<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/NCT03228485</url>
  </required_header>
  <id_info>
    <org_study_id>uCARE-2018-002</org_study_id>
    <nct_id>NCT03228485</nct_id>
  </id_info>
  <brief_title>Benign Prostatic Hyperplasia (BPH) Mobile Application Pilot Study</brief_title>
  <official_title>The Feasibility and Acceptability of a (Mobile) Application for Men With LUTS/BPH: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Société Internationale d'Urologie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Société Internationale d'Urologie</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 assesses the feasibility, and acceptability of a (mobile) application for men&#xD;
      presenting at their physician's office with LUTS/BPH; starting with medical therapy and naïve&#xD;
      for treatment. Patients will be enrolled in the study by their physician (GP or urologist).&#xD;
      The patients will receive a daily medication reminder including frequent feedback on&#xD;
      medication adherence. Furthermore, standard questionnaires will be filled out via the&#xD;
      application. The hypothesis of this pilot study is that application is feasible and accepted&#xD;
      in this group of patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale:&#xD;
&#xD;
      One of the next developments in healthcare is digitalization, including (mobile) applications&#xD;
      that could support healthcare providers. A significant number of aging men suffer from lower&#xD;
      urinary tract symptoms (LUTS), often caused by benign prostate hyperplasia (BPH). LUTS/BPH is&#xD;
      primarily treated by physicians (GPs or Urologists). Optimal evaluation of patients with&#xD;
      LUTS/BPH, treatment selection and follow-up by the physicians and medication adherence are&#xD;
      essential in the management of LUTS. This pilot project represents a strong collaboration&#xD;
      between a urological association, urologists, and physicians in supporting healthcare&#xD;
      improvement for LUTS/BPH with the use of a (mobile) application. The hypothesis is that the&#xD;
      (mobile) application can support the patient in medication adherence and improve the&#xD;
      adherence by feedback and that the application can help to collect objective disease&#xD;
      information with electronic questionnaires.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
      The primary objective is to assess the feasibility, and acceptability of a (mobile)&#xD;
      application for men presenting at their general practitioner/or urologist with LUTS/BPH who&#xD;
      are either: under treatment, or who may require medical therapy for the first time.&#xD;
&#xD;
      The secondary objectives are to identify potential gaps, clarify controversial points of the&#xD;
      application, to document the communication between patients, physicians and supervising&#xD;
      urologists in order to optimize (if necessary) the application, to assess medication&#xD;
      adherence and to record if treatment provided by physicians is in compliance with the&#xD;
      guidelines recommendations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 4, 2019</start_date>
  <completion_date type="Anticipated">April 10, 2021</completion_date>
  <primary_completion_date type="Anticipated">April 10, 2021</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>Feasibility of a mobile application for LUTS</measure>
    <time_frame>6 months</time_frame>
    <description>The feasibility is assessed by the application use for men presenting at their general practitioner/or urologist with LUTS/BPH who are either: under treatment, or who may require medical therapy for the first time. The patient application will be judged as Definitely Feasible if the study is completed for ≥70% eligible patients, Possibly Feasible (completed for 50-69% eligible patients) or Not Feasible (completed for &lt;50%).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Acceptability and satisfaction of a mobile application for LUTS</measure>
    <time_frame>6 months</time_frame>
    <description>In order to assess the acceptance and satisfaction of the mobile application including the application subjective quality and perceived impact, a questionnaire will be used. This questionnaire is based on a standardized application rating questionnaire, namely the user Mobile Application Rating Scale (uMARS). Outcomes are described and compared between centers.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication adherence</measure>
    <time_frame>6 months</time_frame>
    <description>Self-reported medication adherence by the patient via the application over the full period of the pilot.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance to guidelines</measure>
    <time_frame>At baseline</time_frame>
    <description>Descriptive comparison between the medication prescribed by the physician and the advised medication according to the international guidelines based on the patient characteristics.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Referral network</measure>
    <time_frame>At the end of the 6 months period</time_frame>
    <description>Evaluation of the referral communication between the physicians and the supervising urologist by questions in the final questionnaire.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Prostatic Hyperplasia</condition>
  <condition>Lower Urinary Tract Symptoms</condition>
