Efficacy of (WaterWorks®)Douching Device for Elimination of Perceived Vaginal Odor Not Caused by BV or Vaginitis

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.

Inclusion Criteria:

Enrollment in the study will be open to those subjects who meet the following inclusion
criteria:

1. Non-pregnant females, 18 years and older

2. Complaint of abnormal vaginal odor with or without complaints of discharge

3. Subject with perceived, abnormal vaginal odor on the date she is evaluated

4. 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

5. Subject is not fulfilling Amsel's criteria for BV listed below (only meets 0 or 1
Amsel's criteria)

6. Not treated for Bacterial Vaginosis, VVC, intra-vaginal or oral anti-fungal
medications or antibiotics, within the last 14 days of enrollment

7. Willing and able to comply with study requirements

8. Has provided written informed consent

Exclusion Criteria:

Subjects will be excluded from the enrollment if they have any of the following:

1. Odor scale less than 4 cm (on the Visual Analog rating scale of 10 cm)

2. Subjects with presence of BV

3. Subjects with other lower genital tract infections (e.g., symptomatic VVC,
trichomoniasis, Chlamydia trachomatis, Neisseria gonorrhoeae or herpes simplex virus)

4. Subjects with another vaginal or vulvar condition, which would confound the
interpretation of clinical response

5. Subjects who received antifungal or antimicrobial therapy (systemic or intravaginal)
within the last 14 days

6. Subjects who will be under treatment during the study period for cervical
intra-epithelial neoplasia (CIN) or cervical carcinoma

7. Positive pregnancy test

8. Any abnormal anatomy or pathology of the subject's vagina

9. Known HIV positive

10. Pap smear >LSIL (untreated or not evaluated) [LSIL = Low-grade squamous
intraepithelial lesion]

11. Subject currently having a menstrual period (excluded until completion of period)

12. Subjects with a body mass index (BMI) of 39 or greater

13. Investigator believes that external factor(s) is producing odor