Spinal Anesthesia Facilitated Sexual Intercourse As A Treatment Option For Vaginismus

Vaginismus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04436172
• Other study ID #: KarchiMDC
• Status: Completed
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 31, 2017

Study information

• Verified date: June 2020
• Source: Karachi Medical and Dental College
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 31, 2017
• Est. primary completion date: December 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Vaginismus

Intervention

Procedure:
• spinal anesthesia
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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Karachi Medical and Dental College	Aziz Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	successful sexual intercourse	whether couple was able to have sexual intercourse after treatment	1 year
Primary	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.	1 year
Secondary	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.	1 year