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

Abbott Research Group100 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

100

Conditions

Vaginal Odor

Interventions

WaterWorks Douching DeviceDEVICE

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (7)

Segal Institute of Clinical Research

Aventura, Florida, United States

COMPLETED

Discovery Research, Inc.

Plantation, Florida, United States

WITHDRAWN

Atlanta Women's Research Institute

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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".

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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