<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/NCT03000647</url>
  </required_header>
  <id_info>
    <org_study_id>EC 65-15 HGV</org_study_id>
    <nct_id>NCT03000647</nct_id>
  </id_info>
  <brief_title>Guided Versus Non-guided Pelvic Floor Exercises for Urinary Incontinence in Relapsing-Remitting Multiple Sclerosis</brief_title>
  <official_title>Assessment of the Effectiveness of Guided by a Physiotherapist Versus Non-guided Pelvic Floor Exercises for Urinary Incontinence (UI) in Patients With Relapsing-Remitting (RR) Multiple Sclerosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad Rey Juan Carlos</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study is to evaluate the effectiveness of guided versus non guided pelvic&#xD;
      floor exercises for urinary incontinence in patients with Relapsing-Remitting Multiple&#xD;
      Sclerosis&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Subjects of the study should conduct a specific training in pelvic floor exercises. They were&#xD;
      randomly assigned into 2 groups: Group A only received written instructions for exercises to&#xD;
      be performed at home; Group B received written instructions and, in addition, exercises were&#xD;
      performed in a 30 minutes weekly session with a physiotherapist guiding them&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2015</start_date>
  <completion_date type="Actual">October 2016</completion_date>
  <primary_completion_date type="Actual">October 2016</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>Decrease in the number of urinary leakages from baseline</measure>
    <time_frame>12 weeks</time_frame>
    <description>Difference in the mean number of leakages (Registered for 3 days with a bladder diary)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Decrease of urinary incontinence severity from baseline</measure>
    <time_frame>4,8 and 12 weeks</time_frame>
    <description>Comparison of the results: Questions 1, 2 and 3 of the International Consultation on Incontinence Questionnaire (ICIQ-SF) between the group 1 and 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in quality of life from baseline</measure>
    <time_frame>4,8 and 12 weeks</time_frame>
    <description>Comparison of the results (Question 3 of the questionnaire ICIQ-SF and second part (13 questions) of the Overactive Bladder questionnaire (OABQ-SF) between the group 1 and 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Decrease in the number of urinary leakages from baseline</measure>
    <time_frame>4 and 8 weeks</time_frame>
    <description>Comparison of the results (Registered for 3 days with a bladder diary) between the group 1 and 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lower urinary tract symptoms from baseline</measure>
    <time_frame>4,8 and 12 weeks</time_frame>
    <description>Comparison of de results (First part (6 questions) of the questionnaire OABQ-SF) between the group 1 and 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adherence</measure>
    <time_frame>12 weeks</time_frame>
    <description>Comparison of the results (Registered with exercise diary)between the group 1 and 2</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Relapsing-Remitting Multiple Sclerosis</condition>
  <condition>Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Guided Pelvic floor exercises</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pelvic floor exercises guided by a physiotherapist</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-guided pelvic floor exercises</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Pelvic floor exercises not guided</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Pelvic floor exercises guided by a physiotherapist</intervention_name>
    <description>Subjects perform two types of contractions of the pelvic floor in two different positions 3 times a day and once a week they check it with a physiotherapist (this day only they do it twice at home)</description>
    <arm_group_label>Guided Pelvic floor exercises</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non guided pelvic floor exercises</intervention_name>
    <description>Subjects perform two types of contractions of the pelvic floor in two different positions 3 times a day. They do not attend to meetings with a physiotherapist</description>
    <arm_group_label>Non-guided pelvic floor exercises</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Diagnosed with Relapsing-Remitting Multiple Sclerosis&#xD;
&#xD;
          2. Diagnosed with Urinary Incontinence&#xD;
&#xD;
          3. Minimental Sate Examination (MMSE) scale: More than 24&#xD;
&#xD;
          4. Expanded Disability Status Scale (EDSS) scale: Bladder function 0-4; EDSS 0-6,5&#xD;
&#xD;
          5. Willing to participate in the study&#xD;
&#xD;
          6. Having Signed an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Diagnosed with another neurological disease&#xD;
&#xD;
          2. Diagnosed with kidney diseases&#xD;
&#xD;
          3. Having a Relapse of the disease in the last 6 months&#xD;
&#xD;
          4. In Women: Pregnancy os postpartum &lt; 6 months&#xD;
&#xD;
          5. Having gone through surgery for urinary incontinence or prolapses or prostate diseases&#xD;
&#xD;
          6. Having gone through other treatment for pelvic floor&#xD;
&#xD;
          7. MMSE scale: Under 24&#xD;
&#xD;
          8. EDSS scale: Bladder function 5-6 or not knowing; EDSS 7-10&#xD;
&#xD;
          9. ICIQ-SF scale: Severity 19-21&#xD;
&#xD;
         10. Not willing to participate or sign the informed consent form or not able to understand&#xD;
             the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Denise Cuevas, BSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidad Rey Juan Carlos</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital General de Villalba</name>
      <address>
        <city>Villalba</city>
        <state>Madrid</state>
        <zip>28400</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <reference>
    <citation>Quarto G, Autorino R, Gallo A, De Sio M, D'Armiento M, Perdona S, Damiano R. Quality of life in women with multiple sclerosis and overactive bladder syndrome. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Feb;18(2):189-94. doi: 10.1007/s00192-006-0131-9. Epub 2006 May 13.</citation>
