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
About this trial
This is an interventional treatment trial for Vaginismus
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.
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
NCT ID
NCT04436172
First Posted
June 15, 2020
Last Updated
June 30, 2020
Sponsor
Karachi Medical and Dental College
Collaborators
Aziz Medical Center
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
Learn more about this trial
Spinal Anesthesia Facilitated Sexual Intercourse As A Treatment Option For Vaginismus
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