Comparing a vibrating pelvic floor device to traditional vaginal dilators for treating entry dyspareunia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.