<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/NCT03265509</url>
  </required_header>
  <id_info>
    <org_study_id>2014/1203</org_study_id>
    <nct_id>NCT03265509</nct_id>
  </id_info>
  <brief_title>Effect of Glutamine on Urinary Incontinence</brief_title>
  <official_title>Assessment of the Effect of Glutamine Supplementation in Addition to Exercise on Pelvic Floor Muscle Strength and Clinical Parameters in Women With Urinary Incontinence or Pelvic Organ Prolapse</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Société des Produits Nestlé (SPN)</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Istanbul University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to determine to effect of additional oral glutamine to Kegel&#xD;
      exercises on pelvic floor strength and clinical parameters of urinary incontinence in females&#xD;
      with either urinary incontinence (stress and/or urgency) and pelvic prolapse.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Urinary incontinence is a prevalent and costly condition that affects approximately 38% of&#xD;
      older community-dwelling women (age&gt;60 years). Incontinence predisposes patients to other&#xD;
      health problems, contributes to depression and social isolation, is a significant source of&#xD;
      dependency among the elderly, and is widely cited as a factor in nursing home admissions.&#xD;
      Sarcopenia is age-related and is characterized by loss of muscle mass, strength and&#xD;
      endurance. There is not only a decrease in the number of muscle fibers, but also atrophy in&#xD;
      the remaining ones. Several studies indicate glutamine supplementations lead to better muscle&#xD;
      performance by stimulate muscle producing in extremities. Similarly, we assume glutamine&#xD;
      supplementation could increase pelvic muscle mass and improve the pelvic floor strength. From&#xD;
      this point, using glutamine supplementation may effect positively on stress, urge or mixed&#xD;
      incontinence, and pelvic prolapse.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2016</start_date>
  <completion_date type="Actual">September 2018</completion_date>
  <primary_completion_date type="Actual">September 2018</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pelvic floor muscle strength with dynamometer</measure>
    <time_frame>3 months</time_frame>
    <description>vaginal dynamometer</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pelvic floor muscle strength with digital palpation</measure>
    <time_frame>3 months</time_frame>
    <description>digital vaginal palpation method</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>body composition</measure>
    <time_frame>3 months</time_frame>
    <description>muscle mass assessed by bioimpedance analysis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>quality of life related prolapse</measure>
    <time_frame>3 months</time_frame>
    <description>Prolapse quality of life (PQOL) questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>general quality of life</measure>
    <time_frame>3 months</time_frame>
    <description>King's Health Questionnaire (KHQ)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>24 hour pad test</measure>
    <time_frame>3 months</time_frame>
    <description>assessment of the severity of urinary incontinence as determined by the 24-hour pad weight</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>hand grip strength</measure>
    <time_frame>3 months</time_frame>
    <description>Jamar hand dynamometer</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>urinary incontinence dairy</measure>
    <time_frame>3 months</time_frame>
    <description>urinary incontinence dairy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>degree of prolapse</measure>
    <time_frame>3 months</time_frame>
    <description>systematic pelvic examination</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Glutamine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>30 g/day Glutamine supplementation for three months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Fantomalt</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>30 g/day Fantomalt supplementation for three months</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>glutamine supplementation</intervention_name>
    <description>30 g/day glutamine supplementation for three months</description>
    <arm_group_label>Glutamine</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>fantomalt supplementation</intervention_name>
    <description>30 g/day fantomalt supplementation for three months</description>
    <arm_group_label>Fantomalt</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of urinary incontinence and/or pelvic prolapse and/or decreased vaginal&#xD;
             muscle strength in gynaecological examination&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Uncontrolled diabetes&#xD;
&#xD;
          -  Cognitive dysfunction hampering participation in exercise or assessment&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gulistan Bahat Ozturk, Ass. Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istanbul University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul University Istanbul Faculty of Medicine</name>
      <address>
        <city>Istanbul</city>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 26, 2017</study_first_submitted>
  <study_first_submitted_qc>August 26, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>August 6, 2019</last_update_submitted>
  <last_update_submitted_qc>August 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul University</investigator_affiliation>
    <investigator_full_name>Gulistan Bahat-Ozturk</investigator_full_name>
    <investigator_title>Associate Professor</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>
  </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/NCT03265509
org study id: 2014/1203
nct id: NCT03265509
lead sponsor: 
collaborator: 
has dmc: No
The objective of this study is to determine to effect of additional oral glutamine to Kegel
      exercises on pelvic floor strength and clinical parameters of urinary incontinence in females
      with either urinary incontinence (stress and/or urgency) and pelvic prolapse.
Urinary incontinence is a prevalent and costly condition that affects approximately 38% of
      older community-dwelling women (age>60 years). Incontinence predisposes patients to other
      health problems, contributes to depression and social isolation, is a significant source of
      dependency among the elderly, and is widely cited as a factor in nursing home admissions.
      Sarcopenia is age-related and is characterized by loss of muscle mass, strength and
      endurance. There is not only a decrease in the number of muscle fibers, but also atrophy in
      the remaining ones. Several studies indicate glutamine supplementations lead to better muscle
      performance by stimulate muscle producing in extremities. Similarly, we assume glutamine
      supplementation could increase pelvic muscle mass and improve the pelvic floor strength. From
      this point, using glutamine supplementation may effect positively on stress, urge or mixed
      incontinence, and pelvic prolapse.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Pelvic floor muscle strength with dynamometer
time frame: 3 months
description: vaginal dynamometer
measure: Pelvic floor muscle strength with digital palpation
time frame: 3 months
description: digital vaginal palpation method
measure: body composition
time frame: 3 months
description: muscle mass assessed by bioimpedance analysis
measure: quality of life related prolapse
time frame: 3 months
description: Prolapse quality of life (PQOL) questionnaire
measure: general quality of life
time frame: 3 months
description: King's Health Questionnaire (KHQ)
measure: 24 hour pad test
time frame: 3 months
description: assessment of the severity of urinary incontinence as determined by the 24-hour pad weight
measure: hand grip strength
time frame: 3 months
description: Jamar hand dynamometer
measure: urinary incontinence dairy
time frame: 3 months
description: urinary incontinence dairy
measure: degree of prolapse
time frame: 3 months
description: systematic pelvic examination
arm group label: Glutamine
arm group type: Active Comparator
description: 30 g/day Glutamine supplementation for three months
arm group label: Fantomalt
arm group type: Placebo Comparator
description: 30 g/day Fantomalt supplementation for three months
intervention type: Dietary Supplement
intervention name: glutamine supplementation
description: 30 g/day glutamine supplementation for three months
arm group label: Glutamine
intervention type: Dietary Supplement
intervention name: fantomalt supplementation
description: 30 g/day fantomalt supplementation for three months
arm group label: Fantomalt
criteria: 
gender: Female
minimum age: 45 Years
maximum age: 100 Years
healthy volunteers: No
last name: Gulistan Bahat Ozturk, Ass. Prof.
role: Principal Investigator
affiliation: Istanbul University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Istanbul University
investigator full name: Gulistan Bahat-Ozturk
investigator title: Associate Professor
mesh term: Urinary Incontinence
mesh term: Enuresis
sharing ipd: No