<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/NCT03296241</url>
  </required_header>
  <id_info>
    <org_study_id>SUI_ErYAG_Sham</org_study_id>
    <nct_id>NCT03296241</nct_id>
  </id_info>
  <brief_title>Non-ablative Er:Yttrium Aluminum Garnet Laser for Stress Urinary Incontinence (SUI)</brief_title>
  <official_title>Non-ablative Er:Yttrium Aluminum Garnet (Er:YAG) Laser Therapy Effect on Stress Urinary Incontinence (SUI) Related Quality of Life and Sexual Function: a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dr Adolf Lukanovič</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Centre Ljubljana</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>
      Stress urinary incontinence (SUI) is a common complaint in women after childbirth. The aim of&#xD;
      this study was to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy in&#xD;
      the treatment of SUI and improvement of sexual gratification in parous women. 114&#xD;
      premenopausal parous women with SUI were randomized in two groups of 57 women; a laser&#xD;
      intervention group and sham control (placebo) group. Both groups were treated according to&#xD;
      the IncontiLaseTM clinical treatment protocol for SUI with non-ablative thermal-only Er:YAG&#xD;
      laser, except that there was no energy output when treating the sham group. Patients were&#xD;
      blinded to the allocation. At baseline and 3 months after treatment patients were clinically&#xD;
      examined, answered questionnaires for SUI severity sexual function assessment and their&#xD;
      pelvic floor muscle (PFM) function was assessed with perineometry. The improvement in the&#xD;
      laser group will be compared to the improvement in the sham group.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Stress urinary incontinence (SUI) is a common complaint in women after childbirth. It affects&#xD;
      their quality of life and sexual satisfaction and is one of the major reasons for&#xD;
      gynaecological surgery. There is a need for effective non-invasive treatment alternatives.&#xD;
      The aim of this study was to evaluate the efficacy and safety of non-ablative Er:YAG laser&#xD;
      therapy in the treatment of SUI and improvement of sexual gratification in parous women. 114&#xD;
      premenopausal parous women with SUI were randomized in two groups of 57 women; a laser&#xD;
      intervention group and sham control (placebo) group. Both groups were treated according to&#xD;
      the IncontiLaseTM clinical treatment protocol for SUI with non-ablative thermal-only Er:YAG&#xD;
      laser, except that there was no energy output when treating the sham group. Patients were&#xD;
      blinded to the allocation. At baseline and 3 months after treatment patients were clinically&#xD;
      examined, answered questionnaires for SUI severity sexual function assessment and their&#xD;
      pelvic floor muscle (PFM) function was assessed with perineometry. Validated International&#xD;
      Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) was&#xD;
      used as the primary outcome measure. The Pelvic Organ Prolapse Urinary Incontinence Sexual&#xD;
      Questionnaire short form (PISQ-12) and The Female Sexual Function Index (FSFI) were used to&#xD;
      assess the sexual function. Patients were monitored for discomfort and side-effects during&#xD;
      treatment and follow up period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2012</start_date>
  <completion_date type="Actual">August 30, 2013</completion_date>
  <primary_completion_date type="Actual">August 30, 2013</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>
    <intervention_model_description>Patients assigned randomly to two groups: laser-treatment group and sham (control) group</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Patients are unaware of the assignment. Both groups were treated according to the IncontiLaseTM clinical treatment protocol for SUI with non-ablative thermal-only Er:YAG laser, except that there was no energy output when treating the sham group.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in ICIQ-UI SF score</measure>
    <time_frame>at 3 months after intervention</time_frame>
    <description>International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in PISQ-12 score</measure>
    <time_frame>at 3 months after intervention</time_frame>
    <description>The Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in FSFI score</measure>
    <time_frame>at 3 months after intervention</time_frame>
    <description>The Female Sexual Function Index, a validated generalized questionnaire utilized to assess sexual function in women in a general population.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in perineometry variable maximal contraction pressure</measure>
    <time_frame>at 3 months after intervention</time_frame>
    <description>Measured with Myomed 632 perineometer with the women in supine position.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in perineometry variable average contraction pressure</measure>
    <time_frame>at 3 months after intervention</time_frame>
    <description>Measured with Myomed 632 perineometer with the women in supine position.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from baseline in perineometry variable mean muscle endurance (stamina)</measure>
    <time_frame>at 3 months after intervention</time_frame>
    <description>Measured with Myomed 632 perineometer with the women in supine position.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Side effects</measure>
    <time_frame>up to 3 months after intervention</time_frame>
    <description>Monitoring for side effects during and after intervention</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>One session of non-ablative Er:YAG laser (2940 nm) treatment of the vaginal wall, introitus and vestibule.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The sham control group was treated with the same procedure but with zero intensity settings - without receiving therapeutic irradiation (placebo).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>laser</intervention_name>
    <arm_group_label>Laser</arm_group_label>
    <other_name>IncontiLaseTM</other_name>
    <other_name>IncontiLase</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>sham control</intervention_name>
    <arm_group_label>Sham control</arm_group_label>
    <other_name>placebo</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of stress urinary incontinence&#xD;
&#xD;
          -  sexually active&#xD;
&#xD;
