VIBRENT- VIBRating vs Traditional Therapy for Treatment of ENTry Dyspareunia
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Female Sexual Function Index (FSFI)
研究概览
简要总结
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:
- Does the use of the Kiwi device lead to higher sexual function scores compared to traditional vaginal dilators
- 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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Female Sexual Function Index (FSFI)
时间窗: Four weeks
FSFI is considered the gold standard for the measurement of sexual function in women. It's a 19-item questionnaire that uses a 5 point Likert scale ranging from 1-5, with higher scores indicating greater levels of sexual functioning on the respective item. To score the measure, the sum of each domain score is multipled by a domain factor ratio (0.6 for desire, 0.3 for arousal, 0.3 for lubrication, 0.4 for orgasm, 0.4 for satisfaction, and 0.4 for pain) in order to place all domain tools on a comparable scale. The subsequent scores are summed to derive a total FSFI score. The possible range of scores is 2-36. A score less than or equal to 26.55 reflects clinically relevant sexual dysfunction.
次要结局
- Patient Global Impression Of Improvement (PGI-I)(Four weeks)
- FSDS-DAO (Female Sexual Distress Scale- Distress/Arousal/Orgasm) Questionnaire(Four weeks)
- PGI-S- Patient Global Impression of Severity(Four weeks)
- Primary Outcome Questionnaire (PEQ)(Four weeks)
- VPAQ-screen Subscale: Self Stimulation/Penetration Interference (Vulvar Pain Assessment Questionnaire- Screening Form)(Four weeks)