xml: <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/NCT06021769</url>
    </required_header>
    <id_info>
      <org_study_id>HSR220160</org_study_id>
      <nct_id>NCT06021769</nct_id>
    </id_info>
    <brief_title>Pessary Experience Study</brief_title>
    <official_title>Longitudinal Assessment of Pessary Experience</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Virginia</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Virginia</source>
    <oversight_info>
      <has_dmc>No</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>
        Pessaries are silicone devices inserted into the vagina for treatment of pelvic organ&#xD;
        prolapse or stress urinary incontinence. They are adequate treatment options for patients who&#xD;
        are poor surgical candidates, those who decline surgical intervention, or as a temporizing&#xD;
        measure in those ultimately planning surgery. Most studies suggest that about 75% of patients&#xD;
        are able to be successfully fit with a pessary, but about 50% discontinue pessary use within&#xD;
        12 months of initiation. The purpose of this study is to determine why pessaries are&#xD;
        discontinued.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pessaries are silicone devices inserted into the vagina for treatment of pelvic organ&#xD;
        prolapse or stress urinary incontinence. They are adequate treatment options for patients who&#xD;
        are poor surgical candidates, those who decline surgical intervention, or as a temporizing&#xD;
        measure in those ultimately planning surgery. Most studies suggest that about 75% of patients&#xD;
        are able to be successfully fit with a pessary, but about 50% discontinue pessary use within&#xD;
        12 months of initiation.&#xD;
  &#xD;
        Research concerning pessary discontinuation is currently focused on identifying factors that&#xD;
        will predict outcomes of pessary use. It is generally agreed upon that pessaries are one of&#xD;
        the favored option to conservatively treat pelvic organ prolapse or stress urinary&#xD;
        incontinence, but there is not sufficient consensus on the rate of discontinuation, factors&#xD;
        leading to discontinuation, and patient satisfaction.&#xD;
  &#xD;
        Most studies recorded reasons for discontinuation and any adverse events. Patients' reasons&#xD;
        for discontinuation of pessary use included frequent expulsion, difficulty removing pessary,&#xD;
        new or worsening urinary incontinence, vaginal erosion, and pain/discomfort1, 2, 3.&#xD;
        Significant side effects or adverse events included vaginal discharge and erosion1, 2, 3&#xD;
  &#xD;
        Several studies focused on anatomic and medical variables that were correlated to pessary&#xD;
        discontinuation. A univariate analysis of factors contributing to discontinuation conducted&#xD;
        by Yimphong et al.1 found that higher BMI and history of pelvic surgery were significant in&#xD;
        predicting discontinuation. Similarly, Panman2 et al. conducted a multivariate analysis that&#xD;
        found higher BMI was a significant factor. Panman et al. also found that both younger age and&#xD;
        weaker pelvic floor muscles were predictors for discontinuation. The former finding is&#xD;
        further supported by Umchanger et al.3, which cited that 33% of patients who discontinued&#xD;
        pessary use within three months were generally less than 65 years. Umchanger et al.&#xD;
        hypothesized that despite data suggesting that pessaries are as effective as surgery, younger&#xD;
        patients may maintain the misconception that pessaries are not as effective.&#xD;
  &#xD;
        Despite the data suggesting contributing factors such as BMI and age, none of the reviewed&#xD;
        studies captured the qualitative reasoning behind patients' decisions. Only a few of the&#xD;
        studies investigate patients' satisfaction with pessary use, quality of life, or opinion on&#xD;
        their treatment.&#xD;
  &#xD;
        Pessary use has been correlated to a wide variety of factors, such as a patient's medical&#xD;
        history, anatomic characteristics, beliefs about pessary use, and personal satisfaction with&#xD;
        treatment. Based on this review, a qualitative analysis of patient experience and priorities&#xD;
        as they decide to continue or discontinue pessary use would be incredibly helpful for&#xD;
        counseling and educating future patients when they are making treatment decisions about&#xD;
        pessaries.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 12, 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">December 2024</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Qualitative analysis</measure>
      <time_frame>up to 1 year after pessary fitting</time_frame>
      <description>Perform a patient-centered, qualitative analysis of pessary discontinuation</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pelvic Floor symptom improvement as related to quality of life</measure>
      <time_frame>up to 1 year after pessary fitting</time_frame>
      <description>Assess changes in pelvic floor symptoms and quality of life before and after pessary use as measured by validated questionnaires</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Discontinuation of pessaries</measure>
      <time_frame>up to 1 year after pessary fitting</time_frame>
      <description>Rates of discontinuation at 1 year</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Why do women discontinue using pessaries?</measure>
