Comparing a vibrating pelvic floor device to traditional vaginal dilators for treating entry dyspareunia
VIBRENT- VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia
This study is testing whether a new vibrating pelvic floor device can help women with pain during sex feel better compared to using traditional vaginal dilators.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Medstar Health Research Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Washington D.C., District of Columbia) |
| Trial ID | NCT06840314 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial evaluates the effectiveness of a novel vibrating pelvic floor therapeutic device, known as the 'Kiwi', in improving sexual function in sexually active women aged 18 and older with genito-pelvic pain and penetration disorder (GPPPD). Participants will be randomly assigned to use either the Kiwi device or traditional vaginal dilators three times a week for 15 minutes over four weeks. The study aims to determine if the Kiwi device leads to higher sexual function scores and greater improvements in sexual distress, pain, and overall symptom severity compared to traditional methods. Data will be collected using validated questionnaires at baseline and after the intervention period.
Who should consider this trial
Good fit: Ideal candidates are women aged 18 and older who have been diagnosed with genito-pelvic pain/penetration disorder.
Not a fit: Patients with unmanaged genitourinary syndrome of menopause or a history of pelvic radiation or genital tract malignancy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for women suffering from genito-pelvic pain and penetration disorders.
How similar studies have performed: While the use of vibrating devices for pelvic therapy is emerging, this specific approach comparing the Kiwi device to traditional dilators is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Washington D.C., District of Columbia
- MedStar Health — Washington D.C., District of Columbia, United States (Recruiting)
Study contacts
- Principal investigator: Cheryl Iglesia, MD — Medstar Washington Hospital Center National Center for Advanced Pelvic Surgery
- Study coordinator: Helen Y Zhang, MD
- Email: helen.y.zhang@medstar.net
- Phone: 202-877-6526
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.