VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia

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.

NCT Number	NCT06840314
Lead Sponsor	Medstar Health Research Institute
Conditions	Genito-Pelvic Pain/Penetration Disorder, Dyspareunia, Vaginismus, Pelvic Pain, Vestibulodynia, Vulvodynia (Chronic Vulvar Pain)
Enrollment	60 participants
Start Date	2025-03-01
Primary Completion	2025-11 (estimated)
Study Completion	2026-03 (estimated)
Updated on ClinicalTrials.gov	2025-05-21