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/NCT06021782</url>
    </required_header>
    <id_info>
      <org_study_id>HSR22513</org_study_id>
      <nct_id>NCT06021782</nct_id>
    </id_info>
    <brief_title>Characterization of the Pudendal Nerve With Transvaginal Ultrasonography</brief_title>
    <official_title>Characterization of the Pudendal Nerve With Transvaginal Ultrasonography</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>
        This is a feasibility study characterizing the ability of transvaginal ultrasonography to&#xD;
        identify the pudendal nerve. Today, the pudendal nerve block is typically accomplished&#xD;
        through blind landmark techniques, thus limiting its success. To date, there has never been&#xD;
        an attempt to determine if the visualization of the pudendal nerve would be possible using&#xD;
        transvaginal ultrasound with existing technology; nor to perform this procedure&#xD;
        transvaginally with the assistance of ultrasound.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a feasibility study characterizing the ability of transvaginal ultrasonography to&#xD;
        identify the pudendal nerve. The pudendal nerve is a sensory and motor nerve arising from the&#xD;
        sacral plexus, innervating the perineum. Anesthesia of the pudendal nerve (pudendal nerve&#xD;
        block) is used to assist during obstetrical procedures (forceps delivery, vaginal tear&#xD;
        repair), to improve discomfort associated with vaginal delivery when time is not sufficient&#xD;
        to place an epidural, and to reduce pain following certain urogynecological surgeries [1-4].&#xD;
        Pudendal nerve block is also used to manage chronic pain associated with pudendal neuralgia&#xD;
        [5]. Today, the pudendal nerve block is typically accomplished through blind landmark&#xD;
        techniques, thus limiting its success [6-7]. More recently, efforts have been made to attempt&#xD;
        this procedure with ultrasound from a more external approach transglutially, however this&#xD;
        method requires high level of technical skill and is associated with high failure rate when&#xD;
        compared to a blind landmark technique [8-10]. Other methods of accomplishing pudendal nerve&#xD;
        blocks include the use of fluoroscopy. However, these renders the procedure more costly and&#xD;
        subjects the patient to the inherent risk of radiation [11]. To date, there has never been an&#xD;
        attempt to determine if the visualization of the pudendal nerve would be possible using&#xD;
        transvaginal ultrasound with existing technology; nor to perform this procedure&#xD;
        transvaginally with the assistance of ultrasound.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 13, 2021</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>Observing the Pudendal Nerve</measure>
      <time_frame>day of study participate (1 day per participant)</time_frame>
      <description>We will use this study to determine if we can use transvaginal ultrasound to visualize the pudendal nerve through transvaginal ultrasound.</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">24</enrollment>
    <condition>Anesthesia</condition>
    <arm_group>
      <arm_group_label>All subjects</arm_group_label>
      <description>Patients scheduled to have their transvaginal ultrasound for medical reasons at the fetal care center and gynecology clinic will be asked to participate in this study. Also, patients undergoing pelvic floor surgery at either the Main OR or outpatient surgery center at UVA will be asked to participate.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>All subjects-Observation</intervention_name>
      <description>The sonographer or study team member will scan the lateral vaginal walls (Left and right) directing the probe slightly caudad in direction of the ischial spine (IS). The IS is very echogenic and easily identifiable (bony landmark). Anatomically, the pudendal nerve courses underneath the IS and travels with the vascular bundle of the pudendal artery and pudendal vein. The artery and the vein will be identified using color flow Doppler at the time of the scan. These landmarks, IS, pudendal artery and vein will serve as the basis for the identification of the pudendal nerve.</description>
      <arm_group_label>All subjects</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patient scheduled to undergo transvaginal ultrasound at the Fetal Care Center (FCC) or&#xD;
          Gynecology clinic. Or patients undergoing pelvic floor surgery at either the Main OR or&#xD;
          outpatient surgery center at UVA will be included. This includes surgeries performed by&#xD;
          surgeons in the Department of OBGYN, Division of Pelvic Medicine and Reconstructive&#xD;
          Surgery, and includes surgeries for repair of prolapse, urinary incontinence, fistula,&#xD;
          urethral diverticulum, or other pelvic floor issues.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Scheduled to undergo transvaginal ultrasound at the Fetal Care Center (FCC) or&#xD;
               Gynecology clinic&#xD;
  &#xD;
            -  Patients undergoing pelvic floor surgery at either the Main OR or outpatient surgery&#xD;
               center at UVA will be included. This includes surgeries performed by surgeons in the&#xD;
               Department of OBGYN, Division of Pelvic Medicine and Reconstructive Surgery, and&#xD;
               includes surgeries for repair of prolapse, urinary incontinence, fistula, urethral&#xD;
               diverticulum, or other pelvic floor issues.&#xD;
  &#xD;
            -  &gt;18 years age&#xD;
  &#xD;
            -  English-speaking&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          • Refusal to participate&#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>
    <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>
      <contact>
        <last_name>Monique Vaughan, MD</last_name>
        <phone>434-924-2103</phone>
        <email>mv4w@UVAHEALTH.ORG</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <reference>
      <citation>KOBAK AJ, EVANS EF, JOHNSON GR. Transvaginal pudendal nerve block; a simple procedure for effective anesthesia in operative vaginal delivery. Am J Obstet Gynecol. 1956 May;71(5):981-9. No abstract available.</citation>
      <PMID>13313599</PMID>
    </reference>
    <reference>
      <citation>Langhoff-Roos J, Lindmark G. Analgesia and maternal side effects of pudendal block at delivery. A comparison of three local anesthetics. Acta Obstet Gynecol Scand. 1985;64(3):269-72. doi: 10.3109/00016348509155127.</citation>
      <PMID>3893025</PMID>
    </reference>
    <reference>
      <citation>Arslan M, Yazici G, Dilek U. Pudendal nerve block for pain relief in episiotomy repair. Int J Gynaecol Obstet. 2004 Nov;87(2):151-2. doi: 10.1016/j.ijgo.2004.06.020. No abstract available.</citation>
      <PMID>15491563</PMID>
    </reference>
    <reference>
      <citation>Nikpoor P, Bain E. Analgesia for forceps delivery. Cochrane Database Syst Rev. 2013 Sep 30;9(9):CD008878. doi: 10.1002/14651858.CD008878.pub2.</citation>
      <PMID>24085633</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>pudendal nerve</keyword>
    <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/NCT06021782
  org study id: HSR22513
  nct id: NCT06021782
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This is a feasibility study characterizing the ability of transvaginal ultrasonography to
        identify the pudendal nerve. Today, the pudendal nerve block is typically accomplished
        through blind landmark techniques, thus limiting its success. To date, there has never been
        an attempt to determine if the visualization of the pudendal nerve would be possible using
        transvaginal ultrasound with existing technology; nor to perform this procedure
        transvaginally with the assistance of ultrasound.
