Actively Recruiting
VIBRENT- 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
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a new vibrating pelvic floor device called the Kiwi improves sexual function better than traditional vaginal dilators in sexually active women aged 18 and older with genito-pelvic pain and penetration disorder (GPPPD). This randomized controlled trial aims to compare improvements in sexual function, distress, pain, and overall symptom severity between the two treatments. Participants will be randomly assigned to use either the Kiwi device or a standard set of graduated silicone vaginal dilators. They will use their assigned device three times a week for 15 minutes per session over four weeks. The Kiwi device offers vibration and multiple massage options, while traditional dilators provide progressive sizing without vibration. During the study, participants will complete surveys before and after the four-week period to assess sexual function, pain levels, distress, and symptom improvement using validated questionnaires. The main measure is the Female Sexual Function Index (FSFI) score after four weeks. This study lasts four weeks, with data collected at the start and end to evaluate treatment effects.
CONDITIONS
Brief 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 and penetration disorder as defined by specific ICD-10 codes (including vaginismus, dyspareunia, vulvodynia)
You will not qualify if you...
- Current or prior use of therapeutic vaginal devices for genito-pelvic pain and penetration disorder
- Unmanaged genitourinary syndrome of menopause
- History of pelvic radiation
- History of genital tract cancer
- History of female genital mutilation
- Prior surgery for prolapse or incontinence, including vaginal mesh or midurethral sling mesh
- Allergy to silicone
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 4 weeks
Participants use either a vibrating pelvic floor therapeutic device or traditional vaginal dilators three times per week for 15 minutes per session over four weeks.
Baseline visit and 1 follow-up visit at 4 weeks
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
E
Eun Sook Choi, MD
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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