<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/NCT03273309</url>
  </required_header>
  <id_info>
    <org_study_id>16-0064</org_study_id>
    <nct_id>NCT03273309</nct_id>
  </id_info>
  <brief_title>Comparison of Vibratory Perineal Stimulus With Transvaginal Electrical Stimulation</brief_title>
  <official_title>Comparison of Vibratory Perineal Stimulus With Transvaginal Electrical Stimulation in Women With Urinary Incontinence: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospital de Clinicas de Porto Alegre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospital de Clinicas de Porto Alegre</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>
      Aim: To compare the effects of Vibratory Perineal Stimulus with transvaginal electrical&#xD;
      stimulation to the pelvic floor muscles functionality in women with urinary incontinence and&#xD;
      who are unable to voluntarily contract their pelvic floor muscles.&#xD;
&#xD;
      Study Design: Randomized controlled trial&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  The purpose of this study is to find out the effect of vibratory perineal stimulus&#xD;
           compared to transvaginal electrical stimulation on the functionality of pelvic floor&#xD;
           muscles in women with urinary incontinence who are unable to perform voluntary&#xD;
           contraction of this musculature.&#xD;
&#xD;
        -  Study Design: Randomized controlled trial&#xD;
&#xD;
        -  Search location: The data will collected at the Ambulatory of Urogynecology and&#xD;
           Obstetrics of Porto Alegre Clinical Hospital (HCPA), where the activities of Pelvic&#xD;
           Physiotherapy are performed.and in the Clinical Research Center of the same hospital.&#xD;
&#xD;
        -  Inclusion criteria: women with urinary incontinence with zero or one strength degree of&#xD;
           pelvic floor muscle contraction by the Modified Oxford Scale.&#xD;
&#xD;
        -  Main outcome: Improvement the functionality of pelvic floor muscles&#xD;
&#xD;
        -  Secondary outcome: Improvement of urinary loss&#xD;
&#xD;
        -  First protocol: patients will be referred by the medical team and will undergo&#xD;
           physiotherapeutic evaluation to collect personal data, check the symptoms of urinary&#xD;
           incontinence, apply a quality of life questionnaire and measure pelvic floor muscles&#xD;
           strength. If patient has zero or one degree of pelvic floor muscle strength, will be&#xD;
           referred to the second phase.&#xD;
&#xD;
        -  Second protocol: Patients will be randomized into two groups - Vibratory stimulus group&#xD;
           or electrical stimulation group. Both will follow a 6-week treatment protocol with&#xD;
           intervention once a week. Both are intravaginal devices applied for 20 minutes, with on&#xD;
           cycle of 8 seconds and off cycle of 16 seconds.&#xD;
&#xD;
        -  Final protocol: patients will repeat the initial evaluation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 1, 2017</start_date>
  <completion_date type="Actual">November 15, 2017</completion_date>
  <primary_completion_date type="Actual">November 15, 2017</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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvement in pelvic floor muscles functionality</measure>
    <time_frame>six weeks</time_frame>
    <description>Will be assessed by the PERFECT scheme. Each letter that compose the word means a condition to be evaluated: P = power, E = endurance, R = repetitions, F = fast contractions, E = elevation, C=co-contraction, T= cough reflex.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvement of urinary Incontinence</measure>
    <time_frame>six weeks</time_frame>
    <description>ICIQ-SF - &quot;International Consultation on Incontinence Questionnaire - Short Form&quot;. This questionnaire assesses the type of urinary loss, intensity and impact on quality of life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">42</enrollment>
  <condition>Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Vibratory Perineal Stimulus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>It's thought that the vibratory perineal stimulation can produces afferent nerve impulses that goes to the sacral spinal cord (S2-S4) via the pudendal nerve and stimulates the sacral somatic response which will cause the pelvic muscle contraction.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Transvaginal Electrical Stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Transvaginal electrical stimulation can produces direct and reflex responses of the pelvic floor muscles, being more effective in patients who can't voluntarily contract this musculature. In addition, it increases blood flow to the muscles, restores neuromuscular connections and improves muscle fiber function.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Vibratory Perineal Stimulus</intervention_name>
    <description>Vibratory perineal stimulus will be applied in patients randomized to this group through an intravaginal probe which emits vibratory pulses, with the device fixed in the following parameters:on time = 8 seconds, off time = 16 seconds, total time = 20 minutes. The intervention time will be 6 weeks, with sessions held once a week.</description>
    <arm_group_label>Vibratory Perineal Stimulus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Transvaginal Electrical Stimulation</intervention_name>
    <description>The transvaginal electrical stimulation will be applied in patients randomized to this group through an intravaginal probe which emits electrical pulses, with the device fixed in the following parameters: frequency = 50 Hz, pulse width = 300ms,on time = 8 seconds, off time = 16 seconds, total time = 20 minutes. The intervention time will be 6 weeks, with sessions held once a week.</description>
    <arm_group_label>Transvaginal Electrical Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of urinary incontinence;&#xD;
&#xD;
          -  To be unable to perform a voluntarily contraction of pelvic floor muscles;&#xD;
&#xD;
          -  Understand the instruments used in the research;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Allergy to latex;&#xD;
&#xD;
          -  Individual or group pelvic floor muscle training in the last 6 months.&#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>José Geraldo F Lopes Ramos</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital de Clínicas de Porto Alegre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital de Clínicas de Porto Alegre</name>
      <address>
        <city>Porto Alegre</city>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 26, 2017</study_first_submitted>
  <study_first_submitted_qc>September 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>March 9, 2018</last_update_submitted>
  <last_update_submitted_qc>March 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 12, 2018</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</mesh_term>
    <mesh_term>Enuresis</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/NCT03273309
org study id: 16-0064
nct id: NCT03273309
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim: To compare the effects of Vibratory Perineal Stimulus with transvaginal electrical
      stimulation to the pelvic floor muscles functionality in women with urinary incontinence and
      who are unable to voluntarily contract their pelvic floor muscles.

      Study Design: Randomized controlled trial
-  The purpose of this study is to find out the effect of vibratory perineal stimulus
           compared to transvaginal electrical stimulation on the functionality of pelvic floor
           muscles in women with urinary incontinence who are unable to perform voluntary
           contraction of this musculature.

        -  Study Design: Randomized controlled trial

        -  Search location: The data will collected at the Ambulatory of Urogynecology and
           Obstetrics of Porto Alegre Clinical Hospital (HCPA), where the activities of Pelvic
           Physiotherapy are performed.and in the Clinical Research Center of the same hospital.

        -  Inclusion criteria: women with urinary incontinence with zero or one strength degree of
           pelvic floor muscle contraction by the Modified Oxford Scale.

        -  Main outcome: Improvement the functionality of pelvic floor muscles

        -  Secondary outcome: Improvement of urinary loss

        -  First protocol: patients will be referred by the medical team and will undergo
           physiotherapeutic evaluation to collect personal data, check the symptoms of urinary
           incontinence, apply a quality of life questionnaire and measure pelvic floor muscles
           strength. If patient has zero or one degree of pelvic floor muscle strength, will be
           referred to the second phase.

        -  Second protocol: Patients will be randomized into two groups - Vibratory stimulus group
           or electrical stimulation group. Both will follow a 6-week treatment protocol with
           intervention once a week. Both are intravaginal devices applied for 20 minutes, with on
           cycle of 8 seconds and off cycle of 16 seconds.

        -  Final protocol: patients will repeat the initial evaluation.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Improvement in pelvic floor muscles functionality
time frame: six weeks
description: Will be assessed by the PERFECT scheme. Each letter that compose the word means a condition to be evaluated: P = power, E = endurance, R = repetitions, F = fast contractions, E = elevation, C=co-contraction, T= cough reflex.
measure: Improvement of urinary Incontinence
time frame: six weeks
description: ICIQ-SF - "International Consultation on Incontinence Questionnaire - Short Form". This questionnaire assesses the type of urinary loss, intensity and impact on quality of life.
arm group label: Vibratory Perineal Stimulus
arm group type: Active Comparator
description: It's thought that the vibratory perineal stimulation can produces afferent nerve impulses that goes to the sacral spinal cord (S2-S4) via the pudendal nerve and stimulates the sacral somatic response which will cause the pelvic muscle contraction.
arm group label: Transvaginal Electrical Stimulation
arm group type: Active Comparator
description: Transvaginal electrical stimulation can produces direct and reflex responses of the pelvic floor muscles, being more effective in patients who can't voluntarily contract this musculature. In addition, it increases blood flow to the muscles, restores neuromuscular connections and improves muscle fiber function.
intervention type: Other
intervention name: Vibratory Perineal Stimulus
description: Vibratory perineal stimulus will be applied in patients randomized to this group through an intravaginal probe which emits vibratory pulses, with the device fixed in the following parameters:on time = 8 seconds, off time = 16 seconds, total time = 20 minutes. The intervention time will be 6 weeks, with sessions held once a week.
arm group label: Vibratory Perineal Stimulus
intervention type: Other
intervention name: Transvaginal Electrical Stimulation
description: The transvaginal electrical stimulation will be applied in patients randomized to this group through an intravaginal probe which emits electrical pulses, with the device fixed in the following parameters: frequency = 50 Hz, pulse width = 300ms,on time = 8 seconds, off time = 16 seconds, total time = 20 minutes. The intervention time will be 6 weeks, with sessions held once a week.
arm group label: Transvaginal Electrical Stimulation
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: José Geraldo F Lopes Ramos
role: Principal Investigator
affiliation: Hospital de Clínicas de Porto Alegre
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
sharing ipd: Undecided