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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04436172
Other study ID # KarchiMDC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
See also
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