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Spinal Anesthesia Facilitated Sexual Intercourse As A Treatment Option For Vaginismus

Primary Purpose

Vaginismus

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
spinal anesthesia
Sponsored by
Karachi Medical and Dental College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginismus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Virgin married women with non-consummation of marriage for more than two years due to vaginismus

Exclusion Criteria:

  • partners reported erectile dysfunction
  • who had vulvar skin conditions (e.g. lichen sclerosus)
  • vulvovaginal and urinary tract infections
  • endometriosis.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Experimental

    Arm Label

    pre intervention

    post intervention

    Arm Description

    Before intervention

    Received soinal anesthesia

    Outcomes

    Primary Outcome Measures

    successful sexual intercourse
    whether couple was able to have sexual intercourse after treatment
    improvement in Female sexual functioning index
    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.

    Secondary Outcome Measures

    depression and relationship satisfaction
    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.

    Full Information

    First Posted
    June 15, 2020
    Last Updated
    June 30, 2020
    Sponsor
    Karachi Medical and Dental College
    Collaborators
    Aziz Medical Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04436172
    Brief Title
    Spinal Anesthesia Facilitated Sexual Intercourse As A Treatment Option For Vaginismus
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    January 1, 2017 (Actual)
    Primary Completion Date
    December 31, 2017 (Actual)
    Study Completion Date
    December 31, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Karachi Medical and Dental College
    Collaborators
    Aziz Medical Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Vaginismus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    pre intervention
    Arm Type
    No Intervention
    Arm Description
    Before intervention
    Arm Title
    post intervention
    Arm Type
    Experimental
    Arm Description
    Received soinal anesthesia
    Intervention Type
    Procedure
    Intervention Name(s)
    spinal anesthesia
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    successful sexual intercourse
    Description
    whether couple was able to have sexual intercourse after treatment
    Time Frame
    1 year
    Title
    improvement in Female sexual functioning index
    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.
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    depression and relationship satisfaction
    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.
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Virgin married women with non-consummation of marriage for more than two years due to vaginismus Exclusion Criteria: partners reported erectile dysfunction who had vulvar skin conditions (e.g. lichen sclerosus) vulvovaginal and urinary tract infections endometriosis.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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