NCT06840314 VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia
| NCT ID | NCT06840314 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medstar Health Research Institute |
| Condition | Genito-Pelvic Pain/Penetration Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2025-03-01 |
| Primary Completion | 2025-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2025-03-01 with a primary completion date of 2025-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Cheryl Iglesia, MD
PRINCIPAL INVESTIGATOR
Medstar Washington Hospital Center National Center for Advanced Pelvic Surgery
Frequently Asked Questions
Who can join the NCT06840314 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Genito-Pelvic Pain/Penetration Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06840314 currently recruiting?
Yes, NCT06840314 is actively recruiting participants. Contact the research team at helen.y.zhang@medstar.net for enrollment information.
Where is the NCT06840314 trial being conducted?
This trial is being conducted at Washington D.C., United States.
Who is sponsoring the NCT06840314 clinical trial?
NCT06840314 is sponsored by Medstar Health Research Institute. The principal investigator is Cheryl Iglesia, MD at Medstar Washington Hospital Center National Center for Advanced Pelvic Surgery. The trial plans to enroll 60 participants.