Clitoral Therapy Device in Alleviating Sexual Dysfunction After Genital Mutilation.

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

Detailed Description
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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.

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

Conditions
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Sexual Dysfunction, Sexual Arousal Disorder

Intervention / Treatment
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* Device: EROS device
* Behavioral: Psychosexual support


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>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. | Device: EROS device<br>* 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.<br>* Other names: Clitoral therapy device;Behavioral: Psychosexual support<br>* 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.<br>* Other names: Psychosexual therapy;|
| Other: Control group<br>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. | Behavioral: Psychosexual support<br>* 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.<br>* Other names: Psychosexual therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sexual arousal disorder