<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/NCT02261740</url>
  </required_header>
  <id_info>
    <org_study_id>14-13946</org_study_id>
    <nct_id>NCT02261740</nct_id>
  </id_info>
  <brief_title>Program to Overcome Pelvic Pain With Yoga</brief_title>
  <acronym>POPPY</acronym>
  <official_title>Program to Overcome Pelvic Pain With Yoga (POPPY) (a.k.a., Development of a Therapeutic Yoga Program for Female Genito-Pelvic Pain)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, San Francisco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Patty Brisben Foundation For Women's Sexual Health</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, San Francisco</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The POPPY Study is a pilot of an Iyengar-based, therapeutic yoga program, used to treat&#xD;
      pelvic or genital pain, in up to 16 women. Women aged 21 years and older who report&#xD;
      persistent or recurrent pelvic or genital pain for at least 6 months that interferes with&#xD;
      sexual activity will be recruited from the San Francisco Bay Area. Those who meet eligibility&#xD;
      criteria will take part in a 6-week yoga therapy program designed by an expert yoga panel.&#xD;
      Women will attend twice-weekly group classes focusing on Iyengar-based yoga techniques that&#xD;
      have been carefully selected for their potential to improve women's genito-pelvic pain and&#xD;
      practice yoga at home one additional hour a week.&#xD;
&#xD;
      The investigators will evaluate changes in the severity and impact of women's pain using&#xD;
      validated questionnaires and diaries.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2014</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline in severity of pelvic pain after yoga therapy program.</measure>
    <time_frame>Baseline to 6-Weeks</time_frame>
    <description>Self-reported daily pain severity, as rated by Daily Pain Log (scale from 0-10).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in baseline sexual functioning after yoga therapy program.</measure>
    <time_frame>Baseline, 6-Weeks</time_frame>
    <description>We will use standard questionnaires to assess changes in sexual function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in baseline quality of life after yoga therapy program.</measure>
    <time_frame>Baseline, 6-Weeks</time_frame>
    <description>We will use standard questionnaires to assess changes in overall quality of life.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">16</enrollment>
  <condition>Pelvic Pain</condition>
  <arm_group>
    <arm_group_label>Yoga Therapy Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will attend twice-weekly group yoga classes and be instructed to practice yoga at home one additional hour a week, using a written manual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Yoga Therapy</intervention_name>
    <description>A 90-minute orientation session led by the yoga class instructors, followed by 90-minute group yoga classes twice weekly for 6 weeks. Classes will be led by an experienced instructor. Women will also be taught to avoid any habits that may worsen their genito-pelvic pain (e.g., straining their pelvic floor muscles).&#xD;
Participants will also be asked to practice yoga at home an additional hour per week throughout the 6-week yoga therapy program. Participants will be given a detailed written manual to use for home practice.</description>
    <arm_group_label>Yoga Therapy Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women aged 21 years or older who report difficulties with pelvic or genital pain for&#xD;
             at least 6 months&#xD;
&#xD;
          2. Report that their chronic pelvic or genital pain has had an adverse effect on their&#xD;
             interest in or ability to enjoy sexual activity&#xD;
&#xD;
          3. Report an eligible average daily pain intensity score after completion of a Daily Pain&#xD;
             Log for one week prior to baseline&#xD;
&#xD;
          4. Have an established primary care or gynecologic healthcare provider (to facilitate&#xD;
             medical follow-up of any health issues detected incidentally in the study or adverse&#xD;
             events that develop during the study)&#xD;
&#xD;
          5. Report prior clinical evaluation of their pelvic or genital pain by a health care&#xD;
             professional including at least a superficial pelvic exam&#xD;
&#xD;
          6. Willing to refrain from initiating other new clinical treatments that may affect their&#xD;
             pelvic or genital pain during the study period (6 weeks)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participation in organized yoga classes in the past 1 month, or any prior yoga therapy&#xD;
             directed specifically at pelvic or genital pain (regardless of timing)&#xD;
&#xD;
          2. Currently pregnant (by self-report or screening test), pregnant within the past 6&#xD;
             months, planning pregnancy during the study, or unwilling to use contraception (if not&#xD;
             postmenopausal) during the study&#xD;
&#xD;
          3. Diagnosed with an alternate cause of pain that is unlikely to respond to yoga and&#xD;
             requires another treatment modality, such as pelvic infection or a gynecologic&#xD;
             dermatosis&#xD;
&#xD;
          4. Surgery to the vulva, vagina, cervix, or pelvic organs within 6 months of screening,&#xD;
             or any prior history of cancer or irradiation to these structures&#xD;
&#xD;
          5. Initiation of or dose escalation of pharmacologic agents that may affect pelvic or&#xD;
             genital pain in the past 1 month (e.g., antidepressants, anticonvulsants,&#xD;
             anxiolytics)-women on stable dose for &gt;1 month are eligible&#xD;
&#xD;
          6. Use of formal psychological therapies specifically for pelvic or genital pain (e.g.,&#xD;
             systematic desensitization, sex therapy, cognitive therapy, relaxation therapy) within&#xD;
             1 month of screening&#xD;
&#xD;
          7. Use of formal behavioral therapies for pelvic or genital pain (e.g., pelvic floor&#xD;
             rehabilitation or biofeedback performed by a certified healthcare practitioner) within&#xD;
             1 month of screening&#xD;
&#xD;
          8. Unable to walk up a flight of stairs or at least 2 blocks on level ground (i.e.,&#xD;
             functional capacity &lt; 4 METs), or unable to get up from a supine to a standing&#xD;
             position without assistance in &lt;10 seconds&#xD;
&#xD;
          9. Currently involved in a malpractice suit or other litigation specifically related to&#xD;
             pelvic or genital pain&#xD;
&#xD;
         10. Participation in another interventional study that might interfere with or confound&#xD;
             study procedures, inability to sign an informed consent or fill out questionnaires, or&#xD;
             conflict with available yoga class dates&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Alison Huang, MD, MAS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California, San Francisco</affiliation>
  </overall_official>
  <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>September 2016</verification_date>
  <study_first_submitted>October 1, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2014</study_first_posted>
  <last_update_submitted>September 30, 2016</last_update_submitted>
  <last_update_submitted_qc>September 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 4, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pelvic Pain</keyword>
  <keyword>Genital Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pelvic Pain</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/NCT02261740
org study id: 14-13946
nct id: NCT02261740
lead sponsor: 
collaborator: 
has dmc: No
The POPPY Study is a pilot of an Iyengar-based, therapeutic yoga program, used to treat
      pelvic or genital pain, in up to 16 women. Women aged 21 years and older who report
      persistent or recurrent pelvic or genital pain for at least 6 months that interferes with
      sexual activity will be recruited from the San Francisco Bay Area. Those who meet eligibility
      criteria will take part in a 6-week yoga therapy program designed by an expert yoga panel.
      Women will attend twice-weekly group classes focusing on Iyengar-based yoga techniques that
      have been carefully selected for their potential to improve women's genito-pelvic pain and
      practice yoga at home one additional hour a week.

      The investigators will evaluate changes in the severity and impact of women's pain using
      validated questionnaires and diaries.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from baseline in severity of pelvic pain after yoga therapy program.
time frame: Baseline to 6-Weeks
description: Self-reported daily pain severity, as rated by Daily Pain Log (scale from 0-10).
measure: Change in baseline sexual functioning after yoga therapy program.
time frame: Baseline, 6-Weeks
description: We will use standard questionnaires to assess changes in sexual function.
measure: Change in baseline quality of life after yoga therapy program.
time frame: Baseline, 6-Weeks
description: We will use standard questionnaires to assess changes in overall quality of life.
arm group label: Yoga Therapy Group
arm group type: Experimental
description: Participants will attend twice-weekly group yoga classes and be instructed to practice yoga at home one additional hour a week, using a written manual.
intervention type: Behavioral
intervention name: Yoga Therapy
description: A 90-minute orientation session led by the yoga class instructors, followed by 90-minute group yoga classes twice weekly for 6 weeks. Classes will be led by an experienced instructor. Women will also be taught to avoid any habits that may worsen their genito-pelvic pain (e.g., straining their pelvic floor muscles).
Participants will also be asked to practice yoga at home an additional hour per week throughout the 6-week yoga therapy program. Participants will be given a detailed written manual to use for home practice.
arm group label: Yoga Therapy Group
criteria: 
gender: Female
minimum age: 21 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Alison Huang, MD, MAS
role: Principal Investigator
affiliation: University of California, San Francisco
facility: 
country: United States
responsible party type: Sponsor
mesh term: Pelvic Pain