Clitoral Therapy Device in Alleviating Sexual Dysfunction After Genital Mutilation.

Sexual Dysfunction Clinical Trial

Official title:

Clitoral Therapy Device in Alleviating Sexual Dysfunction After Genital Mutilation of Females in Egypt.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05039775
• Other study ID #: Hend3
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: January 2022

Study information

• Verified date: January 2022
• Source: Badr University
• Contact: HEND SAKR, PhD
• Phone: +201010151300
• Email: hend.reda[@]buc.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The aim of this study to determine the effect of clitoral therapy device EROS device/ on sexual dysfunction after genital mutilation.

Description:

Little attention has been given to women who exposed to genital mutilation surgery in early age in the middle east. Most of them suffer from sexual dysfunction of sexual arousal and orgasm when they get in an intimate relation with their husbands after marriage. Clitoral therapy device may improve sexual arousal and alleviate sexual dysfunction symptoms to a great extent.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

• All are suffering sexual dysfunction of sexual arousal and all referred from the family planning and reproductive health department, National research Center.

Exclusion Criteria:

• Metastatic disease, severe bowel or bladder sequelae, and significant comorbidities. Women with a history of sexual trauma or abuse, or undergoing current antidepressant therapy were excluded.

Related Conditions & MeSH terms

• Sexual Arousal Disorder
• Sexual Dysfunction
• Sexual Dysfunctions, Psychological

Intervention

Device:
• EROS device
Eros is a small, hand-held device fitted with a removable, replaceable small plastic cup used as a natural way to initiate female sexual response. It was originally cleared by the FDA in April 2000 for the treatment of Female Sexual Arousal Disorder (FSAD), which includes problems with sexual arousal and orgasm.

Behavioral:
• Psychosexual support
Strategies are suggested to improve the couple's emotional connection and communication, when couples are being consulted, they are encouraged to focus on the strengths as well as weaknesses in their relationship. Homework assignments are given for the couple to practice skills, such as turning the idea of sexual obligation into pleasure, learning to focus on sensations rather than anxieties and communicating openly with their partner.

Locations

Country	Name	City	State
Egypt	Badr University in Cairo	New Cairo	Badr City

Sponsors (1)

Lead Sponsor	Collaborator
Badr University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Female Sexual Function Index (FSFI).	Female sexual dysfunction has traditionally included disorders of desire. libido, arousal, pain/discomfort, and inhibited orgasm.	Change from baseline sexual function at 3 months.