<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/NCT03257670</url>
  </required_header>
  <id_info>
    <org_study_id>UC Laser</org_study_id>
    <nct_id>NCT03257670</nct_id>
  </id_info>
  <brief_title>Fractional CO2 Laser Therapy Versus 4% Topical Lidocaine Gel for Dyspareunia in Breast Cancer Survivors</brief_title>
  <acronym>BCLS</acronym>
  <official_title>Prospective Randomized Trial Comparing Treatment of Dyspareunia With Fractional CO2 Laser Therapy Versus 4% Topical Lidocaine Gel in the Setting of Breast Cancer Survivors.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Syneron Candela</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Cincinnati</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This trial seeks to determine if therapy with a CO2 laser to the vagina is more effective&#xD;
      than lidocaine to the opening of the vagina before intercourse to reduce painful intercourse&#xD;
      in women who are breast cancer survivors. This study will also be looking at whether or not&#xD;
      the CO2 laser improves pelvic floor function, bowel and bladder function, and sexual function&#xD;
      before and after treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a randomized trial to determine the comparative effectiveness of the CO2RE laser&#xD;
      device relative to topical lidocaine in treating dyspareunia among breast cancer survivors.&#xD;
      The large and growing population of breast cancer survivors experience a significant burden&#xD;
      of urogenital symptoms including dyspareunia. Several studies have evaluated the feasibility&#xD;
      and effectiveness of CO2 lasers for the treatment of symptomatic vulvovaginal atrophy in&#xD;
      postmenopausal women suggesting improvements in atrophy symptoms with favorable histological&#xD;
      and microscopic changes. There is little know about the effectiveness of CO2 laser therapy in&#xD;
      breast cancer survivors.&#xD;
&#xD;
      Patients who are breast cancer survivors experiencing dyspareunia and desiring intervention&#xD;
      will be randomized to two cohorts: (1) Treatment with the CO2RE laser or (2) application of&#xD;
      4% aqueous lidocaine applied to the vulvar vestibule for 3 minutes before vaginal&#xD;
      penetration. The primary outcome will be the overall as well as lubrication, satisfaction,&#xD;
      and pain domain scores on the Female Sexual Function Index instrument. Secondary outcomes&#xD;
      will be according to other validated pain and pelvic floor symptom instruments.&#xD;
&#xD;
      Following initiation of treatment, both groups will follow up at one-week, 1-month, 3-months,&#xD;
      and 6-months. At the 3-month assessment, subjects in the lidocaine arm will be given the&#xD;
      option to undergo CO2RE laser therapy. A combination of validated and non-validated physical&#xD;
      exam and survey instruments will be utilized at each visit in order to assess pelvic floor&#xD;
      function, bowel and bladder function, and sexual function before and after treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">March 20, 2018</start_date>
  <completion_date type="Anticipated">June 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2022</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>
    <intervention_model_description>Subjects will be randomized to two treatment cohorts (each with 35 patients): (1) treatment with the CO2RE laser or; (2) treatments of 4% aqueous lidocaine applied to the vulvar vestibule for 3 minutes before vaginal penetration. Both cohorts will have four follow-up assessments following initiation of treatment: (1) One-week post treatment initiation; (2) 1-month post treatment initiation; (3) 3-months post treatment initiation and; (4) 6-months post laser-only treatment initiation. At the 3-month assessment, subjects in the lidocaine arm will be allowed to try the CO2RE laser therapy. In doing this, an imbedded crossover trial is included that will allow assessment of subject decision-satisfaction between the two therapy approaches. The primary outcome will be the overall and lubrication, satisfaction, and pain domain scores on the Female Sexual Function Index instrument. Secondary outcomes will be other validated pain and pelvic floor symptom instruments.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Female Sexual Function Index (FSFI) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.</measure>
    <time_frame>9 months</time_frame>
    <description>The Female Sexual Function Index (FSFI) is a survey instrument used to determine the level of sexual function or dysfunction in females. It is comprised of a 19 item questionnaire focused on sexual functioning. There are six domains assessed: desire, arousal, lubrication, orgasm, satisfaction, and pain. The subject is to consider each of the questions in the context of the previous 4 weeks. The scores of each of the domains are then calculated into a final score.&#xD;
