Prospective on Market Patient-reported Outcomes for Milli
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Penetration Efficiency Questionnaire
研究概览
简要总结
To assess the effectiveness of the Milli device in achieving vaginal intercourse
详细描述
The Milli Vaginal Dilator is a patient-controlled vaginal dilator that provides therapy through distention of the vaginal tissue under electromechanical expansion.
This study is intended to provide data in support of the Milli Vaginal Dilator as a commercially available, over-the-counter medical device.
The Milli has been granted marketing authorization by the FDA under premarket notification K220035 for the following Indications for Use statement:
The Milli Vaginal Dilator is a tool indicated for controlled dilation of the vagina. It can be used for dilation for an examination (by your doctor), in preparation for a surgical procedure, or to help relieve the symptoms of vaginismus (condition that involves tightening of the vaginal muscles) and related painful sex.
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研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Subject is a female at birth aged ≥18 years of age
- •Subject is able to read and understand the approved, informed consent form (ICF)
- •Subject meets vaginismus and related painful sex/GPPPD criteria as defined in the DSM-5, as confirmed by having one or more of the following for greater than 6 months:
- •Pelvic pain
- •Vaginal pain
- •Pain with vaginal intercourse
- •Pain with vaginal penetration
- •Fear or anxiety about vaginal or pelvic pain with vaginal penetration
- •The inability to achieve vaginal penetration
- •Subject currently has a sexual partner with a functional penis
- •Subject is currently seeking vaginal penetration to achieve sexual intercourse
- •Subject is currently unable to tolerate vaginal penetration to achieve sexual intercourse (Score of ≤1 on PEQ Question #1)
- •Subject purchased Milli vaginal dilator
- •Subject is not contraindicated for Milli vaginal dilator use
- •Subject is able and willing to comply with study protocol
排除标准
- •Subject has previously participated in any studies by the company in the past 12 months or has used Milli prior to enrollment
- •Subject is pregnant
- •Subject has an active pelvic infection (vagina or vulva)
- •Subject has open wounds in the tissue inside or surrounding the vagina
- •Subject has an untreated major mental health disorder (e.g., affective disorder, psychosis, PTSD)
- •Subject has prior history of gender-confirming surgery, vaginal reconstruction surgery, pelvic radiation, and/or vaginal procedures that result in extensive scarring (with the exception of hysterectomy procedures)
- •Subject or subject's partner experiences other conditions preventing intercourse (e.g., erectile dysfunction, lack of libido)
结局指标
主要结局
Penetration Efficiency Questionnaire
时间窗: 6 months
Ability to achieve full vaginal penetration with the penis of the partner (intercourse) as measured by the Penetration Efficiency Questionnaire (Score of ≥2 on PEQ Question #1) at six months
次要结局
- Penetration Efficiency Questionnaire(3 months, 6 months)
- Female Sexual Function Index (FSFI)(3 months, 6 months)
- Numerical Rating Scale(3 months, 6 months)