<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/NCT04428853</url>
  </required_header>
  <id_info>
    <org_study_id>SadiaS</org_study_id>
    <nct_id>NCT04428853</nct_id>
  </id_info>
  <brief_title>Effects of Iyengar Yoga Therapy in the Management of Stress Urinary Incontinence Among Young Females</brief_title>
  <official_title>Effects of Iyengar Yoga Therapy in the Management of Stress Urinary Incontinence Among</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ziauddin University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ziauddin University</source>
  <oversight_info>
    <has_dmc>Yes</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 study is aimed to identify the feasibility, safety, and efficacy of iyengar Yoga therapy&#xD;
      in the management of stress urinary incontinence among young female&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 44 young female participants will be recruited in this study after signing a&#xD;
      written consent. Participants will be attending a 1 hour orientation session prior to yoga&#xD;
      therapy providing a general introduction that includes principles, effectiveness and use of&#xD;
      props in Iyengar yoga. A schedule will be design by the researcher for group yoga therapy of&#xD;
      the participant twice a week, each session lasting for 75- minutes for the duration of 8&#xD;
      weeks by a certified yoga instructor and an assistant. Participants will also instruct to&#xD;
      practice yoga at home for 1 additional day per week and to record the dates and duration of&#xD;
      practice at home. A manual will be given to the participants with written descriptions in&#xD;
      both English and Urdu with pictures portraying each of the key yoga postures performed in the&#xD;
      classes. Tips on how to practice each posture safely and comfortably and how to adapt each&#xD;
      posture to improve incontinence and pelvic floor function will also be provided in the&#xD;
      manual.&#xD;
&#xD;
      Protocols for Yoga Group:&#xD;
&#xD;
      The protocols for Iyengar yoga Therapy will be based on 2 days supervised group yoga classes&#xD;
      with an additional 1 day of home yoga performed per week for 8-weeks. Each session will be&#xD;
      performed for 75 minutes. This protocol will include 5 phases 1) warm up 2) Pranayamas 3)&#xD;
      Active Phase 4) Restorative Phase 5) Meditation.&#xD;
&#xD;
      Warm up:&#xD;
&#xD;
      Warm up will be performed with slow movement combined with breathing for 10 minutes in order&#xD;
      to increase core body temperature, lubrication of joint, make connection of mind body spirit&#xD;
      and improve blood circulation. Four different postures that will be performed by the&#xD;
      participants under the supervision of certified yoga therapist includes cat/cow, wag the&#xD;
      tail, thoracic rotation and rock backs. Each posture will be repeated with 5-10 breaths&#xD;
      (Miller, 2017).&#xD;
&#xD;
      Pranayamas:&#xD;
&#xD;
      This phase will be consisted of 2 kinds of breathing patterns including Bhramari breathing.&#xD;
      This will be performed 5 times with the hold of 10 seconds and Nadi Shodhana breathing. This&#xD;
      will be repeated 10 times with the hold of 10 seconds.&#xD;
&#xD;
      Active Phase:&#xD;
&#xD;
      Active phase will be focused on 12 Asanas that are performed in Standing, Sitting and supine&#xD;
      positions, directly addressing pelvic floor muscles. In standing postures, Trikonasana,&#xD;
      Parsvokonasana, Tadasana, Parsvottasana, Virabhadrasana II, Utkatasana whereas, In Sitting&#xD;
      postures, Bharadvajasana, Malasana, Baddha Konasana, and In Supine postures participants will&#xD;
      instruct to perform Supta Padagushthasana, Supta Baddha Konasana, Salamba Set Bandhasana.&#xD;
&#xD;
      All of the Asanas will be performed with 5 repetitions. Participants will be maintaining each&#xD;
      position for the duration of 15 seconds whereas; intermittent rest of 30 seconds will be&#xD;
      given between each yoga posture.&#xD;
&#xD;
      Restorative Phase:&#xD;
&#xD;
      This phase will be focused on postures that rejuvenate the body, mind and spirit while&#xD;
      reducing stress and tension of the body. It consists of two postures Viparita Karani&#xD;
      Variation and Savasana. Participants must stay in each posture for 4-5 minutes. Meditation:&#xD;
&#xD;
      Meditation guided by breath and mind awareness of the whole body for 10 minutes with calm&#xD;
      music.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 15, 2020</start_date>
  <completion_date type="Actual">June 30, 2021</completion_date>
  <primary_completion_date type="Actual">March 15, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pelvic muscle strength (Pre treatment)</measure>
    <time_frame>baseline</time_frame>
    <description>Perineometer is used to to assess pelvic muscle strength</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pelvic muscle strength (Post treatment)</measure>
    <time_frame>4th week after intervention</time_frame>
    <description>Perineometer is used to to assess pelvic muscle strength</description>