Initial and follow-up assessments will allow comparisons across this instrument as well as all the secondary and other pre-specified outcome measures.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numeric Pain Rating Scale (NPRS) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.</measure>
    <time_frame>9 months</time_frame>
    <description>The Numeric Pain Rating Scale (NPRS) is a measure of pain intensity in adults.The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. &quot;no pain&quot;) to '10' representing the other pain extreme (e.g. &quot;pain as bad as you can imagine&quot; or &quot;worst pain imaginable&quot;).The NPRS can be administered verbally (therefore also by telephone) or graphically for self-completion. Scores range from 0-10 with higher numbers representing higher pain intensity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incontinence Severity Index (ISI) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.</measure>
    <time_frame>9 months</time_frame>
    <description>The Incontinence Severity Index (ISI) consists of two questions, regarding frequency and amount of leakage. It categorizes urinary incontinence (UI) into none, slight, moderate, severe, and very severe. It assess the frequency (from 0-4): (0-never, 1-less than once a month, 2-a few times a month, 3-a few times a week, 4-every day and/or night ), and amount (from 0-3) of urine leakage: 0-none, 1-drops, 2-small splashes, 3-more. The index value is from 0-12 obtained by multiplying the numbers responded in the two questions with categories of urinary incontinence severity of: None (0), Slight (1-2), Moderate (3-6), Severe (8-9), Very severe (12).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>3 Incontinence Questions (3-IQ) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.</measure>
    <time_frame>9 months</time_frame>
    <description>The 3 Incontinence Questions (3-IQ) is a survey instrument that is used to determine if a patient has stress urinary incontinence (SUI), urge urinary incontinence (UUI), or mixed urinary incontinence (MUI). The subject is to consider each of the questions in the context of the previous 3 months.The first question asks if the patient has every leaked urine. The second question asks the patient to indicate if she has leaked urine with any of the following: activity, urge, or without activity or urge. The Third question asks which form of urinary leakage was most common. The response to question 3 is then used to determine if the patient has: 1) Stress only or mostly stress, 2) urge only or mostly urge, 3) other cause, or 4) mixed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Colon Rectal Anal Distress Inventory (CRADI) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.</measure>
    <time_frame>9 months</time_frame>
    <description>The Colon Rectal Anal Distress Inventory (CRADI) is a survey instrument used to determine the level and severity of bowel symptoms. It consists of 17 questions inquiring to specific questions regarding bowel symptoms. Total score out of 400, with higher scores indicating more bowel symptoms.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Severity (PGI-S) score before treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.</measure>
    <time_frame>9 months</time_frame>
    <description>The PGI-S are 1 question assessments of overall condition severity before implementation of therapy measured on a 7-point response scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impression of Improvement (PGI-I) score after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.</measure>
    <time_frame>9 months</time_frame>
    <description>The Patient Global Impression of Improvement (PGI-I) is 1 question assessment of overall condition improvement since implementation of therapy measured on a 7-point response scale.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Satisfaction with Decision (SDS) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.</measure>
    <time_frame>9 months</time_frame>
    <description>The Satisfaction with Decision (SDS) was developed to measure patient satisfaction with health care decisions. The SDS is a 6-item questionnaire with a 5-point response scale with higher scores indicating higher overall satisfaction.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Symptom inventory (number of voids/day, pads/day, etc.)</measure>
    <time_frame>9 months</time_frame>
    <description>Symptom inventory (number of voids/day, pads/day, etc.) will be collected and available for comparison by cohort prior to and after treatment.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">70</enrollment>
  <condition>Dyspareunia</condition>
  <arm_group>
    <arm_group_label>CO2RE Laser</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will undergo vaginal CO2 laser therapy for a total of three (3) treatments with one month between treatments.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>4% Topical Lidocaine Gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will be given 4% topical lidocaine gel to take home. The patient will apply the 4% lidocaine gel to the outside and opening of the vagina for 3 minutes before vaginal penetration. The patient will continue using the numbing gel prior to vaginal penetration for the extent of the study (3 months).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>4% Topical Lidocaine Gel</intervention_name>
