VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia

Официальное название

VIBRENT- VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia

Обзор

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.

Подробное описание

This randomized controlled trial (RCT) aims to evaluate the efficacy of a novel vibrating pelvic floor therapeutic device (the "Kiwi") compared to traditional vaginal dilators in improving sexual function outcomes in sexually active women aged 18 and older with genito-pelvic pain and penetration disorder (GPPPD).

The primary objective is to determine whether the Kiwi device leads to higher Female Sexual Function Index (FSFI) scores after four weeks of use compared to traditional dilators.

Secondary objectives include assessing improvements in:

* Sexual distress (Female Sexual Distress Scale - Desire/Arousal/Orgasm, FSDS-DAO) * Pelvic pain (Vulvar Pain Assessment Questionnaire, VPAQ-screen subscale) * Overall symptom severity (Patient Global Impression of Severity, PGI-S) * Perceived improvement (Patient Global Impression of Improvement, PGI-I)

Participants (n=60) will be randomized into two arms:

1. Kiwi device group - a commercially available vibrating pelvic floor therapeutic product. 2. Traditional dilator group - a standard graduated cylindrical vaginal dilator set.

Participants will use their assigned device three times per week for 15 minutes per session over a four-week period. Data will be collected at baseline and at the end of the study using validated questionnaires.

The study hypothesizes that participants using the Kiwi device will demonstrate greater improvements in FSFI scores compared to those using traditional vaginal dilators, reflecting enhanced sexual function and reduced symptom severity.

Вмешательства

• Устройство Pelvic floor therapy
  Once randomized to either the vibrating pelvic floor massage arm or the traditional vaginal dilator arm, they will receive instructions on frequency of device use and will use manufacturer's instructions for specifics of device use. We will not dictate more specific instructions on use, nor is this standard of care, as every patient is unique and will need to retain autonomy in terms of how quickly they progress in the use of the product. They will then complete a survey at 4 weeks which include

Первичные конечные точки

• Female Sexual Function Index (FSFI) [Срок оценки: Four weeks]

Вторичные конечные точки (5)

• FSDS-DAO (Female Sexual Distress Scale- Distress/Arousal/Orgasm) Questionnaire [Срок оценки: Four weeks]
• Primary Outcome Questionnaire (PEQ) [Срок оценки: Four weeks]
• PGI-S- Patient Global Impression of Severity [Срок оценки: Four weeks]
• Patient Global Impression Of Improvement (PGI-I) [Срок оценки: Four weeks]
• VPAQ-screen Subscale: Self Stimulation/Penetration Interference (Vulvar Pain Assessment Questionnaire- Screening Form) [Срок оценки: Four weeks]

Критерии участия

Критерии включения

• 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)

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• MedStar Health — Washington D.C.

Идентификаторы

NCT: NCT06840314 · STUDY00008357

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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