Clitoral Therapy Device in Alleviating Sexual Dysfunction After Genital Mutilation.

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

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

Study Overview

• Status: Recruiting
• Conditions: Sexual Dysfunction; Sexual Arousal Disorder
• Intervention / Treatment: Device: EROS device; Behavioral: Psychosexual support

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 Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hend Sakr, PhD; Phone Number: +201010151300; Email: hend.reda@buc.edu.eg
• Study Contact Backup: Name: Mariam El-Ebrashy, PhD; Phone Number: +201001716570; Email: dr_mariam_elebrashy@yahoo.com

Study Locations

• Egypt
  • Badr City
    • New Cairo, Badr City, Egypt, 11829
      • Recruiting
      • Badr university in Cairo
      • Contact: Hend Sakr, PhD; Phone Number: +201010151300; Email: hend.reda@buc.edu.eg
      • Sub-Investigator: Amr Abbassy, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Study group; 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; 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.; Other Names: Clitoral therapy device; 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.; Other Names: Psychosexual therapy
OTHER: Control group; 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; 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.; Other Names: Psychosexual therapy

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Badr University
• Investigators: Principal Investigator: Amr Abbassy, PhD, National research center

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 30, 2021
• Primary Completion (ANTICIPATED): January 1, 2022
• Study Completion (ANTICIPATED): January 1, 2022

Study Registration Dates

• First Submitted: September 1, 2021
• First Submitted That Met QC Criteria: September 6, 2021
• First Posted (ACTUAL): September 10, 2021

Study Record Updates

• Last Update Posted (ACTUAL): January 19, 2022
• Last Update Submitted That Met QC Criteria: January 4, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Sexual arousal disorder
• Additional Relevant MeSH Terms: Mental Disorders; Sexual Dysfunctions, Psychological
• Other Study ID Numbers: Hend3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes