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Clitoral Therapy Device in Alleviating Sexual Dysfunction After Genital Mutilation.

Sponsor
Badr University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05039775
Collaborator
(none)
80
Enrollment
1
Location
2
Arms
3.1
Anticipated Duration (Months)
26.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: EROS device
  • Behavioral: Psychosexual support
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Clitoral Therapy Device in Alleviating Sexual Dysfunction After Genital Mutilation of Females in Egypt.
Actual Study Start Date :
Sep 30, 2021
Anticipated Primary Completion Date :
Jan 1, 2022
Anticipated Study Completion Date :
Jan 1, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Badr University in Cairo New Cairo Badr City Egypt 11829

    Sponsors and Collaborators

    • Badr University

    Investigators

    • Principal Investigator: Amr Abbassy, PhD, National Research Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hend Reda Sakr, Lecturer of Physical Therapy for Woman's Health, Badr University
    ClinicalTrials.gov Identifier:
    NCT05039775
    Other Study ID Numbers:
    • Hend3
    First Posted:
    Sep 10, 2021
    Last Update Posted:
    Jan 19, 2022
    Last Verified:
    Jan 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Keywords provided by Hend Reda Sakr, Lecturer of Physical Therapy for Woman's Health, Badr University
    Sexual arousal disorder
    Additional relevant MeSH terms:
    Sexual Dysfunctions, Psychological

    Study Results

    No Results Posted as of Jan 19, 2022