  <arm_group>
    <arm_group_label>MyBPH Care</arm_group_label>
    <description>All patients enrolled in this study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MyBPH Care mobile app</intervention_name>
    <description>The application that will give daily medication reminders and via which the questionnaires can be filled out.</description>
    <arm_group_label>MyBPH Care</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The population will be men, age ≥ 40, presenting at their physician's office with LUTS/BPH&#xD;
        symptoms and are either: a) treatment naïve for LUTS/BPH or b) under medical treatment.&#xD;
&#xD;
        The study will be conducted by five centers in five countries: Institute for Monitoring of&#xD;
        Urogenital Diseases in Larissa, Greece, the Istanbul Medipol University in Turkey, the&#xD;
        Hospital Universitario la Zarzuela in Spain, the Hospital de San António in Portugal, and&#xD;
        the University of Florence in Italy. The participating physicians will be from these areas&#xD;
        and thus so will the participants.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male&#xD;
&#xD;
          -  Age ≥ 40&#xD;
&#xD;
          -  Bothersome LUTS&#xD;
&#xD;
          -  Start of medical therapy for LUTS&#xD;
&#xD;
          -  Either:&#xD;
&#xD;
               1. No previous LUTS/BPH treatment (medical or invasive), or&#xD;
&#xD;
               2. Under medical treatment&#xD;
&#xD;
          -  In possession of a smartphone, tablet or computer with internet connection&#xD;
&#xD;
          -  Access to email&#xD;
&#xD;
          -  Fluent speaking and reading of the national language&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous LUTS/BPH treatment with surgery&#xD;
&#xD;
          -  Previous pelvic surgery or radiotherapy&#xD;
&#xD;
          -  History of neurological disease&#xD;
&#xD;
          -  History of bladder or prostate cancer&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  Analphabet&#xD;
&#xD;
          -  Unable to operate a smartphone/ tablet/computer&#xD;
&#xD;
          -  Incapable of understanding the language in which the information for the patient is&#xD;
             given&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stavros Gravas, MD</last_name>
    <role>Study Chair</role>
    <affiliation>Societe Internationale d'Urologie</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Stavros Gravas, MD</last_name>
    <phone>+30-2413 502983</phone>
    <email>sgravas2002@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jean de la Rosette, MD, PhD</last_name>
    <email>j.j.delarosette@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University Hospital of Larissa, Institute for Monitoring of Urogenital Diseases</name>
      <address>
        <city>Larissa</city>
        <zip>10</zip>
        <country>Greece</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>S Gravas, Dr.</last_name>
      <phone>+30-2413 502983</phone>
      <email>sgravas2002@yahoo.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>University of Florence</name>
      <address>
        <city>Florence</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Mauro Gacci, MD</last_name>
      <email>maurogacci@yahoo.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital de Santo Antonio</name>
      <address>
        <city>Porto</city>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Vitor Cavadas, MD</last_name>
      <email>vcavadas@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario la Zarzuela</name>
      <address>
        <city>Madrid</city>
        <zip>28023</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Ignacio Moncada Iribarren, Prof. Dr.</last_name>
      <email>ignacio@moncada.name</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Istanbul Medipol University</name>
      <address>
        <city>Istanbul</city>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean J de la Rosette, Prof. dr.</last_name>
      <email>j.j.delarosette@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Selçuk Guven, MD</last_name>
      <email>selcukguven@hotmail.com</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Greece</country>
    <country>Italy</country>
    <country>Portugal</country>
    <country>Spain</country>
    <country>Turkey</country>
  </location_countries>
  <removed_countries>
    <country>Netherlands</country>
  </removed_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>July 20, 2017</study_first_submitted>
  <study_first_submitted_qc>July 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 25, 2017</study_first_posted>
  <last_update_submitted>April 29, 2020</last_update_submitted>
  <last_update_submitted_qc>April 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 1, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Smartphone</keyword>
  <keyword>Application</keyword>
  <keyword>Pilot</keyword>
  <keyword>mhealth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
    <mesh_term>Lower Urinary Tract Symptoms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03228485
org study id: uCARE-2018-002
nct id: NCT03228485
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study assesses the feasibility, and acceptability of a (mobile) application for men
      presenting at their physician's office with LUTS/BPH; starting with medical therapy and naïve
      for treatment. Patients will be enrolled in the study by their physician (GP or urologist).