  </primary_outcome>
  <primary_outcome>
    <measure>pelvic muscle strength (Post treatment)</measure>
    <time_frame>8th week after intervention</time_frame>
    <description>Perineometer is used to to assess pelvic muscle strength</description>
  </primary_outcome>
  <primary_outcome>
    <measure>quantity of urine leakage (Pre treatment)</measure>
    <time_frame>baseline</time_frame>
    <description>1-hour pad test is used to measure the quantity of urine leakage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>quantity of urine leakage (Post treatment)</measure>
    <time_frame>4th week after intervention</time_frame>
    <description>1-hour pad test is used to measure the quantity of urine leakage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>quantity of urine leakage (Post treatment)</measure>
    <time_frame>8th week after intervention</time_frame>
    <description>1-hour pad test is used to measure the quantity of urine leakage</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life (Pre treatment)</measure>
    <time_frame>baseline</time_frame>
    <description>International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is used to assess the quality of life. The total score ranges from 0 to 21, interpretation include; 1 to 5 = Mild, 6 to 12 = moderate, 13 to 18 = severe, 19 to 21 = very severe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life (Post treatment)</measure>
    <time_frame>4th week after intervention</time_frame>
    <description>International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is used to assess the quality of life. The total score ranges from 0 to 21, interpretation include; 1 to 5 = Mild, 6 to 12 = moderate, 13 to 18 = severe, 19 to 21 = very severe</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Quality of life (Post treatment)</measure>
    <time_frame>8th week after intervention</time_frame>
    <description>International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is used to assess the quality of life. The total score ranges from 0 to 21, interpretation include; 1 to 5 = Mild, 6 to 12 = moderate, 13 to 18 = severe, 19 to 21 = very severe</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">44</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A schedule has designed by the researcher for group yoga therapy of the participant twice a week, each session lasting for 75- minutes for the duration of 8 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>iyengar yoga</intervention_name>
    <description>different yoga postures including warm up, cool down and meditation that incorporate 75 minutes of training</description>
    <arm_group_label>exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Married Females of age 17-40 year&#xD;
&#xD;
          -  Diagnosed Cases of Stress Urinary Incontinence due to pelvic floor muscle weakness&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Current Urinary Tract Infection (UTI) or hematuria&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  On pharmacological treatment of SUI&#xD;
&#xD;
          -  Any red flags&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>17 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>sadia shafaq</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ziauddin University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ziauddin university</name>
      <address>
        <city>Karachi</city>
        <state>Sindh</state>
        <zip>74000</zip>
        <country>Pakistan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Pakistan</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>April 12, 2022</last_update_submitted>
  <last_update_submitted_qc>April 12, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2022</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>
    <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/NCT04428853
org study id: SadiaS
nct id: NCT04428853
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
the study is aimed to identify the feasibility, safety, and efficacy of iyengar Yoga therapy
      in the management of stress urinary incontinence among young female
A total of 44 young female participants will be recruited in this study after signing a
      written consent. Participants will be attending a 1 hour orientation session prior to yoga
      therapy providing a general introduction that includes principles, effectiveness and use of
      props in Iyengar yoga. A schedule will be design by the researcher for group yoga therapy of
      the participant twice a week, each session lasting for 75- minutes for the duration of 8
      weeks by a certified yoga instructor and an assistant. Participants will also instruct to
      practice yoga at home for 1 additional day per week and to record the dates and duration of
      practice at home. A manual will be given to the participants with written descriptions in
      both English and Urdu with pictures portraying each of the key yoga postures performed in the
      classes. Tips on how to practice each posture safely and comfortably and how to adapt each
      posture to improve incontinence and pelvic floor function will also be provided in the
      manual.

      Protocols for Yoga Group:

      The protocols for Iyengar yoga Therapy will be based on 2 days supervised group yoga classes
      with an additional 1 day of home yoga performed per week for 8-weeks. Each session will be
      performed for 75 minutes. This protocol will include 5 phases 1) warm up 2) Pranayamas 3)
      Active Phase 4) Restorative Phase 5) Meditation.

      Warm up:

      Warm up will be performed with slow movement combined with breathing for 10 minutes in order
      to increase core body temperature, lubrication of joint, make connection of mind body spirit
      and improve blood circulation. Four different postures that will be performed by the
      participants under the supervision of certified yoga therapist includes cat/cow, wag the
      tail, thoracic rotation and rock backs. Each posture will be repeated with 5-10 breaths
      (Miller, 2017).

      Pranayamas:

      This phase will be consisted of 2 kinds of breathing patterns including Bhramari breathing.
      This will be performed 5 times with the hold of 10 seconds and Nadi Shodhana breathing. This
      will be repeated 10 times with the hold of 10 seconds.

      Active Phase:

      Active phase will be focused on 12 Asanas that are performed in Standing, Sitting and supine
      positions, directly addressing pelvic floor muscles. In standing postures, Trikonasana,
      Parsvokonasana, Tadasana, Parsvottasana, Virabhadrasana II, Utkatasana whereas, In Sitting
      postures, Bharadvajasana, Malasana, Baddha Konasana, and In Supine postures participants will
      instruct to perform Supta Padagushthasana, Supta Baddha Konasana, Salamba Set Bandhasana.

      All of the Asanas will be performed with 5 repetitions. Participants will be maintaining each
      position for the duration of 15 seconds whereas; intermittent rest of 30 seconds will be
      given between each yoga posture.

      Restorative Phase:

      This phase will be focused on postures that rejuvenate the body, mind and spirit while
      reducing stress and tension of the body. It consists of two postures Viparita Karani
      Variation and Savasana. Participants must stay in each posture for 4-5 minutes. Meditation:

      Meditation guided by breath and mind awareness of the whole body for 10 minutes with calm
      music.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: pelvic muscle strength (Pre treatment)
time frame: baseline
description: Perineometer is used to to assess pelvic muscle strength
measure: pelvic muscle strength (Post treatment)
time frame: 4th week after intervention
description: Perineometer is used to to assess pelvic muscle strength
measure: pelvic muscle strength (Post treatment)
time frame: 8th week after intervention
description: Perineometer is used to to assess pelvic muscle strength
measure: quantity of urine leakage (Pre treatment)
time frame: baseline
description: 1-hour pad test is used to measure the quantity of urine leakage
measure: quantity of urine leakage (Post treatment)
time frame: 4th week after intervention
description: 1-hour pad test is used to measure the quantity of urine leakage
measure: quantity of urine leakage (Post treatment)
time frame: 8th week after intervention
description: 1-hour pad test is used to measure the quantity of urine leakage
measure: Quality of life (Pre treatment)
time frame: baseline
description: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is used to assess the quality of life. The total score ranges from 0 to 21, interpretation include; 1 to 5 = Mild, 6 to 12 = moderate, 13 to 18 = severe, 19 to 21 = very severe
measure: Quality of life (Post treatment)
time frame: 4th week after intervention
description: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is used to assess the quality of life. The total score ranges from 0 to 21, interpretation include; 1 to 5 = Mild, 6 to 12 = moderate, 13 to 18 = severe, 19 to 21 = very severe
measure: Quality of life (Post treatment)
time frame: 8th week after intervention
description: International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) is used to assess the quality of life. The total score ranges from 0 to 21, interpretation include; 1 to 5 = Mild, 6 to 12 = moderate, 13 to 18 = severe, 19 to 21 = very severe
arm group label: exercise
arm group type: Experimental
description: A schedule has designed by the researcher for group yoga therapy of the participant twice a week, each session lasting for 75- minutes for the duration of 8 weeks
intervention type: Behavioral
intervention name: iyengar yoga
description: different yoga postures including warm up, cool down and meditation that incorporate 75 minutes of training
arm group label: exercise
criteria: 
gender: Female
gender based: Yes
minimum age: 17 Years
maximum age: 40 Years
healthy volunteers: Accepts Healthy Volunteers
last name: sadia shafaq
role: Principal Investigator
affiliation: Ziauddin University
facility: 
country: Pakistan
responsible party type: Sponsor
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
sharing ipd: No