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VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia

VIBRENT- VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia

Who can join

Ages 18 and older · Women

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

About the study

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 vaginal dilators. * Use the assigned device three times per week for 15 minutes per session over four weeks. * Complete surveys before and after the study, including assessments of sexual function, pain, and overall improvement.

What is being tested

• Pelvic floor therapy (device)

Sponsor: Medstar Health Research Institute · Participants: 60 · Started: Mar 1, 2025

Contact the study team

• Helen Y Zhang, MD · Phone: 202-877-6526
• Eun Sook Choi, MD · Phone: 202-877-6526

Official record on ClinicalTrials.gov — NCT06840314

Locations in the U.S.

Conditions

• Sexual Problems in Women
• Pelvic Pain
• Vulvodynia

From ClinicalTrials.gov, data retrieved Oct 2, 2026. Each study sets its own eligibility; the study team decides who can join.