<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/NCT03267719</url>
  </required_header>
  <id_info>
    <org_study_id>Uro-Laser</org_study_id>
    <nct_id>NCT03267719</nct_id>
  </id_info>
  <brief_title>Intravaginal Laser Treatment of Mild and Moderate Stress Incontinence</brief_title>
  <acronym>laser</acronym>
  <official_title>Intravaginal Laser Treatment of Mild and Moderate Stress Incontinence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Women's Hospital Tübingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Women's Hospital Tübingen</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>
      The aim of the study is to evaluate the effectiveness of laser therapy as a non-surgical&#xD;
      treatment option in patients with mild and moderate stress incontinence.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of the study is to evaluate the effectiveness of laser therapy as a non-surgical&#xD;
      treatment option in patients with mild and moderate stress incontinence.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 31, 2017</start_date>
  <completion_date type="Actual">September 1, 2018</completion_date>
  <primary_completion_date type="Actual">March 1, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quality of life</measure>
    <time_frame>6 month</time_frame>
    <description>Quality of life will be access via ICIQ-SF questionaire</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Stress Incontinence, Female</condition>
  <arm_group>
    <arm_group_label>laser therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Erbium-laser therapy will be applied</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>laser therapy</intervention_name>
    <description>Transvaginal erbium-laser treatment</description>
    <arm_group_label>laser therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Light or moderate stress incontinence&#xD;
&#xD;
          -  mixed urine incontinence with predominance of the stress component&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  patients treated radiotherapy in the small basin&#xD;
&#xD;
          -  connective tissue disorders (e.g., Ehlers-Danlos syndrome, Marfan syndrome)&#xD;
&#xD;
          -  patient with or after malignant disease of the uterus, ovaries, vagina and vulva&#xD;
&#xD;
          -  former surgery due to stress incontinence (except for the patients who had a TVT&#xD;
             insert with removal of the TVT)&#xD;
&#xD;
          -  Descensus genitalis&gt; POPQ Stage 1&#xD;
&#xD;
          -  former surgery due to a genital lowering with vaginal netting&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christl Reisenauer, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Women's Hospital Tübingen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department for Women's Health</name>
      <address>
        <city>Tübingen</city>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>August 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>March 5, 2019</last_update_submitted>
  <last_update_submitted_qc>March 5, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 6, 2019</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, Stress</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/NCT03267719
org study id: Uro-Laser
nct id: NCT03267719
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to evaluate the effectiveness of laser therapy as a non-surgical
      treatment option in patients with mild and moderate stress incontinence.
The aim of the study is to evaluate the effectiveness of laser therapy as a non-surgical
      treatment option in patients with mild and moderate stress incontinence.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Quality of life
time frame: 6 month
description: Quality of life will be access via ICIQ-SF questionaire
arm group label: laser therapy
arm group type: Experimental
description: Erbium-laser therapy will be applied
intervention type: Device
intervention name: laser therapy
description: Transvaginal erbium-laser treatment
arm group label: laser therapy
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Christl Reisenauer, Prof. Dr.
role: Principal Investigator
affiliation: University Women's Hospital Tübingen
facility: 
country: Germany
responsible party type: Sponsor
mesh term: Urinary Incontinence, Stress
sharing ipd: No