      The patients will receive a daily medication reminder including frequent feedback on
      medication adherence. Furthermore, standard questionnaires will be filled out via the
      application. The hypothesis of this pilot study is that application is feasible and accepted
      in this group of patients.
Rationale:

      One of the next developments in healthcare is digitalization, including (mobile) applications
      that could support healthcare providers. A significant number of aging men suffer from lower
      urinary tract symptoms (LUTS), often caused by benign prostate hyperplasia (BPH). LUTS/BPH is
      primarily treated by physicians (GPs or Urologists). Optimal evaluation of patients with
      LUTS/BPH, treatment selection and follow-up by the physicians and medication adherence are
      essential in the management of LUTS. This pilot project represents a strong collaboration
      between a urological association, urologists, and physicians in supporting healthcare
      improvement for LUTS/BPH with the use of a (mobile) application. The hypothesis is that the
      (mobile) application can support the patient in medication adherence and improve the
      adherence by feedback and that the application can help to collect objective disease
      information with electronic questionnaires.

      Objectives:

      The primary objective is to assess the feasibility, and acceptability of a (mobile)
      application for men presenting at their general practitioner/or urologist with LUTS/BPH who
      are either: under treatment, or who may require medical therapy for the first time.

      The secondary objectives are to identify potential gaps, clarify controversial points of the
      application, to document the communication between patients, physicians and supervising
      urologists in order to optimize (if necessary) the application, to assess medication
      adherence and to record if treatment provided by physicians is in compliance with the
      guidelines recommendations.
observational model: Cohort
time perspective: Prospective
measure: Feasibility of a mobile application for LUTS
time frame: 6 months
description: The feasibility is assessed by the application use for men presenting at their general practitioner/or urologist with LUTS/BPH who are either: under treatment, or who may require medical therapy for the first time. The patient application will be judged as Definitely Feasible if the study is completed for ≥70% eligible patients, Possibly Feasible (completed for 50-69% eligible patients) or Not Feasible (completed for <50%).
measure: Acceptability and satisfaction of a mobile application for LUTS
time frame: 6 months
description: In order to assess the acceptance and satisfaction of the mobile application including the application subjective quality and perceived impact, a questionnaire will be used. This questionnaire is based on a standardized application rating questionnaire, namely the user Mobile Application Rating Scale (uMARS). Outcomes are described and compared between centers.
measure: Medication adherence
time frame: 6 months
description: Self-reported medication adherence by the patient via the application over the full period of the pilot.
measure: Compliance to guidelines
time frame: At baseline
description: Descriptive comparison between the medication prescribed by the physician and the advised medication according to the international guidelines based on the patient characteristics.
measure: Referral network
time frame: At the end of the 6 months period
description: Evaluation of the referral communication between the physicians and the supervising urologist by questions in the final questionnaire.
arm group label: MyBPH Care
description: All patients enrolled in this study.
intervention type: Device
intervention name: MyBPH Care mobile app
description: The application that will give daily medication reminders and via which the questionnaires can be filled out.
arm group label: MyBPH Care
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Male
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Stavros Gravas, MD
role: Study Chair
affiliation: Societe Internationale d'Urologie
last name: Stavros Gravas, MD
phone: +30-2413 502983
email: sgravas2002@yahoo.com
last name: Jean de la Rosette, MD, PhD
email: j.j.delarosette@gmail.com
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
contact backup: 
country: Greece
country: Italy
country: Portugal
country: Spain
country: Turkey
country: Netherlands
responsible party type: Sponsor
mesh term: Prostatic Hyperplasia
mesh term: Hyperplasia
mesh term: Lower Urinary Tract Symptoms
sharing ipd: Undecided