Spinal Anesthesia Facilitated Sexual Intercourse As A Treatment Option For Vaginismus
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2017
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2017
CompletedFirst Submitted
Initial submission to the registry
June 15, 2020
CompletedFirst Posted
Study publicly available on registry
June 17, 2020
CompletedJuly 2, 2020
June 1, 2020
12 months
June 15, 2020
June 30, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
successful sexual intercourse
whether couple was able to have sexual intercourse after treatment
1 year
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 Outcomes (1)
depression and relationship satisfaction
1 year
Study Arms (2)
pre intervention
NO INTERVENTIONBefore intervention
post intervention
EXPERIMENTALReceived soinal anesthesia
Interventions
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.
Eligibility Criteria
You may qualify if:
- Virgin married women with non-consummation of marriage for more than two years due to vaginismus
You may not qualify if:
- partners reported erectile dysfunction
- who had vulvar skin conditions (e.g. lichen sclerosus)
- vulvovaginal and urinary tract infections
- endometriosis.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karachi Medical and Dental Collegelead
- Aziz Medical Centercollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- clinical investigator
Study Record Dates
First Submitted
June 15, 2020
First Posted
June 17, 2020
Study Start
January 1, 2017
Primary Completion
December 31, 2017
Study Completion
December 31, 2017
Last Updated
July 2, 2020
Record last verified: 2020-06
Data Sharing
- IPD Sharing
- Will not share