    <description>This group will be given 4% topical lidocaine gel to take home. The patient will apply the 4% lidocaine gel to the outside and opening of the vagina for 3 minutes before vaginal penetration. The patient will continue using the numbing gel prior to vaginal penetration for the extent of the study (3 months).</description>
    <arm_group_label>4% Topical Lidocaine Gel</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CO2RE fractional laser therapy</intervention_name>
    <description>This group will undergo vaginal CO2 laser therapy for a total of three (3) treatments with one month between treatments.</description>
    <arm_group_label>CO2RE Laser</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects included must be female breast cancer survivors over the age of 18, sexually&#xD;
             active (at least 4 episodes of sexual intercourse per month), and find intercourse&#xD;
             painful. Subjects must also be English speaking and able to give informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects will be excluded if pregnant, has not had breast cancer, does not have&#xD;
             painful intercourse secondary to treatment received for their breast cancer, is not&#xD;
             English speaking, or lacks the ability to sign informed consent.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Subjects must be female who have undergone treatment for breast cancer that have dyspareunia secondary to the treatment they received for breast cancer.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James L Whiteside, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Cincinnati</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>James L Whiteside, MD</last_name>
    <phone>513-475-8713</phone>
    <email>whitesje@ucmail.uc.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Carson T Kaeser, MD</last_name>
    <phone>513-475-8713</phone>
    <email>carson.kaeser@thechristhospital.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Cincinnati</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45267</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>James L Whiteside, MD</last_name>
      <phone>513-475-8713</phone>
      <email>whitesje@ucmail.uc.edu</email>
    </contact>
    <contact_backup>
      <last_name>Carson T Kaeser, MD</last_name>
      <phone>513-585-3474</phone>
      <email>carson.kaeser@thechristhospital.com</email>
    </contact_backup>
    <investigator>
      <last_name>James L Whiteside, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Jamie D Lewis, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Carson T Kaeser, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Cynthia Dehlinger, CNM</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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    <citation>Miller KD, Siegel RL, Lin CC, Mariotto AB, Kramer JL, Rowland JH, Stein KD, Alteri R, Jemal A. Cancer treatment and survivorship statistics, 2016. CA Cancer J Clin. 2016 Jul;66(4):271-89. doi: 10.3322/caac.21349. Epub 2016 Jun 2.</citation>
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    <citation>Maiorino MI, Chiodini P, Bellastella G, Giugliano D, Esposito K. Sexual dysfunction in women with cancer: a systematic review with meta-analysis of studies using the Female Sexual Function Index. Endocrine. 2016 Nov;54(2):329-341. doi: 10.1007/s12020-015-0812-6. Epub 2015 Dec 7.</citation>
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    <citation>Mazzarello S, Hutton B, Ibrahim MFK, Jacobs C, Shorr R, Smith S, Ng T, Clemons M. Management of urogenital atrophy in breast cancer patients: a systematic review of available evidence from randomized trials. Breast Cancer Res Treat. 2015 Jul;152(1):1-8. doi: 10.1007/s10549-015-3434-z. Epub 2015 May 24.</citation>
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    <citation>Falk SJ, Bober S. Vaginal Health During Breast Cancer Treatment. Curr Oncol Rep. 2016 May;18(5):32. doi: 10.1007/s11912-016-0517-x.</citation>
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    <citation>Baumgart J, Nilsson K, Stavreus-Evers A, Kask K, Villman K, Lindman H, Kallak T, Sundstrom-Poromaa I. Urogenital disorders in women with adjuvant endocrine therapy after early breast cancer. Am J Obstet Gynecol. 2011 Jan;204(1):26.e1-7. doi: 10.1016/j.ajog.2010.08.035. Epub 2010 Oct 14.</citation>
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    <citation>Sinha A, Ewies AA. Non-hormonal topical treatment of vulvovaginal atrophy: an up-to-date overview. Climacteric. 2013 Jun;16(3):305-12. doi: 10.3109/13697137.2012.756466. Epub 2013 Jan 8.</citation>
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    <citation>Perino A, Calligaro A, Forlani F, Tiberio C, Cucinella G, Svelato A, Saitta S, Calagna G. Vulvo-vaginal atrophy: a new treatment modality using thermo-ablative fractional CO2 laser. Maturitas. 2015 Mar;80(3):296-301. doi: 10.1016/j.maturitas.2014.12.006. Epub 2014 Dec 25.</citation>
    <PMID>25596815</PMID>
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  <reference>
    <citation>Salvatore S, Nappi RE, Zerbinati N, Calligaro A, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. A 12-week treatment with fractional CO2 laser for vulvovaginal atrophy: a pilot study. Climacteric. 2014 Aug;17(4):363-9. doi: 10.3109/13697137.2014.899347. Epub 2014 Jun 5.</citation>
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    <citation>Salvatore S, Nappi RE, Parma M, Chionna R, Lagona F, Zerbinati N, Ferrero S, Origoni M, Candiani M, Leone Roberti Maggiore U. Sexual function after fractional microablative CO(2) laser in women with vulvovaginal atrophy. Climacteric. 2015 Apr;18(2):219-25. doi: 10.3109/13697137.2014.975197. Epub 2014 Dec 16.</citation>
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    <citation>Zerbinati N, Serati M, Origoni M, Candiani M, Iannitti T, Salvatore S, Marotta F, Calligaro A. Microscopic and ultrastructural modifications of postmenopausal atrophic vaginal mucosa after fractional carbon dioxide laser treatment. Lasers Med Sci. 2015 Jan;30(1):429-36. doi: 10.1007/s10103-014-1677-2. Epub 2014 Nov 20.</citation>
    <PMID>25410301</PMID>
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    <citation>Bump RC, Mattiasson A, Bo K, Brubaker LP, DeLancey JO, Klarskov P, Shull BL, Smith AR. The standardization of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol. 1996 Jul;175(1):10-7. doi: 10.1016/s0002-9378(96)70243-0.</citation>
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    <citation>Sandvik H, Hunskaar S, Seim A, Hermstad R, Vanvik A, Bratt H. Validation of a severity index in female urinary incontinence and its implementation in an epidemiological survey. J Epidemiol Community Health. 1993 Dec;47(6):497-9. doi: 10.1136/jech.47.6.497.</citation>
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    <citation>Childs JD, Piva SR, Fritz JM. Responsiveness of the numeric pain rating scale in patients with low back pain. Spine (Phila Pa 1976). 2005 Jun 1;30(11):1331-4. doi: 10.1097/01.brs.0000164099.92112.29.</citation>
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    <citation>Yalcin I, Bump RC. Validation of two global impression questionnaires for incontinence. Am J Obstet Gynecol. 2003 Jul;189(1):98-101. doi: 10.1067/mob.2003.379.</citation>
    <PMID>12861145</PMID>
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    <citation>Sung VW, Kauffman N, Raker CA, Myers DL, Clark MA. Validation of decision-making outcomes for female pelvic floor disorders. Am J Obstet Gynecol. 2008 May;198(5):575.e1-6. doi: 10.1016/j.ajog.2007.12.035. Epub 2008 Mar 7.</citation>
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    <citation>Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.</citation>
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    <citation>Sandvik H, Espuna M, Hunskaar S. Validity of the incontinence severity index: comparison with pad-weighing tests. Int Urogynecol J Pelvic Floor Dysfunct. 2006 Sep;17(5):520-4. doi: 10.1007/s00192-005-0060-z. Epub 2006 Mar 18.</citation>
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    <citation>Brown JS, Bradley CS, Subak LL, Richter HE, Kraus SR, Brubaker L, Lin F, Vittinghoff E, Grady D; Diagnostic Aspects of Incontinence Study (DAISy) Research Group. The sensitivity and specificity of a simple test to distinguish between urge and stress urinary incontinence. Ann Intern Med. 2006 May 16;144(10):715-23. doi: 10.7326/0003-4819-144-10-200605160-00005.</citation>
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  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>September 27, 2021</last_update_submitted>
  <last_update_submitted_qc>September 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Cincinnati</investigator_affiliation>
    <investigator_full_name>James Whiteside</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Dyspareunia</keyword>
  <keyword>Laser</keyword>
  <keyword>CO2</keyword>
  <keyword>Breast Cancer</keyword>
  <keyword>Vaginal Atrophy</keyword>
  <keyword>Lidocaine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspareunia</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lidocaine</mesh_term>
  </intervention_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/NCT03257670
org study id: UC Laser
nct id: NCT03257670
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This trial seeks to determine if therapy with a CO2 laser to the vagina is more effective
      than lidocaine to the opening of the vagina before intercourse to reduce painful intercourse
      in women who are breast cancer survivors. This study will also be looking at whether or not
      the CO2 laser improves pelvic floor function, bowel and bladder function, and sexual function
      before and after treatment.
This is a randomized trial to determine the comparative effectiveness of the CO2RE laser
      device relative to topical lidocaine in treating dyspareunia among breast cancer survivors.
      The large and growing population of breast cancer survivors experience a significant burden
      of urogenital symptoms including dyspareunia. Several studies have evaluated the feasibility
      and effectiveness of CO2 lasers for the treatment of symptomatic vulvovaginal atrophy in
      postmenopausal women suggesting improvements in atrophy symptoms with favorable histological
      and microscopic changes. There is little know about the effectiveness of CO2 laser therapy in
      breast cancer survivors.

      Patients who are breast cancer survivors experiencing dyspareunia and desiring intervention
      will be randomized to two cohorts: (1) Treatment with the CO2RE laser or (2) application of
      4% aqueous lidocaine applied to the vulvar vestibule for 3 minutes before vaginal
      penetration. The primary outcome will be the overall as well as lubrication, satisfaction,
      and pain domain scores on the Female Sexual Function Index instrument. Secondary outcomes
      will be according to other validated pain and pelvic floor symptom instruments.

      Following initiation of treatment, both groups will follow up at one-week, 1-month, 3-months,
      and 6-months. At the 3-month assessment, subjects in the lidocaine arm will be given the
      option to undergo CO2RE laser therapy. A combination of validated and non-validated physical
      exam and survey instruments will be utilized at each visit in order to assess pelvic floor
      function, bowel and bladder function, and sexual function before and after treatment.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Subjects will be randomized to two treatment cohorts (each with 35 patients): (1) treatment with the CO2RE laser or; (2) treatments of 4% aqueous lidocaine applied to the vulvar vestibule for 3 minutes before vaginal penetration. Both cohorts will have four follow-up assessments following initiation of treatment: (1) One-week post treatment initiation; (2) 1-month post treatment initiation; (3) 3-months post treatment initiation and; (4) 6-months post laser-only treatment initiation. At the 3-month assessment, subjects in the lidocaine arm will be allowed to try the CO2RE laser therapy. In doing this, an imbedded crossover trial is included that will allow assessment of subject decision-satisfaction between the two therapy approaches. The primary outcome will be the overall and lubrication, satisfaction, and pain domain scores on the Female Sexual Function Index instrument. Secondary outcomes will be other validated pain and pelvic floor symptom instruments.
primary purpose: Treatment
masking: None (Open Label)
measure: Female Sexual Function Index (FSFI) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.
time frame: 9 months
description: The Female Sexual Function Index (FSFI) is a survey instrument used to determine the level of sexual function or dysfunction in females. It is comprised of a 19 item questionnaire focused on sexual functioning. There are six domains assessed: desire, arousal, lubrication, orgasm, satisfaction, and pain. The subject is to consider each of the questions in the context of the previous 4 weeks. The scores of each of the domains are then calculated into a final score.
Initial and follow-up assessments will allow comparisons across this instrument as well as all the secondary and other pre-specified outcome measures.
measure: Numeric Pain Rating Scale (NPRS) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.
time frame: 9 months
description: The Numeric Pain Rating Scale (NPRS) is a measure of pain intensity in adults.The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").The NPRS can be administered verbally (therefore also by telephone) or graphically for self-completion. Scores range from 0-10 with higher numbers representing higher pain intensity.
measure: Incontinence Severity Index (ISI) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.
time frame: 9 months
description: The Incontinence Severity Index (ISI) consists of two questions, regarding frequency and amount of leakage. It categorizes urinary incontinence (UI) into none, slight, moderate, severe, and very severe. It assess the frequency (from 0-4): (0-never, 1-less than once a month, 2-a few times a month, 3-a few times a week, 4-every day and/or night ), and amount (from 0-3) of urine leakage: 0-none, 1-drops, 2-small splashes, 3-more. The index value is from 0-12 obtained by multiplying the numbers responded in the two questions with categories of urinary incontinence severity of: None (0), Slight (1-2), Moderate (3-6), Severe (8-9), Very severe (12).
measure: 3 Incontinence Questions (3-IQ) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.
time frame: 9 months
description: The 3 Incontinence Questions (3-IQ) is a survey instrument that is used to determine if a patient has stress urinary incontinence (SUI), urge urinary incontinence (UUI), or mixed urinary incontinence (MUI). The subject is to consider each of the questions in the context of the previous 3 months.The first question asks if the patient has every leaked urine. The second question asks the patient to indicate if she has leaked urine with any of the following: activity, urge, or without activity or urge. The Third question asks which form of urinary leakage was most common. The response to question 3 is then used to determine if the patient has: 1) Stress only or mostly stress, 2) urge only or mostly urge, 3) other cause, or 4) mixed.
measure: Colon Rectal Anal Distress Inventory (CRADI) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.
time frame: 9 months
description: The Colon Rectal Anal Distress Inventory (CRADI) is a survey instrument used to determine the level and severity of bowel symptoms. It consists of 17 questions inquiring to specific questions regarding bowel symptoms. Total score out of 400, with higher scores indicating more bowel symptoms.
measure: Patient Global Impression of Severity (PGI-S) score before treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.
time frame: 9 months
description: The PGI-S are 1 question assessments of overall condition severity before implementation of therapy measured on a 7-point response scale.
measure: Patient Global Impression of Improvement (PGI-I) score after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.
time frame: 9 months
description: The Patient Global Impression of Improvement (PGI-I) is 1 question assessment of overall condition improvement since implementation of therapy measured on a 7-point response scale.
measure: Satisfaction with Decision (SDS) score before and after treatment with topical lidocaine ointment or transvaginal CO2 laser among breast cancer survivors with dyspareunia.
time frame: 9 months
description: The Satisfaction with Decision (SDS) was developed to measure patient satisfaction with health care decisions. The SDS is a 6-item questionnaire with a 5-point response scale with higher scores indicating higher overall satisfaction.
measure: Symptom inventory (number of voids/day, pads/day, etc.)
time frame: 9 months
description: Symptom inventory (number of voids/day, pads/day, etc.) will be collected and available for comparison by cohort prior to and after treatment.
arm group label: CO2RE Laser
arm group type: Active Comparator
description: This group will undergo vaginal CO2 laser therapy for a total of three (3) treatments with one month between treatments.
arm group label: 4% Topical Lidocaine Gel
arm group type: Active Comparator
description: This group will be given 4% topical lidocaine gel to take home. The patient will apply the 4% lidocaine gel to the outside and opening of the vagina for 3 minutes before vaginal penetration. The patient will continue using the numbing gel prior to vaginal penetration for the extent of the study (3 months).
intervention type: Drug
intervention name: 4% Topical Lidocaine Gel
description: This group will be given 4% topical lidocaine gel to take home. The patient will apply the 4% lidocaine gel to the outside and opening of the vagina for 3 minutes before vaginal penetration. The patient will continue using the numbing gel prior to vaginal penetration for the extent of the study (3 months).
arm group label: 4% Topical Lidocaine Gel
intervention type: Device
intervention name: CO2RE fractional laser therapy
description: This group will undergo vaginal CO2 laser therapy for a total of three (3) treatments with one month between treatments.
arm group label: CO2RE Laser
criteria: 
gender: Female
gender based: Yes
gender description: Subjects must be female who have undergone treatment for breast cancer that have dyspareunia secondary to the treatment they received for breast cancer.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: James L Whiteside, MD
role: Principal Investigator
affiliation: University of Cincinnati
last name: James L Whiteside, MD
phone: 513-475-8713
email: whitesje@ucmail.uc.edu
last name: Carson T Kaeser, MD
phone: 513-475-8713
email: carson.kaeser@thechristhospital.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
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country: United States
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responsible party type: Principal Investigator
investigator affiliation: University of Cincinnati
investigator full name: James Whiteside
investigator title: Principal Investigator
mesh term: Dyspareunia
mesh term: Lidocaine
sharing ipd: No