Evaluation of a Postcoital Sponge on Self-Reported Vaginal Health Parameters
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 1,000
- 试验地点
- 2
- 主要终点
- User Experience Questionnaire
研究概览
简要总结
LiviWell has developed a product designed for postcoital semen absorption. Previous studies have demonstrated the product rapidly absorbs semen, and leads to less symptoms of postcoital vaginal microbiome disruption such as vaginal odor and discharge. This study will investigate the study device, Livi, in a broader clinical setting.
详细描述
LiviWell's consumer hygiene device is a post-coital vaginal insert called "Livi". Livi is comprised of an applicator, with a medical-grade polyurethane foam and retrieval string. It is designed to be inserted into the vagina after intercourse to absorb semen deposited into the vaginal canal. The result is a decrease in discharge/dripping and vaginal odor. The investigators also believe the device will lower vaginal pH, as the typical premenopausal vaginal pH is acidic (pH ~4), and semen has an alkaline pH (~8). The resulting pH imbalance in sexually-active women not using male condoms had been shown to lead to vaginal odor, dripping, discomfort. Furthermore, the risk of bacterial vaginosis (BV) is higher in women who are sexually active and not using male condoms. The investigators have additional studies planned to evaluate if the product lowers the risk of BV.
The current study will be used to validate user needs requirements for the study device, understand pH changes after insertion, and evaluate change in symptoms of vaginal odor, discharge/dripping, and discomfort, common symptoms of vaginal microbiome disruption and bacterial vaginosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 是
入选标准
- •Over 18 (for pH subset, 18-45)
- •Sexually-active with biological men
- •Willing and able to use product
- •Resides in continental USA
- •Understands, reads, writes, and speaks English
排除标准
- •Currently Pregnant or are trying to conceive
- •Unable to use device due to poor motor function
- •Unable to sign informed consent
结局指标
主要结局
User Experience Questionnaire
时间窗: 24 hours
Validation of User Needs Requirements as well as patient experience
次要结局
- change in vaginal pH(2-6 hours, and 10-14 hours after use)
研究者
Michael Ingber
Attending Physician
Atlantic Health System
