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Clitoral Therapy Device in Alleviating Sexual Dysfunction After Genital Mutilation.

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05039775
Enrollment
80
Registered
2021-09-10
Start date
2021-09-30
Completion date
2022-01-31
Last updated
2022-01-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sexual Arousal Disorder, Sexual Dysfunction

Keywords

Sexual arousal disorder

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.

Interventions

DEVICEEROS 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.

BEHAVIORALPsychosexual 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.

Sponsors

Badr University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
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.

Countries

Egypt

Contacts

Primary ContactHEND SAKR, PhD
hend.reda@buc.edu.eg+201010151300
Backup ContactMariam El-Ebrashy, PhD
dr_mariam_elebrashy@yahoo.com+201001716570

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026