xml: <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/NCT06031870</url>
    </required_header>
    <id_info>
      <org_study_id>2018-13832</org_study_id>
      <nct_id>NCT06031870</nct_id>
    </id_info>
    <brief_title>Pelvic Floor Rehabilitation Study (Beckenboden-Rehabilitationsstudie - BREST)</brief_title>
    <official_title>Beckenboden-Rehabilitationsstudie (BREST)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Medical University of Vienna</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Medical University of Vienna</source>
    <oversight_info>
      <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 compares the effectiveness of standard care, pelvic floor muscle training or&#xD;
        vaginal pessary for the treatment of postpartum urinary incontinence.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">September 1, 2018</start_date>
    <completion_date type="Actual">August 31, 2021</completion_date>
    <primary_completion_date type="Actual">April 30, 2021</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>patients' self-reported satisfaction with the treatment</measure>
      <time_frame>12 weeks</time_frame>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">52</enrollment>
    <condition>Postpartum Urinary Incontinence</condition>
    <arm_group>
      <arm_group_label>Standard care</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Pelvic floor muscle training</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Vaginal pessary</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Vaginal pessary</intervention_name>
      <description>In the pessary group, all patients received a cube pessary, which was individually adapted to each patient. These pessaries exist in sizes 0 (25 mm edge length) to 9 (75 mm edge length). Patients were instructed by a physician or a trained nurse on how to autonomously manage the pessary, including daily changing and cleaning. After one week of treatment, all patients had an office visit to check if fitting was correct and if autonomous handling of the pessary was feasible. Treatment duration was 12 weeks.</description>
      <arm_group_label>Vaginal pessary</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Standard care</intervention_name>
      <description>Standard care consisted of a pelvic floor group exercise course led by a midwife, a physiotherapist, or an osteopath. Courses were in general once a week for a minimum of seven to a maximum of twelve weeks. The course was chosen by the patient, and the study team had no influence on the choice.</description>
      <arm_group_label>Standard care</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Pelvic floor muscle training</intervention_name>
      <description>Twelve pelvic floor physiotherapy sessions were prescribed by the study physician. Pelvic floor physiotherapy was performed in individual courses by trained physiotherapists. The patient was free to choose the physiotherapist and the study team had no influence on the choice.</description>
      <arm_group_label>Pelvic floor muscle training</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  18 years or older&#xD;
  &#xD;
            -  gave birth within the 12 weeks prior to the postpartum visit&#xD;
  &#xD;
            -  postpartum urinary incontinence&#xD;
  &#xD;
            -  able to understand and give consent in German&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  treatment for postpartum urinary incontinence that started prior to inclusion&#xD;
  &#xD;
            -  any neurologic disease that impairs bladder function&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Die GynPraxis</name>
        <address>
          <city>Alzey</city>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Die GynPraxis</name>
        <address>
          <city>Bad Kreuznach</city>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Die GynPraxis</name>
        <address>
          <city>Lampertheim</city>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Die GynPraxis</name>
        <address>
          <city>Mainz</city>
          <country>Germany</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Germany</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 4, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 11, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Medical University of Vienna</investigator_affiliation>
      <investigator_full_name>Soren Lange</investigator_full_name>
      <investigator_title>M.D.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urinary Incontinence</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06031870
  org study id: 2018-13832
  nct id: NCT06031870
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  This study compares the effectiveness of standard care, pelvic floor muscle training or
        vaginal pessary for the treatment of postpartum urinary incontinence.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: patients' self-reported satisfaction with the treatment
  time frame: 12 weeks
  arm group label: Standard care
  arm group type: Active Comparator
  arm group label: Pelvic floor muscle training
  arm group type: Active Comparator
  arm group label: Vaginal pessary
  arm group type: Experimental
  intervention type: Device
  intervention name: Vaginal pessary
  description: In the pessary group, all patients received a cube pessary, which was individually adapted to each patient. These pessaries exist in sizes 0 (25 mm edge length) to 9 (75 mm edge length). Patients were instructed by a physician or a trained nurse on how to autonomously manage the pessary, including daily changing and cleaning. After one week of treatment, all patients had an office visit to check if fitting was correct and if autonomous handling of the pessary was feasible. Treatment duration was 12 weeks.
  arm group label: Vaginal pessary
  intervention type: Behavioral
  intervention name: Standard care
  description: Standard care consisted of a pelvic floor group exercise course led by a midwife, a physiotherapist, or an osteopath. Courses were in general once a week for a minimum of seven to a maximum of twelve weeks. The course was chosen by the patient, and the study team had no influence on the choice.
  arm group label: Standard care
  intervention type: Procedure
  intervention name: Pelvic floor muscle training
  description: Twelve pelvic floor physiotherapy sessions were prescribed by the study physician. Pelvic floor physiotherapy was performed in individual courses by trained physiotherapists. The patient was free to choose the physiotherapist and the study team had no influence on the choice.
  arm group label: Pelvic floor muscle training
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  facility: 
  facility: 
  country: Germany
  responsible party type: Principal Investigator
  investigator affiliation: Medical University of Vienna
  investigator full name: Soren Lange
  investigator title: M.D.
  mesh term: Urinary Incontinence
  sharing ipd: Undecided