Back to resultsClitoral Therapy Device in Alleviating Sexual Dysfunction After Genital Mutilation.
Primary Purpose
Sexual Dysfunction, Sexual Arousal Disorder
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
EROS device
Psychosexual support
Sponsored by
About this trial
This is an interventional treatment trial for Sexual Dysfunction focused on measuring Sexual arousal disorder
Eligibility Criteria
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.
Sites / Locations
- Badr University in CairoRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Study group
Control group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The Female Sexual Function Index (FSFI).
Female sexual dysfunction has traditionally included disorders of desire. libido, arousal, pain/discomfort, and inhibited orgasm.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05039775
Brief Title
Clitoral Therapy Device in Alleviating Sexual Dysfunction After Genital Mutilation.
Official Title
Clitoral Therapy Device in Alleviating Sexual Dysfunction After Genital Mutilation of Females in Egypt.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 30, 2021 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
January 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Badr University
4. Oversight
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
Data Monitoring Committee
Yes
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sexual Dysfunction, Sexual Arousal Disorder
Keywords
Sexual arousal disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Study group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
EROS device
Other Intervention Name(s)
Clitoral therapy device
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Psychosexual support
Other Intervention Name(s)
Psychosexual therapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
The Female Sexual Function Index (FSFI).
Description
Female sexual dysfunction has traditionally included disorders of desire. libido, arousal, pain/discomfort, and inhibited orgasm.
Time Frame
Change from baseline sexual function at 3 months.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
This study is targeting females who subjected to genital mutilation affecting their sexual life after marriage.
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
HEND SAKR, PhD
Phone
+201010151300
Email
hend.reda@buc.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Mariam El-Ebrashy, PhD
Phone
+201001716570
Email
dr_mariam_elebrashy@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amr Abbassy, PhD
Organizational Affiliation
National Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Badr University in Cairo
City
New Cairo
State/Province
Badr City
ZIP/Postal Code
11829
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hend Sakr, PhD
Phone
+201010151300
Email
hend.reda@buc.edu.eg
First Name & Middle Initial & Last Name & Degree
Amr Abbassy, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clitoral Therapy Device in Alleviating Sexual Dysfunction After Genital Mutilation.
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