          -  at least one vaginal delivery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pelvic organ prolapse greater than stage I&#xD;
&#xD;
          -  urgency or mixed UI&#xD;
&#xD;
          -  infection&#xD;
&#xD;
          -  previous gynaecologic surgery or irradiation&#xD;
&#xD;
          -  refuse consent&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 21, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>September 27, 2017</last_update_submitted>
  <last_update_submitted_qc>September 27, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Centre Ljubljana</investigator_affiliation>
    <investigator_full_name>Dr Adolf Lukanovič</investigator_full_name>
    <investigator_title>Medical Director of the Division of Gynecology</investigator_title>
  </responsible_party>
  <keyword>stress urinary incontinence</keyword>
  <keyword>sexual dysfunction</keyword>
  <keyword>laser</keyword>
  <keyword>Er:YAG</keyword>
  <keyword>vaginal laser</keyword>
  <keyword>vaginal tightening</keyword>
  <keyword>non-ablative</keyword>
  <keyword>minimally-invasive</keyword>
  <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>
  </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/NCT03296241
org study id: SUI_ErYAG_Sham
nct id: NCT03296241
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Stress urinary incontinence (SUI) is a common complaint in women after childbirth. The aim of
      this study was to evaluate the efficacy and safety of non-ablative Er:YAG laser therapy in
      the treatment of SUI and improvement of sexual gratification in parous women. 114
      premenopausal parous women with SUI were randomized in two groups of 57 women; a laser
      intervention group and sham control (placebo) group. Both groups were treated according to
      the IncontiLaseTM clinical treatment protocol for SUI with non-ablative thermal-only Er:YAG
      laser, except that there was no energy output when treating the sham group. Patients were
      blinded to the allocation. At baseline and 3 months after treatment patients were clinically
      examined, answered questionnaires for SUI severity sexual function assessment and their
      pelvic floor muscle (PFM) function was assessed with perineometry. The improvement in the
      laser group will be compared to the improvement in the sham group.
Stress urinary incontinence (SUI) is a common complaint in women after childbirth. It affects
      their quality of life and sexual satisfaction and is one of the major reasons for
      gynaecological surgery. There is a need for effective non-invasive treatment alternatives.
      The aim of this study was to evaluate the efficacy and safety of non-ablative Er:YAG laser
      therapy in the treatment of SUI and improvement of sexual gratification in parous women. 114
      premenopausal parous women with SUI were randomized in two groups of 57 women; a laser
      intervention group and sham control (placebo) group. Both groups were treated according to
      the IncontiLaseTM clinical treatment protocol for SUI with non-ablative thermal-only Er:YAG
      laser, except that there was no energy output when treating the sham group. Patients were
      blinded to the allocation. At baseline and 3 months after treatment patients were clinically
      examined, answered questionnaires for SUI severity sexual function assessment and their
      pelvic floor muscle (PFM) function was assessed with perineometry. Validated International
      Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form (ICIQ-UI SF) was
      used as the primary outcome measure. The Pelvic Organ Prolapse Urinary Incontinence Sexual
      Questionnaire short form (PISQ-12) and The Female Sexual Function Index (FSFI) were used to
      assess the sexual function. Patients were monitored for discomfort and side-effects during
      treatment and follow up period.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients assigned randomly to two groups: laser-treatment group and sham (control) group
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Patients are unaware of the assignment. Both groups were treated according to the IncontiLaseTM clinical treatment protocol for SUI with non-ablative thermal-only Er:YAG laser, except that there was no energy output when treating the sham group.
measure: Change from baseline in ICIQ-UI SF score
time frame: at 3 months after intervention
description: International Consultation on Incontinence Questionnaire - Urinary Incontinence Short Form
measure: Change from baseline in PISQ-12 score
time frame: at 3 months after intervention
description: The Pelvic Organ Prolapse Urinary Incontinence Sexual Questionnaire
measure: Change from baseline in FSFI score
time frame: at 3 months after intervention
description: The Female Sexual Function Index, a validated generalized questionnaire utilized to assess sexual function in women in a general population.
measure: Change from baseline in perineometry variable maximal contraction pressure
time frame: at 3 months after intervention
description: Measured with Myomed 632 perineometer with the women in supine position.
measure: Change from baseline in perineometry variable average contraction pressure
time frame: at 3 months after intervention
description: Measured with Myomed 632 perineometer with the women in supine position.
measure: Change from baseline in perineometry variable mean muscle endurance (stamina)
time frame: at 3 months after intervention
description: Measured with Myomed 632 perineometer with the women in supine position.
measure: Side effects
time frame: up to 3 months after intervention
description: Monitoring for side effects during and after intervention
arm group label: Laser
arm group type: Experimental
description: One session of non-ablative Er:YAG laser (2940 nm) treatment of the vaginal wall, introitus and vestibule.
arm group label: Sham control
arm group type: Sham Comparator
description: The sham control group was treated with the same procedure but with zero intensity settings - without receiving therapeutic irradiation (placebo).
intervention type: Device
intervention name: laser
arm group label: Laser
other name: IncontiLaseTM
other name: IncontiLase
intervention type: Device
intervention name: sham control
arm group label: Sham control
other name: placebo
criteria: 
gender: Female
minimum age: 35 Years
maximum age: 65 Years
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: University Medical Centre Ljubljana
investigator full name: Dr Adolf Lukanovič
investigator title: Medical Director of the Division of Gynecology
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
sharing ipd: No