Vaginal Odor Clinical Trial
Official title:
"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"
Comparing the new Stainless Steel WaterWorks® douching device to a commercially available douching device using just water for safety and efficacy of odor abatement.
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.
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment