,&#xD;
      air-filled or fluid-perfused catheters) connected to the patient with fluid-filled lines are&#xD;
      recommended. This multichannel cystometry is performed in a specialized department with the&#xD;
      inconvenience of delays for appointments and cost of the urodynamic assessment. Moreover,&#xD;
      only some parameters are important and are taken in account in the follow-up of these&#xD;
      neurogenic bladders: bladder capacity, bladder compliance and maximum detrusor pressure at&#xD;
      the end of the filling phase. All these parameters can be recorded with a self-assessment of&#xD;
      bladder pressure at home with a very simple device made of 1) a self-intermittent catheter;&#xD;
      2) a three way stopcock; 3) a simple graduated tube. This device has in fact been used in the&#xD;
      past to realize cystometries, in particular in the elderly subject. A such device should&#xD;
      provide a monitoring in changes in bladder pressure in order to initiate adjustments in&#xD;
      treatment sooner than would be achieved when patients are evaluated periodically but less&#xD;
      frequently in the neurourology department. The early detection of high bladder pressures may&#xD;
      avoid bladder deformation, reflux and upper tract deterioration. Moreover, the home control&#xD;
      of appropriate bladder pressure may improve the patients' quality of live by reducing the&#xD;
      constraint linked to the time-consuming specialized follow-up.&#xD;
&#xD;
      In this study, the investigators will test a reverse single channel cystometry performed just&#xD;
      after a classical filling cystometry during the usual emptying by means of a device allowing&#xD;
      serial bladder pressure measurements during the bladder emptying. In case of such a&#xD;
      feasibility and a good precision of the reverse cystometry, the manometric follow-up of&#xD;
      overactive detrusor in neurological patients under anticholinergic or botulinum toxin&#xD;
      injections could be simplified.&#xD;
&#xD;
      The aim of this study is to assess the feasibility and the accuracy of sequential&#xD;
      measurements of bladder pressure during the bladder emptying and to compare the evolution of&#xD;
      bladder pressures during the emptying phase with the bladder pressures recorded during the&#xD;
      filling phase.&#xD;
&#xD;
      Patients over 18 years old, consulting for lower urinary tract symptoms and performing an&#xD;
      urodynamic examination with a cystometry in a tertiary center are included.&#xD;
&#xD;
      History, treatment and urodynamics data are recorded. Conventional supine multichannel&#xD;
      cystometry with isotonic saline infused at 50ml/min (filling cystometry), conform to the&#xD;
      International Continence Society (ICS) recommendations will be performed. At the end of the&#xD;
      standard cystometry when the maximum cystometric capacity will be reached, if no micturition&#xD;
      was obtained, urodynamic catheter was withdrawn and a CH12 urinary catheter will be&#xD;
      introduced in the bladder according to the usual department procedure (usually, this catheter&#xD;
      allows to empty the bladder). This catheter will be connected to a three-way stopcock. The&#xD;
      second way of the stopcock will permit the emptying into a measuring container, graduated&#xD;
      each 50ml. The third way of the stopcock will be connected via a tube extension to a rigid&#xD;
      vertical 70cm tube (central venous pressure set) graduated each centimeter. The zero pressure&#xD;
      of the vertical tube will be set at the upper edge of the symphysis pubis. For measuring the&#xD;
      bladder pressure at the maximum cystometric capacity, the valve will be open between the&#xD;
      bladder and the graduated tube, manometric data will be derived by observing the rise of the&#xD;
      column of fluid in the centimeter scale tube. This procedure will be repeated every 50ml&#xD;
      until bladder full emptying.&#xD;
&#xD;
      The investigators will compared each bladder pressure measures every 50ml during the&#xD;
      &quot;backwards cystometry&quot; with each bladder pressure measured every 50ml from the maximum&#xD;
      capacity during the filling cystometry.&#xD;
&#xD;
      Primary outcome is the agreement between the two cystometries evaluated using a kappa&#xD;
      coefficient.&#xD;
&#xD;
      Secondary outcome is the correlation between the pressures during the two cystometries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 31, 2017</start_date>
  <completion_date type="Actual">September 29, 2017</completion_date>
  <primary_completion_date type="Actual">August 28, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Agreement</measure>
    <time_frame>1 Day : during the urodynamic assessment</time_frame>
    <description>Agreement between the two cystometries evaluated using a kappa coefficient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Correlation</measure>
    <time_frame>1 Day : during the urodynamic assessment</time_frame>
    <description>Correlation between the pressures during the two cystometries.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">11</enrollment>
  <condition>Lower Urinary Tract Symptoms</condition>
  <arm_group>
    <arm_group_label>Patients enrolled</arm_group_label>
    <description>Patients over 18 years old, consulting for lower urinary tract symptoms and performing an urodynamic examination with a cystometry in a tertiary center are included.&#xD;
First pressure measurement in the bladder during the classic cystometry. Second measurement of bladder pressures during the bladder emptying.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Pressure measurement</intervention_name>
    <description>Observational study No intervention, only fragmenting the emptying of the bladder</description>
    <arm_group_label>Patients enrolled</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients consulting for an urodynamic assessment in a tertiary center in neuro-urology&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Follow in neuro-urology for lower urinary tract symptoms&#xD;
&#xD;
          -  Appointment for urodynamic assessment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  detrusor overactivity&#xD;
&#xD;
          -  micturition during or at the end of the filling cystometry&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gérard Amarenco, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>GREEN GRC-01, Neuro-urology, hôpital Tenon</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Neuro-urology, Tenon hospital</name>
      <address>
        <city>Paris</city>
        <zip>75020</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>August 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>September 24, 2019</last_update_submitted>
  <last_update_submitted_qc>September 24, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pierre and Marie Curie University</investigator_affiliation>
    <investigator_full_name>Gérard Amarenco</investigator_full_name>
    <investigator_title>Head of Neuro-Urology department, Tenon hospital</investigator_title>
  </responsible_party>
  <keyword>urodynamic</keyword>
  <keyword>backwards cystometry</keyword>
  <keyword>reverse cystometry</keyword>
  <keyword>follow-up</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lower Urinary Tract Symptoms</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/NCT03255421
org study id: P GREEN 01
nct id: NCT03255421
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluate the feasibility and the accuracy of an emptying cystometry in order to
      simplify the manometric follow-up of overactive detrusor in neurological patients under
      anticholinergic or botulinum toxin injections.
Bladder pressure assessment is necessary for the diagnosis, the prognostic assessment and the
      management of neurogenic bladder. High bladder pressures increase the rate of urological
      complications and mortality in patients with neurogenic bladder. Thus many treatments are
      proposed in order to improve bladder compliance and reduce uninhibited detrusor contractions
      (anticholinergic drugs, botulinum toxin injections, cystoplasty, sacral neuromodulation,
      beta-3-agonist, posterior tibial nerve stimulation).

      Clinical data, symptoms scales, quality of life questionnaires, renal ultrasound, biological
      tests of renal function and urodynamic studies are used to control the treatment efficacy of
      neurogenic lower urinary tract dysfunction. Filling cystometry is the usual way to record
      bladder pressure. Urodynamic techniques using external pressure transducers (microtip,
      air-filled or fluid-perfused catheters) connected to the patient with fluid-filled lines are
      recommended. This multichannel cystometry is performed in a specialized department with the
      inconvenience of delays for appointments and cost of the urodynamic assessment. Moreover,
      only some parameters are important and are taken in account in the follow-up of these
      neurogenic bladders: bladder capacity, bladder compliance and maximum detrusor pressure at
      the end of the filling phase. All these parameters can be recorded with a self-assessment of
      bladder pressure at home with a very simple device made of 1) a self-intermittent catheter;
      2) a three way stopcock; 3) a simple graduated tube. This device has in fact been used in the
      past to realize cystometries, in particular in the elderly subject. A such device should
      provide a monitoring in changes in bladder pressure in order to initiate adjustments in
      treatment sooner than would be achieved when patients are evaluated periodically but less
      frequently in the neurourology department. The early detection of high bladder pressures may
      avoid bladder deformation, reflux and upper tract deterioration. Moreover, the home control
      of appropriate bladder pressure may improve the patients' quality of live by reducing the
      constraint linked to the time-consuming specialized follow-up.

      In this study, the investigators will test a reverse single channel cystometry performed just
      after a classical filling cystometry during the usual emptying by means of a device allowing
      serial bladder pressure measurements during the bladder emptying. In case of such a
      feasibility and a good precision of the reverse cystometry, the manometric follow-up of
      overactive detrusor in neurological patients under anticholinergic or botulinum toxin
      injections could be simplified.

      The aim of this study is to assess the feasibility and the accuracy of sequential
      measurements of bladder pressure during the bladder emptying and to compare the evolution of
      bladder pressures during the emptying phase with the bladder pressures recorded during the
      filling phase.

      Patients over 18 years old, consulting for lower urinary tract symptoms and performing an
      urodynamic examination with a cystometry in a tertiary center are included.

      History, treatment and urodynamics data are recorded. Conventional supine multichannel
      cystometry with isotonic saline infused at 50ml/min (filling cystometry), conform to the
      International Continence Society (ICS) recommendations will be performed. At the end of the
      standard cystometry when the maximum cystometric capacity will be reached, if no micturition
      was obtained, urodynamic catheter was withdrawn and a CH12 urinary catheter will be
      introduced in the bladder according to the usual department procedure (usually, this catheter
      allows to empty the bladder). This catheter will be connected to a three-way stopcock. The
      second way of the stopcock will permit the emptying into a measuring container, graduated
      each 50ml. The third way of the stopcock will be connected via a tube extension to a rigid
      vertical 70cm tube (central venous pressure set) graduated each centimeter. The zero pressure
      of the vertical tube will be set at the upper edge of the symphysis pubis. For measuring the
      bladder pressure at the maximum cystometric capacity, the valve will be open between the
      bladder and the graduated tube, manometric data will be derived by observing the rise of the
      column of fluid in the centimeter scale tube. This procedure will be repeated every 50ml
      until bladder full emptying.

      The investigators will compared each bladder pressure measures every 50ml during the
      "backwards cystometry" with each bladder pressure measured every 50ml from the maximum
      capacity during the filling cystometry.

      Primary outcome is the agreement between the two cystometries evaluated using a kappa
      coefficient.

      Secondary outcome is the correlation between the pressures during the two cystometries.
observational model: Cohort
time perspective: Prospective
measure: Agreement
time frame: 1 Day : during the urodynamic assessment
description: Agreement between the two cystometries evaluated using a kappa coefficient.
measure: Correlation
time frame: 1 Day : during the urodynamic assessment
description: Correlation between the pressures during the two cystometries.
arm group label: Patients enrolled
description: Patients over 18 years old, consulting for lower urinary tract symptoms and performing an urodynamic examination with a cystometry in a tertiary center are included.
First pressure measurement in the bladder during the classic cystometry. Second measurement of bladder pressures during the bladder emptying.
intervention type: Other
intervention name: Pressure measurement
description: Observational study No intervention, only fragmenting the emptying of the bladder
arm group label: Patients enrolled
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gérard Amarenco, PhD
role: Principal Investigator
affiliation: GREEN GRC-01, Neuro-urology, hôpital Tenon
facility: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Pierre and Marie Curie University
investigator full name: Gérard Amarenco
investigator title: Head of Neuro-Urology department, Tenon hospital
mesh term: Lower Urinary Tract Symptoms