Actively Recruiting
VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia
Led by Medstar Health Research Institute · Updated on 2025-05-21
60
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Assigned female at birth
- Age 18 years or older
- Diagnosed with genito-pelvic pain/penetration disorder (including vaginismus, dyspareunia, vestibulodynia, vulvodynia) per ICD-10 codes
You will not qualify if you...
- Current or prior use of therapeutic vaginal devices for genito-pelvic pain/penetration disorder
- Unmanaged genitourinary syndrome of menopause
- History of pelvic radiation
- History of genital tract cancer
- History of female genital mutilation
- History of prior surgery for prolapse or incontinence, including vaginal mesh or midurethral sling mesh
- Silicone allergy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MedStar Health
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
Research Team
H
Helen Y Zhang, MD
CONTACT
E
Eun Sook Choi, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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