      <time_frame>up to 1 year after pessary fitting</time_frame>
      <description>Factors significantly associated with discontinuation</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">30</enrollment>
    <condition>Pelvic Organ Prolapse</condition>
    <condition>Stress Urinary Incontinence</condition>
    <arm_group>
      <arm_group_label>Women being fitted with pessaries</arm_group_label>
      <description>Women being fitted with pessaries as standard of care will be eligible to participate. They will be asked to complete a recorded verbal interview and written questionnaires the day they have their pessaries fitted and at their follow-up clinic appointments at 4-6 weeks, 3 months, 6 months, and 12 months. Another recorded video interview will be completed at the 12 month appointment.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Observational only</intervention_name>
      <description>No intervention</description>
      <arm_group_label>Women being fitted with pessaries</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Women in the area surrounding the University of Virginia who have stress urinary&#xD;
          incontinences or pelvic organ prolapse.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  English-speaking women aged 18 years or older&#xD;
  &#xD;
            -  Choosing to undergo a pessary fitting for symptomatic pelvic organ prolapse and/or&#xD;
               stress urinary incontinence at the University of Virginia Pelvic Medicine and&#xD;
               Reconstructive Surgery clinic&#xD;
  &#xD;
            -  Willingness and ability to comply with scheduled visits and study procedures.&#xD;
  &#xD;
            -  Successful pessary fitting&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Pregnant women&#xD;
  &#xD;
            -  Prisoners&#xD;
  &#xD;
            -  Cognitively impaired&#xD;
  &#xD;
            -  Non-English speaking subjects&#xD;
  &#xD;
            -  Patients who cannot comply with pessary check visits&#xD;
  &#xD;
            -  Active vaginal infection&#xD;
  &#xD;
            -  Vaginal malignancy&#xD;
  &#xD;
            -  Genitourinary tract fistula&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Monique Vaughan, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Assistant Professor</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Monique Vaughan, MD</last_name>
      <phone>4349261955</phone>
      <email>mv4w@UVAHEALTH.ORG</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Monique Vaughan, MD</last_name>
      <phone>4349242103</phone>
      <email>mv4w@UVAHEALTH.ORG</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Virginia</name>
        <address>
          <city>Charlottesville</city>
          <state>Virginia</state>
          <zip>22903</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>Yimphong T, Temtanakitpaisan T, Buppasiri P, Chongsomchai C, Kanchaiyaphum S. Discontinuation rate and adverse events after 1 year of vaginal pessary use in women with pelvic organ prolapse. Int Urogynecol J. 2018 Aug;29(8):1123-1128. doi: 10.1007/s00192-017-3445-x. Epub 2017 Aug 16.</citation>
      <PMID>28815277</PMID>
    </reference>
    <reference>
      <citation>Panman CM, Wiegersma M, Kollen BJ, Burger H, Berger MY, Dekker JH. Predictors of unsuccessful pessary fitting in women with prolapse: a cross-sectional study in general practice. Int Urogynecol J. 2017 Feb;28(2):307-313. doi: 10.1007/s00192-016-3107-4. Epub 2016 Aug 15.</citation>
      <PMID>27525693</PMID>
    </reference>
    <reference>
      <citation>Umachanger JK, Marcussen ML, Boggild H, Kjaergaard N, Glavind K. First-line treatment of pelvic organ prolapse and discontinuation of pessary treatment. Int Urogynecol J. 2020 Sep;31(9):1813-1819. doi: 10.1007/s00192-020-04338-w. Epub 2020 May 24.</citation>
      <PMID>32447418</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Virginia</investigator_affiliation>
      <investigator_full_name>Monique Vaughan, MD</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>pessary</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urinary Incontinence</mesh_term>
      <mesh_term>Urinary Incontinence, Stress</mesh_term>
      <mesh_term>Prolapse</mesh_term>
      <mesh_term>Pelvic Organ Prolapse</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06021769
  org study id: HSR220160
  nct id: NCT06021769
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Pessaries are silicone devices inserted into the vagina for treatment of pelvic organ
        prolapse or stress urinary incontinence. They are adequate treatment options for patients who
        are poor surgical candidates, those who decline surgical intervention, or as a temporizing
        measure in those ultimately planning surgery. Most studies suggest that about 75% of patients
        are able to be successfully fit with a pessary, but about 50% discontinue pessary use within
        12 months of initiation. The purpose of this study is to determine why pessaries are
        discontinued.
  Pessaries are silicone devices inserted into the vagina for treatment of pelvic organ
        prolapse or stress urinary incontinence. They are adequate treatment options for patients who
        are poor surgical candidates, those who decline surgical intervention, or as a temporizing
        measure in those ultimately planning surgery. Most studies suggest that about 75% of patients
        are able to be successfully fit with a pessary, but about 50% discontinue pessary use within
        12 months of initiation.
  
        Research concerning pessary discontinuation is currently focused on identifying factors that
        will predict outcomes of pessary use. It is generally agreed upon that pessaries are one of
        the favored option to conservatively treat pelvic organ prolapse or stress urinary
        incontinence, but there is not sufficient consensus on the rate of discontinuation, factors
        leading to discontinuation, and patient satisfaction.
  
        Most studies recorded reasons for discontinuation and any adverse events. Patients' reasons
        for discontinuation of pessary use included frequent expulsion, difficulty removing pessary,
        new or worsening urinary incontinence, vaginal erosion, and pain/discomfort1, 2, 3.
        Significant side effects or adverse events included vaginal discharge and erosion1, 2, 3
  
        Several studies focused on anatomic and medical variables that were correlated to pessary
        discontinuation. A univariate analysis of factors contributing to discontinuation conducted
        by Yimphong et al.1 found that higher BMI and history of pelvic surgery were significant in
        predicting discontinuation. Similarly, Panman2 et al. conducted a multivariate analysis that
        found higher BMI was a significant factor. Panman et al. also found that both younger age and
        weaker pelvic floor muscles were predictors for discontinuation. The former finding is
        further supported by Umchanger et al.3, which cited that 33% of patients who discontinued
        pessary use within three months were generally less than 65 years. Umchanger et al.
        hypothesized that despite data suggesting that pessaries are as effective as surgery, younger
        patients may maintain the misconception that pessaries are not as effective.
  
        Despite the data suggesting contributing factors such as BMI and age, none of the reviewed
        studies captured the qualitative reasoning behind patients' decisions. Only a few of the
        studies investigate patients' satisfaction with pessary use, quality of life, or opinion on
        their treatment.
  
        Pessary use has been correlated to a wide variety of factors, such as a patient's medical
        history, anatomic characteristics, beliefs about pessary use, and personal satisfaction with
        treatment. Based on this review, a qualitative analysis of patient experience and priorities
        as they decide to continue or discontinue pessary use would be incredibly helpful for
        counseling and educating future patients when they are making treatment decisions about
        pessaries.
  observational model: Cohort
  time perspective: Prospective
  measure: Qualitative analysis
  time frame: up to 1 year after pessary fitting
  description: Perform a patient-centered, qualitative analysis of pessary discontinuation
  measure: Pelvic Floor symptom improvement as related to quality of life
  time frame: up to 1 year after pessary fitting
  description: Assess changes in pelvic floor symptoms and quality of life before and after pessary use as measured by validated questionnaires
  measure: Discontinuation of pessaries
  time frame: up to 1 year after pessary fitting
  description: Rates of discontinuation at 1 year
  measure: Why do women discontinue using pessaries?
  time frame: up to 1 year after pessary fitting
  description: Factors significantly associated with discontinuation
  arm group label: Women being fitted with pessaries
  description: Women being fitted with pessaries as standard of care will be eligible to participate. They will be asked to complete a recorded verbal interview and written questionnaires the day they have their pessaries fitted and at their follow-up clinic appointments at 4-6 weeks, 3 months, 6 months, and 12 months. Another recorded video interview will be completed at the 12 month appointment.
  intervention type: Other
  intervention name: Observational only
  description: No intervention
  arm group label: Women being fitted with pessaries
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Monique Vaughan, MD
  role: Principal Investigator
  affiliation: Assistant Professor
  last name: Monique Vaughan, MD
  phone: 4349261955
  email: mv4w@UVAHEALTH.ORG
  last name: Monique Vaughan, MD
  phone: 4349242103
  email: mv4w@UVAHEALTH.ORG
  facility: 
  status: Recruiting
  country: United States
  citation: Yimphong T, Temtanakitpaisan T, Buppasiri P, Chongsomchai C, Kanchaiyaphum S. Discontinuation rate and adverse events after 1 year of vaginal pessary use in women with pelvic organ prolapse. Int Urogynecol J. 2018 Aug;29(8):1123-1128. doi: 10.1007/s00192-017-3445-x. Epub 2017 Aug 16.
  PMID: 28815277
  citation: Panman CM, Wiegersma M, Kollen BJ, Burger H, Berger MY, Dekker JH. Predictors of unsuccessful pessary fitting in women with prolapse: a cross-sectional study in general practice. Int Urogynecol J. 2017 Feb;28(2):307-313. doi: 10.1007/s00192-016-3107-4. Epub 2016 Aug 15.
  PMID: 27525693
  citation: Umachanger JK, Marcussen ML, Boggild H, Kjaergaard N, Glavind K. First-line treatment of pelvic organ prolapse and discontinuation of pessary treatment. Int Urogynecol J. 2020 Sep;31(9):1813-1819. doi: 10.1007/s00192-020-04338-w. Epub 2020 May 24.
  PMID: 32447418
  responsible party type: Principal Investigator
  investigator affiliation: University of Virginia
  investigator full name: Monique Vaughan, MD
  investigator title: Assistant Professor
  mesh term: Urinary Incontinence
  mesh term: Urinary Incontinence, Stress
  mesh term: Prolapse
  mesh term: Pelvic Organ Prolapse
  sharing ipd: No