<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/NCT04417413</url>
  </required_header>
  <id_info>
    <org_study_id>POP+SUI</org_study_id>
    <nct_id>NCT04417413</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy of Non-ablative Er:YAG Laser Therapy for the Treatment of Pelvic Organ Prolapse and Coexisting Stress Urinary Incontinence: A Retrospective Case Series.</brief_title>
  <official_title>Safety and Efficacy of Non-ablative Er:YAG Laser Therapy for the Treatment of Pelvic Organ Prolapse and Coexisting Stress Urinary Incontinence: A Retrospective Case Series.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aleksandra Novakov Mikic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poliklinika Novakov i saradnici</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 objective of the study is to retrospectively collect the data on patients who underwent&#xD;
      pelvic organ prolapse treatment using a non-ablative Er:YAG laser with SMOOTH mode and to&#xD;
      conduct an objective evaluation of safety and efficacy of Er:YAG laser treatment. In a group&#xD;
      of patients that have concomitant stress urinary incontinence symptoms, the effectiveness of&#xD;
      the treatments on these symptoms will be evaluated as well.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) affect many women and can&#xD;
      dramatically decrease their quality of life. Most of the patients diagnosed with stress&#xD;
      urinary incontinence also have a degree of pelvic organ prolapse and vice-versa.&#xD;
&#xD;
      One of the more promising new approaches in treating disorders connected to pelvic floor&#xD;
      dysfunction has been the introduction of vaginal erbium laser treatment for pelvic organ&#xD;
      prolapse.&#xD;
&#xD;
      The primary aim of the present retrospective study was toassess the effectiveness of vaginal&#xD;
      erbium laser with SMOOTH mode for the treatment of patients with pelvic organ prolapse and&#xD;
      co-existing stress urinary incontinence, if present.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Actual">December 31, 2019</completion_date>
  <primary_completion_date type="Actual">December 31, 2019</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cystocele stage</measure>
    <time_frame>Before and at all follow ups (up to 3 months after last treatment)</time_frame>
    <description>Assesment of POP grade using Baden-Walker scale</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Severity of stress urinary incontinence</measure>
    <time_frame>Before and at all follow ups (up to 3 months after last treatment)</time_frame>
    <description>assessment of SUI severity using ICIQ-UI questionnaire</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assesment of safety</measure>
    <time_frame>Before and at all follow ups (up to 3 months after last treatment)</time_frame>
    <description>Assesment of adverse effects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>Before and at all follow ups (up to 3 months after last treatment)</time_frame>
    <description>Assesment of patient satisfaction using 0-10 VAS scale</description>
  </secondary_outcome>
  <enrollment type="Actual">41</enrollment>
  <condition>Cystocele</condition>
  <condition>Pelvic Organ Prolapse</condition>
  <condition>Stress Urinary Incontinence</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fotona ProlapLase</intervention_name>
    <description>Non-ablative SMOOTH mode intravaginal Er:YAG teratment for pelvic organ prolapse</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients that had pelvic organ prolapse with or without concomitant stress urinary&#xD;
        incontinence and that were treated using non-ablative Fotona Er:YAG laser (ProlapLase&#xD;
        treatment) in the time period from 2015 to 2016 were included in this retrospective study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All patients that had pelvic organ prolapse with or without concomitant stress urinary&#xD;
        incontinence and that were treated using non-ablative Fotona Er:YAG laser (ProlapLase&#xD;
        treatment) in the time period from 2015 to 2016 will be included in this retrospective&#xD;
        study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients who failed to attend a follow-up appointment will be excluded from this&#xD;
        retrospective case series study.&#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>Poliklinika Novakov i sar.</name>
      <address>
        <city>Novi Sad</city>
        <zip>21000</zip>
        <country>Serbia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Serbia</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 2, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>November 11, 2020</last_update_submitted>
  <last_update_submitted_qc>November 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Poliklinika Novakov i saradnici</investigator_affiliation>
    <investigator_full_name>Aleksandra Novakov Mikic</investigator_full_name>
    <investigator_title>Prof Dr</investigator_title>
  </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>
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
    <mesh_term>Cystocele</mesh_term>
    <mesh_term>Prolapse</mesh_term>
    <mesh_term>Pelvic Organ Prolapse</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/NCT04417413
org study id: POP+SUI
nct id: NCT04417413
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The objective of the study is to retrospectively collect the data on patients who underwent
      pelvic organ prolapse treatment using a non-ablative Er:YAG laser with SMOOTH mode and to
      conduct an objective evaluation of safety and efficacy of Er:YAG laser treatment. In a group
      of patients that have concomitant stress urinary incontinence symptoms, the effectiveness of
      the treatments on these symptoms will be evaluated as well.
Pelvic organ prolapse (POP) and stress urinary incontinence (SUI) affect many women and can
      dramatically decrease their quality of life. Most of the patients diagnosed with stress
      urinary incontinence also have a degree of pelvic organ prolapse and vice-versa.

      One of the more promising new approaches in treating disorders connected to pelvic floor
      dysfunction has been the introduction of vaginal erbium laser treatment for pelvic organ
      prolapse.

      The primary aim of the present retrospective study was toassess the effectiveness of vaginal
      erbium laser with SMOOTH mode for the treatment of patients with pelvic organ prolapse and
      co-existing stress urinary incontinence, if present.
observational model: Cohort
time perspective: Retrospective
measure: Cystocele stage
time frame: Before and at all follow ups (up to 3 months after last treatment)
description: Assesment of POP grade using Baden-Walker scale
measure: Severity of stress urinary incontinence
time frame: Before and at all follow ups (up to 3 months after last treatment)
description: assessment of SUI severity using ICIQ-UI questionnaire
measure: Assesment of safety
time frame: Before and at all follow ups (up to 3 months after last treatment)
description: Assesment of adverse effects
measure: Patient satisfaction
time frame: Before and at all follow ups (up to 3 months after last treatment)
description: Assesment of patient satisfaction using 0-10 VAS scale
intervention type: Device
intervention name: Fotona ProlapLase
description: Non-ablative SMOOTH mode intravaginal Er:YAG teratment for pelvic organ prolapse
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Serbia
responsible party type: Sponsor-Investigator
investigator affiliation: Poliklinika Novakov i saradnici
investigator full name: Aleksandra Novakov Mikic
investigator title: Prof Dr
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
mesh term: Cystocele
mesh term: Prolapse
mesh term: Pelvic Organ Prolapse
sharing ipd: No