VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia

Launched by MEDSTAR HEALTH RESEARCH INSTITUTE · Feb 17, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new vibrating device called the "Kiwi" to see if it can help improve sexual function in women who have pain during sex, a condition known as genito-pelvic pain/penetration disorder (GPPPD). The researchers want to find out if using the Kiwi device is more effective than using traditional vaginal dilators, which are cylindrical tools designed to help with this issue. Women aged 18 and older who experience pain during sexual activities may be eligible to participate.

Participants will be randomly assigned to use either the Kiwi device or a traditional dilator for 15 minutes, three times a week over four weeks. Before and after the study, they will fill out surveys to assess changes in their sexual function, pain levels, and overall improvement. This study is currently looking for women who meet specific criteria, such as being assigned female at birth and having a diagnosed condition like vaginismus or dyspareunia. The goal is to see which method provides better relief from pain and improves sexual experiences.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • Assigned female at birth
• • Age ≥ 18 years old
• • Genito-pelvic pain/penetration disorder (per ICD-10 diagnosis codes: F52.5 Vaginismus not due to a substance or known physiological condition, F52.6 Dyspareunia not due to a substance or known physiological condition, N94.1 Dyspareunia, N94.2 Vaginismus, N94.81 Vulvodynia)
• Exclusion Criteria:
• • Current or prior use of a therapeutic vaginal device used to treat GPPPD
• • Unmanaged genitourinary syndrome of menopause
• • History of pelvic radiation
• • History of genital tract malignancy
• • History of female genital mutilation
• • History of prior surgery for prolapse or incontinence, including vaginal mesh or midurethral sling mesh
• • Silicone allergy