"A Comparison Study of the WaterWorks® Douching Device vs. Commercial OTC Douching Device for the Reduction or Abatement of Perceived Vaginal Odor With or Without Complaints of Discharge in Women With no Infectious Causes of Vaginitis"
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 14
- 主要终点
- The primary endpoint of the study is the reduction or abatement of the
研究概览
简要总结
Comparing the new Stainless Steel WaterWorks® douching device to a commercially available douching device using just water for safety and efficacy of odor abatement.
详细描述
Vaginal symptoms, including abnormal odor with or without complaints of discharge, are relatively common complaints. It is generally assumed that most women with these complaints have a vaginal infection, bacterial vaginosis, trichomoniasis, or vulvovaginal candidiasis. However, investigators suggest that there is a large population of women who complain of odor with or without complaints of discharge, and in whom no clear cause can be found. For these women, there are currently no treatment options.
Anecdotal evidence suggests that stainless steel used with just water has an effect in reducing odors and is so used to reduce odors on hands by chefs. The Water Works® Douching Device is a light-weight (1oz) stainless steel douching device that was developed to aid in the treatment of vaginal odor. Additional anecdotal evidence suggests that douching with the Water Works® Douching Device had little or no affect on the vaginal Eco-System (e.g. good bacteria, Lactobacilli).
This study (ARG105B) will compare the Water Works® Douching Device to a commercially available over the counter douching device for the ability to reduce or eliminate abnormal odor (with or without complaints of discharge) in women with this subjective complaint, but no objective findings of a vaginal infection. The study will also compare the Water Works® Douching Device to the commercial device with respect to the adverse effect of the vaginal Eco-System.
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
- Single (Investigator)
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
- •Enrollment in the study will be open to those subjects who meet the following inclusion criteria:
- •Non-pregnant females, 18 years and older
- •Complaint of abnormal vaginal odor with or without complaints of discharge
- •Subject with perceived, abnormal vaginal odor on the date she is evaluated
- •Odor scale 4 cm or greater (using the subject's perception visual analog rating scale of 10 cm): 0 = no odor 10 = strong offensive odor
- •Subject is not fulfilling Amsel's criteria for BV listed below (only meets 0 or 1 Amsel's criteria)
- •Not treated for Bacterial Vaginosis, VVC, intra-vaginal or oral anti-fungal medications or antibiotics, within the last 14 days of enrollment
- •Willing and able to comply with study requirements
- •Has provided written informed consent
排除标准
- •Subjects will be excluded from the enrollment if they have any of the following:
- •Odor scale less than 4 cm (on the Visual Analog rating scale of 10 cm)
- •Subjects with presence of BV
- •Subjects with other lower genital tract infections (e.g., symptomatic VVC, trichomoniasis, Chlamydia trachomatis, Neisseria gonorrhoeae or herpes simplex virus)
- •Subjects with another vaginal or vulvar condition, which would confound the interpretation of clinical response
- •Subjects who received antifungal or antimicrobial therapy (systemic or intravaginal) within the last 14 days
- •Subjects who will be under treatment during the study period for cervical intra-epithelial neoplasia (CIN) or cervical carcinoma
- •Positive pregnancy test
- •Any abnormal anatomy or pathology of the subject's vagina
- •Known HIV positive
- •Pap smear >LSIL (untreated or not evaluated) [LSIL = Low-grade squamous intraepithelial lesion]
- •Subject currently having a menstrual period (excluded until completion of period)
- •Subjects with a body mass index (BMI) of 39 or greater
- •Investigator believes that external factor(s) is producing odor
结局指标
主要结局
The primary endpoint of the study is the reduction or abatement of the
subject's perceived vaginal odor as determined at Visit 3.
This improvement will be measured using a visual analog scale that
asks subjects to rate their perception of vaginal odor on a scale that
is anchored at two extremes, "no odor", and, "strong offensive odor".
次要结局
- Effects on the vaginal Eco-System will be assessed using the
- Lactobacilli score and the Nugent score. The safety profile of the douching
- device (Water Works® versus control) will be assessed through the collection
- of any reported adverse events. Any adverse event, will be reported in terms
- of severity, relationship to treatment, duration, and resolution.