    <PMID>16699915</PMID>
  </reference>
  <reference>
    <citation>Gilpin SA, Gilpin CJ, Dixon JS, Gosling JA, Kirby RS. The effect of age on the autonomic innervation of the urinary bladder. Br J Urol. 1986 Aug;58(4):378-81. doi: 10.1111/j.1464-410x.1986.tb09089.x.</citation>
    <PMID>3756405</PMID>
  </reference>
  <reference>
    <citation>Lucio AC, Campos RM, Perissinotto MC, Miyaoka R, Damasceno BP, D'ancona CA. Pelvic floor muscle training in the treatment of lower urinary tract dysfunction in women with multiple sclerosis. Neurourol Urodyn. 2010 Nov;29(8):1410-3. doi: 10.1002/nau.20941.</citation>
    <PMID>20976816</PMID>
  </reference>
  <reference>
    <citation>De Ridder D, Vermeulen C, Ketelaer P, Van Poppel H, Baert L. Pelvic floor rehabilitation in multiple sclerosis. Acta Neurol Belg. 1999 Mar;99(1):61-4.</citation>
    <PMID>10218095</PMID>
  </reference>
  <reference>
    <citation>Litwiller SE, Frohman EM, Zimmern PE. Multiple sclerosis and the urologist. J Urol. 1999 Mar;161(3):743-57. Erratum In: J Urol 1999 Jul;162(1):172.</citation>
    <PMID>10022678</PMID>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>December 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 19, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>July 9, 2019</last_update_submitted>
  <last_update_submitted_qc>July 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">July 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pelvic floor muscle exercise</keyword>
  <keyword>Supervision</keyword>
  <keyword>Physiotherapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Sclerosis</mesh_term>
    <mesh_term>Multiple Sclerosis, Relapsing-Remitting</mesh_term>
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Sclerosis</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/NCT03000647
org study id: EC 65-15 HGV
nct id: NCT03000647
lead sponsor: 
collaborator: 
has dmc: No
The aim of the study is to evaluate the effectiveness of guided versus non guided pelvic
      floor exercises for urinary incontinence in patients with Relapsing-Remitting Multiple
      Sclerosis
Subjects of the study should conduct a specific training in pelvic floor exercises. They were
      randomly assigned into 2 groups: Group A only received written instructions for exercises to
      be performed at home; Group B received written instructions and, in addition, exercises were
      performed in a 30 minutes weekly session with a physiotherapist guiding them
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Decrease in the number of urinary leakages from baseline
time frame: 12 weeks
description: Difference in the mean number of leakages (Registered for 3 days with a bladder diary)
measure: Decrease of urinary incontinence severity from baseline
time frame: 4,8 and 12 weeks
description: Comparison of the results: Questions 1, 2 and 3 of the International Consultation on Incontinence Questionnaire (ICIQ-SF) between the group 1 and 2
measure: Change in quality of life from baseline
time frame: 4,8 and 12 weeks
description: Comparison of the results (Question 3 of the questionnaire ICIQ-SF and second part (13 questions) of the Overactive Bladder questionnaire (OABQ-SF) between the group 1 and 2
measure: Decrease in the number of urinary leakages from baseline
time frame: 4 and 8 weeks
description: Comparison of the results (Registered for 3 days with a bladder diary) between the group 1 and 2
measure: Lower urinary tract symptoms from baseline
time frame: 4,8 and 12 weeks
description: Comparison of de results (First part (6 questions) of the questionnaire OABQ-SF) between the group 1 and 2
measure: Adherence
time frame: 12 weeks
description: Comparison of the results (Registered with exercise diary)between the group 1 and 2
arm group label: Guided Pelvic floor exercises
arm group type: Active Comparator
description: Pelvic floor exercises guided by a physiotherapist
arm group label: Non-guided pelvic floor exercises
arm group type: Active Comparator
description: Pelvic floor exercises not guided
intervention type: Procedure
intervention name: Pelvic floor exercises guided by a physiotherapist
description: Subjects perform two types of contractions of the pelvic floor in two different positions 3 times a day and once a week they check it with a physiotherapist (this day only they do it twice at home)
arm group label: Guided Pelvic floor exercises
intervention type: Procedure
intervention name: Non guided pelvic floor exercises
description: Subjects perform two types of contractions of the pelvic floor in two different positions 3 times a day. They do not attend to meetings with a physiotherapist
arm group label: Non-guided pelvic floor exercises
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: No
last name: Denise Cuevas, BSc
role: Principal Investigator
affiliation: Universidad Rey Juan Carlos
facility: 
country: Spain
citation: Quarto G, Autorino R, Gallo A, De Sio M, D'Armiento M, Perdona S, Damiano R. Quality of life in women with multiple sclerosis and overactive bladder syndrome. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Feb;18(2):189-94. doi: 10.1007/s00192-006-0131-9. Epub 2006 May 13.
PMID: 16699915
citation: Gilpin SA, Gilpin CJ, Dixon JS, Gosling JA, Kirby RS. The effect of age on the autonomic innervation of the urinary bladder. Br J Urol. 1986 Aug;58(4):378-81. doi: 10.1111/j.1464-410x.1986.tb09089.x.
PMID: 3756405
citation: Lucio AC, Campos RM, Perissinotto MC, Miyaoka R, Damasceno BP, D'ancona CA. Pelvic floor muscle training in the treatment of lower urinary tract dysfunction in women with multiple sclerosis. Neurourol Urodyn. 2010 Nov;29(8):1410-3. doi: 10.1002/nau.20941.
PMID: 20976816
citation: De Ridder D, Vermeulen C, Ketelaer P, Van Poppel H, Baert L. Pelvic floor rehabilitation in multiple sclerosis. Acta Neurol Belg. 1999 Mar;99(1):61-4.
PMID: 10218095
citation: Litwiller SE, Frohman EM, Zimmern PE. Multiple sclerosis and the urologist. J Urol. 1999 Mar;161(3):743-57. Erratum In: J Urol 1999 Jul;162(1):172.
PMID: 10022678
responsible party type: Sponsor
mesh term: Multiple Sclerosis
mesh term: Multiple Sclerosis, Relapsing-Remitting
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Sclerosis
sharing ipd: No