NCT05039775

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 1, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 10, 2021

Completed
20 days until next milestone

Study Start

First participant enrolled

September 30, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

3 months

First QC Date

September 1, 2021

Last Update Submit

January 4, 2022

Conditions

Sexual DysfunctionSexual Arousal Disorder

Keywords

Sexual arousal disorder

Outcome Measures

Primary Outcomes (1)

  • 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.

Study Arms (2)

Study group

EXPERIMENTAL

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 deviceBehavioral: Psychosexual support

Control group

OTHER

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

Interventions

EROS deviceDEVICE

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.

Also known as: Clitoral therapy device
Study group
Psychosexual supportBEHAVIORAL

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.

Also known as: Psychosexual therapy
Control groupStudy group

Eligibility Criteria

Age20 Years - 45 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study is targeting females who subjected to genital mutilation affecting their sexual life after marriage.
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All are suffering sexual dysfunction of sexual arousal and all referred from the family planning and reproductive health department, National research Center.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Badr University in Cairo

New Cairo, Badr City, 11829, Egypt

RECRUITING

Related Publications (1)

  • Sakr HR, Ahmed YA, Kamel RM, Abdelhady RH, Elkalla RA, Georgui MA, Abd El-Khalek WO, El Ebrashy MH. Clitoral Therapy Device for Alleviating Sexual Dysfunction After Female Genital Mutilation: Randomized Controlled Trial. JMIR Rehabil Assist Technol. 2023 Apr 21;10:e43403. doi: 10.2196/43403.

    PMID: 37083562DERIVED

MeSH Terms

Conditions

Sexual Dysfunction, PhysiologicalSexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Genital DiseasesUrogenital DiseasesMental Disorders

Study Officials

  • Amr Abbassy, PhD

    National Research Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

HEND SAKR, PhD

CONTACT

+201010151300hend.reda@buc.edu.eg

Mariam El-Ebrashy, PhD

CONTACT

+201001716570dr_mariam_elebrashy@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Physical Therapy for Woman's Health

Study Record Dates

First Submitted

September 1, 2021

First Posted

September 10, 2021

Study Start

September 30, 2021

Primary Completion

January 1, 2022

Study Completion

January 1, 2022

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)