<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/NCT01672190</url>
  </required_header>
  <id_info>
    <org_study_id>12-09389</org_study_id>
    <nct_id>NCT01672190</nct_id>
  </id_info>
  <brief_title>Lessening Incontinence by Learning Yoga</brief_title>
  <acronym>LILY</acronym>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the feasibility of recruiting women with urinary&#xD;
      incontinence into a randomized controlled trial of a yoga therapy program.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks</measure>
    <time_frame>6 weeks</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Urinary Incontinence</condition>
  <condition>Stress Urinary Incontinence</condition>
  <condition>Urge Urinary Incontinence</condition>
  <condition>Over Active Bladder</condition>
  <arm_group>
    <arm_group_label>Yoga Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women in the Yoga Therapy Group will receive twice weekly yoga classes for 6 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Women in the Control Group will wait 6 weeks before receiving a gift certificate for yoga classes at an external yoga studio in the San Francisco Bay Area</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Yoga Therapy Program</intervention_name>
    <arm_group_label>Yoga Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 40 years or older who report urinary incontinence for &gt; 3 months prior to&#xD;
             screening&#xD;
&#xD;
          -  Self-report at least 7 urinary incontinence episodes per week on a screening 7-day&#xD;
             voiding diary&#xD;
&#xD;
          -  Self-report urgency-predominant, stress-predominant, or mixed-type incontinence on the&#xD;
             screening voiding diary&#xD;
&#xD;
          -  Willing to refrain from initiating medical treatments that may affect their&#xD;
             incontinence or voiding pattern during the study period&#xD;
&#xD;
          -  Capable of understanding study procedures and giving informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participation in a yoga class or other formal or organized yoga instruction in the&#xD;
             past year&#xD;
&#xD;
          -  Any prior yoga therapy directed specifically at improving urinary incontinence or&#xD;
             pelvic floor dysfunction&#xD;
&#xD;
          -  Current use of medical therapy or device (i.e. pessary) for incontinence or use within&#xD;
             the previous month&#xD;
&#xD;
          -  Currently pregnant, gave birth within the past 6 months, or planning pregnancy during&#xD;
             the study period&#xD;
&#xD;
          -  Current urinary tract infection or a history or 3 or more urinary tract infections in&#xD;
             the preceding year&#xD;
&#xD;
          -  Report history of neurologic conditions such as stroke, multiple sclerosis, spinal&#xD;
             cord injury, or Parkinson's disease, or a lumbosacral spine condition associated with&#xD;
             neurological symptoms&#xD;
&#xD;
          -  Unable to walk up a flight of stairs or at least 2 blocks on level ground without&#xD;
             assistance&#xD;
&#xD;
          -  Unable to get up from a supine to a standing position in 10 seconds or less and&#xD;
             without assistance&#xD;
&#xD;
          -  Severe obesity, defined as body mass index &gt; 35 kg/m2 on screening examination&#xD;
&#xD;
          -  Report history of interstitial cystitis, fistula or hole in bladder or rectum, or&#xD;
             birth defect leading to urine leakage&#xD;
&#xD;
          -  Report any history of prior anti-incontinence or urethral surgery (not including&#xD;
             urethral dilation), pelvic cancer, or pelvic irradiation for any reason&#xD;
&#xD;
          -  Report use of bladder botox, electrostimulation, bladder training, or pelvic floor&#xD;
             exercise training (with certified practitioners) in the past 3 months&#xD;
&#xD;
          -  Report other surgery to the pelvis (hysterectomy, oophorectomy, vaginal surgery,&#xD;
             bladder surgery, colon surgery) within the past 3 months&#xD;
&#xD;
          -  Report symptomatic pelvic organ prolapse&#xD;
&#xD;
          -  Report history of vulvodynia, chronic pelvic pain, or pain when practicing pelvic&#xD;
             floor exercises&#xD;
&#xD;
          -  Report conditions that, in the judgment of the investigators, render potential&#xD;
             participants unlikely to follow the protocol, including plans to move, substance&#xD;
             abuse, significant psychiatric problems, or dementia&#xD;
&#xD;
          -  Participation in another research study that involves investigational drugs or devices&#xD;
             that could potentially confound the results of this study&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California, San Francisco</name>
      <address>
        <city>San Francisco</city>
        <state>California</state>
        <zip>94115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2013</verification_date>
  <study_first_submitted>August 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 24, 2012</study_first_posted>
  <last_update_submitted>January 16, 2013</last_update_submitted>
  <last_update_submitted_qc>January 16, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 17, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of California, San Francisco</investigator_affiliation>
    <investigator_full_name>Alison Huang</investigator_full_name>
    <investigator_title>Assistant 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>
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
    <mesh_term>Urinary Incontinence, Urge</mesh_term>
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
  </condition_browse>
  <!-- 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/NCT01672190
org study id: 12-09389
nct id: NCT01672190
lead sponsor: 
has dmc: No
The purpose of this study is to assess the feasibility of recruiting women with urinary
      incontinence into a randomized controlled trial of a yoga therapy program.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in the number of incontinence episodes over 7 days, with 95% confidence intervals, between baseline and 6 weeks
time frame: 6 weeks
arm group label: Yoga Therapy
arm group type: Experimental
description: Women in the Yoga Therapy Group will receive twice weekly yoga classes for 6 weeks.
arm group label: Control
arm group type: No Intervention
description: Women in the Control Group will wait 6 weeks before receiving a gift certificate for yoga classes at an external yoga studio in the San Francisco Bay Area
intervention type: Other
intervention name: Yoga Therapy Program
arm group label: Yoga Therapy
criteria: 
gender: Female
minimum age: 40 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of California, San Francisco
investigator full name: Alison Huang
investigator title: Assistant Professor
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
mesh term: Urinary Incontinence, Urge
mesh term: Urinary Bladder, Overactive