<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/NCT04436172</url>
  </required_header>
  <id_info>
    <org_study_id>KarchiMDC</org_study_id>
    <nct_id>NCT04436172</nct_id>
  </id_info>
  <brief_title>Spinal Anesthesia Facilitated Sexual Intercourse As A Treatment Option For Vaginismus</brief_title>
  <official_title>Spinal Anesthesia Facilitated Sexual Intercourse As A Treatment Option For Vaginismus And Its Effect On Female Sexual Dysfunction As Assessed By Female Sexual Functioning Index (Fsfi) - A Pre-Post Intervention Design Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karachi Medical and Dental College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Aziz Medical Center</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karachi Medical and Dental College</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Painful sex continues to be a relationship issue and can lead to marital dys-harmony. Other&#xD;
      consequences include infertility, low self-esteem, depression and anxiety.Our study shows&#xD;
      that spinal anesthesia is an effective last resort management option in women with&#xD;
      vaginismus. As a one-off treatment spinal anesthesia provides hope for such couples and&#xD;
      brings about a positive change in their relationships.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Actual">December 31, 2017</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>successful sexual intercourse</measure>
    <time_frame>1 year</time_frame>
    <description>whether couple was able to have sexual intercourse after treatment</description>
  </primary_outcome>
  <primary_outcome>
    <measure>improvement in Female sexual functioning index</measure>
    <time_frame>1 year</time_frame>
    <description>Female sexual function index (FSFI) questionnaire consists of 19 questions that assess 6 domains to assess sexual feelings and responses during the past 4 weeks.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>depression and relationship satisfaction</measure>
    <time_frame>1 year</time_frame>
    <description>Depression was assessed by Zung's score. Zung's Self-Rating Depression Scale is a twenty item likert scale with raw score that ranges from 20 to 80. There are 20 items on the scale that rate the four common characteristics of depression: the pervasive effect, the physiological equivalents, other disturbances, and psychomotor activities.&#xD;
Relationaship assessment was assesed by relationship assessment score.The Relationship Assessment Scale (RAS) is a brief measure of global relationship satisfaction.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Vaginismus</condition>
  <arm_group>
    <arm_group_label>pre intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Before intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>post intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Received soinal anesthesia</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>spinal anesthesia</intervention_name>
    <description>The spinal anesthesia was given by a trained anesthetist in an equipped room, after all aseptic measures. A 20 gauge intravenous cannula was inserted for maintaining a peripheral line and 0.9% normal saline was used for loading the patient. The pulse and blood pressure were monitored non-invasively. The median approach was utilized and intrathecal space was accessed via 25 gauge Quiincke bevel(Becton Dickinson/Pakistan ) through L4-L5. A block was performed by using 5 mg hyperbaric bupivacaine (Abocain 0.5%/Abbot) after ensuring swirling. Block height was monitored via pinprick test after every three minutes, for 20 minutes until there was no progression. The couple was left alone. The couples received prior training and were explained precautions.</description>
    <arm_group_label>post intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Virgin married women with non-consummation of marriage for more than two years due to&#xD;
             vaginismus&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  partners reported erectile dysfunction&#xD;
&#xD;
          -  who had vulvar skin conditions (e.g. lichen sclerosus)&#xD;
&#xD;
          -  vulvovaginal and urinary tract infections&#xD;
&#xD;
          -  endometriosis.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 17, 2020</study_first_posted>
  <last_update_submitted>June 30, 2020</last_update_submitted>
  <last_update_submitted_qc>June 30, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karachi Medical and Dental College</investigator_affiliation>
    <investigator_full_name>samia husain</investigator_full_name>
    <investigator_title>clinical investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vaginismus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</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/NCT04436172
org study id: KarchiMDC
nct id: NCT04436172
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Painful sex continues to be a relationship issue and can lead to marital dys-harmony. Other
      consequences include infertility, low self-esteem, depression and anxiety.Our study shows
      that spinal anesthesia is an effective last resort management option in women with
      vaginismus. As a one-off treatment spinal anesthesia provides hope for such couples and
      brings about a positive change in their relationships.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: successful sexual intercourse
time frame: 1 year
description: whether couple was able to have sexual intercourse after treatment
measure: improvement in Female sexual functioning index
time frame: 1 year
description: Female sexual function index (FSFI) questionnaire consists of 19 questions that assess 6 domains to assess sexual feelings and responses during the past 4 weeks.
measure: depression and relationship satisfaction
time frame: 1 year
description: Depression was assessed by Zung's score. Zung's Self-Rating Depression Scale is a twenty item likert scale with raw score that ranges from 20 to 80. There are 20 items on the scale that rate the four common characteristics of depression: the pervasive effect, the physiological equivalents, other disturbances, and psychomotor activities.
Relationaship assessment was assesed by relationship assessment score.The Relationship Assessment Scale (RAS) is a brief measure of global relationship satisfaction.
arm group label: pre intervention
arm group type: No Intervention
description: Before intervention
arm group label: post intervention
arm group type: Experimental
description: Received soinal anesthesia
intervention type: Procedure
intervention name: spinal anesthesia
description: The spinal anesthesia was given by a trained anesthetist in an equipped room, after all aseptic measures. A 20 gauge intravenous cannula was inserted for maintaining a peripheral line and 0.9% normal saline was used for loading the patient. The pulse and blood pressure were monitored non-invasively. The median approach was utilized and intrathecal space was accessed via 25 gauge Quiincke bevel(Becton Dickinson/Pakistan ) through L4-L5. A block was performed by using 5 mg hyperbaric bupivacaine (Abocain 0.5%/Abbot) after ensuring swirling. Block height was monitored via pinprick test after every three minutes, for 20 minutes until there was no progression. The couple was left alone. The couples received prior training and were explained precautions.
arm group label: post intervention
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Karachi Medical and Dental College
investigator full name: samia husain
investigator title: clinical investigator
mesh term: Vaginismus
mesh term: Anesthetics
sharing ipd: No