Clitoral Therapy Device in Alleviating Sexual Dysfunction After Genital Mutilation.

Not Applicable

• Conditions: Sexual Arousal Disorder; Sexual Dysfunction
• Interventions: Device: EROS device; Behavioral: Psychosexual support

• Registration Number: NCT05039775
• Lead Sponsor: Badr University

Brief Summary

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

Detailed 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.

Study Timeline

• Study First Submitted: 2021-09-01
• Study First Submitted QC: 2021-09-06
• Study First Posted: 2021-09-10
• Study Start: 2021-09-30
• Status Verified: 2022-01
• Primary Completion: 2022-01
• Study Completion: 2022-01
• Last Update Submitted: 2022-01-04
• Last Update Posted: 2022-01-19

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 80

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Study group	EROS device	Forty married women, their ages will range from 20 to 45 years and all are suffering sexual dysfunction of sexual arousal and will use EROS-CTD Clitoral Therapy Device in addition to psychosexual support sessions and will be closely followed for three months.
Study group	Psychosexual support	Forty married women, their ages will range from 20 to 45 years and all are suffering sexual dysfunction of sexual arousal and will use EROS-CTD Clitoral Therapy Device in addition to psychosexual support sessions and will be closely followed for three months.
Control group	Psychosexual support	Forty married women, their ages will range from 20 to 45 years and all are suffering sexual dysfunction of sexual arousal will receive psychosexual support sessions and will be closely followed after 3 months.

Primary Outcome Measures

Name	Time	Method
The Female Sexual Function Index (FSFI).	Change from baseline sexual function at 3 months.	Female sexual dysfunction has traditionally included disorders of desire. libido, arousal, pain/discomfort, and inhibited orgasm.

Trial Locations

Locations (1)

Badr University in Cairo; 🇪🇬 New Cairo, Badr City, Egypt