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VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia

RecruitingNAAges 18 Years - anyFemaleMedstar Health Research Institute
NCT06840314 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

The goal of this randomized controlled trial is to determine whether the use of a novel vibrating pelvic floor therapeutic device ("Kiwi") improves sexual function in sexually active women aged 18 and older with genito-pelvic pain and penetration disorder (GPPPD) more effectively than traditional vaginal dilators. The main questions it aims to answer are: 1. Does the use of the Kiwi device lead to higher sexual function scores compared to traditional vaginal dilators 2. Does the Kiwi device improve sexual distress, pain, and overall symptom severity more effectively than traditional vaginal dilators? Researchers will compare the Kiwi vibrating device to traditional cylindrical vaginal dilators to assess whether the Kiwi device results in greater improvements in sexual function and symptom relief. Participants will: * Be randomly assigned to use either the Kiwi device or traditional

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📋 Eligibility rules (as published)
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
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What it tests

  • Pelvic floor therapy
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Where

1 site
MedStar Health
Washington D.C., United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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