  This is a feasibility study characterizing the ability of transvaginal ultrasonography to
        identify the pudendal nerve. The pudendal nerve is a sensory and motor nerve arising from the
        sacral plexus, innervating the perineum. Anesthesia of the pudendal nerve (pudendal nerve
        block) is used to assist during obstetrical procedures (forceps delivery, vaginal tear
        repair), to improve discomfort associated with vaginal delivery when time is not sufficient
        to place an epidural, and to reduce pain following certain urogynecological surgeries [1-4].
        Pudendal nerve block is also used to manage chronic pain associated with pudendal neuralgia
        [5]. Today, the pudendal nerve block is typically accomplished through blind landmark
        techniques, thus limiting its success [6-7]. More recently, efforts have been made to attempt
        this procedure with ultrasound from a more external approach transglutially, however this
        method requires high level of technical skill and is associated with high failure rate when
        compared to a blind landmark technique [8-10]. Other methods of accomplishing pudendal nerve
        blocks include the use of fluoroscopy. However, these renders the procedure more costly and
        subjects the patient to the inherent risk of radiation [11]. To date, there has never been an
        attempt to determine if the visualization of the pudendal nerve would be possible using
        transvaginal ultrasound with existing technology; nor to perform this procedure
        transvaginally with the assistance of ultrasound.
  observational model: Cohort
  time perspective: Prospective
  measure: Observing the Pudendal Nerve
  time frame: day of study participate (1 day per participant)
  description: We will use this study to determine if we can use transvaginal ultrasound to visualize the pudendal nerve through transvaginal ultrasound.
  arm group label: All subjects
  description: Patients scheduled to have their transvaginal ultrasound for medical reasons at the fetal care center and gynecology clinic will be asked to participate in this study. Also, patients undergoing pelvic floor surgery at either the Main OR or outpatient surgery center at UVA will be asked to participate.
  intervention type: Other
  intervention name: All subjects-Observation
  description: The sonographer or study team member will scan the lateral vaginal walls (Left and right) directing the probe slightly caudad in direction of the ischial spine (IS). The IS is very echogenic and easily identifiable (bony landmark). Anatomically, the pudendal nerve courses underneath the IS and travels with the vascular bundle of the pudendal artery and pudendal vein. The artery and the vein will be identified using color flow Doppler at the time of the scan. These landmarks, IS, pudendal artery and vein will serve as the basis for the identification of the pudendal nerve.
  arm group label: All subjects
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  status: Recruiting
  contact: 
  country: United States
  citation: KOBAK AJ, EVANS EF, JOHNSON GR. Transvaginal pudendal nerve block; a simple procedure for effective anesthesia in operative vaginal delivery. Am J Obstet Gynecol. 1956 May;71(5):981-9. No abstract available.
  PMID: 13313599
  citation: Langhoff-Roos J, Lindmark G. Analgesia and maternal side effects of pudendal block at delivery. A comparison of three local anesthetics. Acta Obstet Gynecol Scand. 1985;64(3):269-72. doi: 10.3109/00016348509155127.
  PMID: 3893025
  citation: Arslan M, Yazici G, Dilek U. Pudendal nerve block for pain relief in episiotomy repair. Int J Gynaecol Obstet. 2004 Nov;87(2):151-2. doi: 10.1016/j.ijgo.2004.06.020. No abstract available.
  PMID: 15491563
  citation: Nikpoor P, Bain E. Analgesia for forceps delivery. Cochrane Database Syst Rev. 2013 Sep 30;9(9):CD008878. doi: 10.1002/14651858.CD008878.pub2.
  PMID: 24085633
  responsible party type: Principal Investigator
  investigator affiliation: University of Virginia
  investigator full name: Monique Vaughan, MD
  investigator title: Assistant Professor
  sharing ipd: No