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

Abbott

Status

Unknown

Conditions

Vaginal Odor

Treatments

Device: WaterWorks Douching Device

Study type

Interventional

Funder types

Industry

Identifiers

NCT00417365

ARG105B

Pre-IDE I060071

Details and patient eligibility

About

Comparing the new Stainless Steel WaterWorks® douching device to a commercially available douching device using just water for safety and efficacy of odor abatement.

Full description

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.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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