Spinal Anesthesia Facilitated Sexual Intercourse As A Treatment Option For Vaginismus

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.

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Key information

Conditions

Vaginismus Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases Vaginal Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Spinal anesthesia

Procedure

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 outcomes

successful sexual intercourse

Time frame: 1 year

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

Time frame: 1 year

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 outcomes

depression and relationship satisfaction

Time frame: 1 year

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.

Sponsors and collaborators

Lead sponsor

Karachi Medical and Dental College

Other

Collaborators

Aziz Medical Center

Registry information

Official study 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

Important dates

Study start: 2017
Primary completion: 2017
Study completion: 2017
First posted: Jun 17, 2020
Registry last updated: Jul 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed