Clinical trial NCT00417365: Efficacy of (WaterWorks®)Douching Device for Elimination of Perceived Vaginal Odor Not Caused by BV or Vaginitis
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"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vaginal Odor
Keywords: odor
douching
BV
vaginitis
vaginal
yeast
ecosystem
Lactobacilli
Nugent
Amsel
Lead sponsor: Abbott Research Group
Sponsor class: INDUSTRY
First posted: 2007-01-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: The primary endpoint of the study is the reduction or abatement of the
measure: subject's perceived vaginal odor as determined at Visit 3.
measure: This improvement will be measured using a visual analog scale that
measure: asks subjects to rate their perception of vaginal odor on a scale that
measure: is anchored at two extremes, "no odor", and, "strong offensive odor".
Secondary outcomes:
measure: Effects on the vaginal Eco-System will be assessed using the
measure: Lactobacilli score and the Nugent score. The safety profile of the douching
measure: device (Water Works® versus control) will be assessed through the collection
measure: of any reported adverse events. Any adverse event, will be reported in terms
measure: of severity, relationship to treatment, duration, and resolution.
Other outcomes:
Locations:
city: Aventura
country: United States
facility: Segal Institute of Clinical Research
state: Florida
city: Plantation
country: United States
facility: Discovery Research, Inc.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Women's Research Institute
state: Georgia
city: Detroit
country: United States
facility: Wayne State University, Harper Hospital
state: Michigan
city: Winston Salem
country: United States
facility: Salem Research
state: North Carolina
city: Tulsa
country: United States
facility: University of Oklahoma
state: Oklahoma
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
Study officials:
affiliation: Temple University
name: Ashwin Chatwani, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Wayne State University
name: Jack Sobel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Infectious Diseases in Obstetrics and Gynecology Volume 2006 (2006), Article ID 95618, 4 pages doi:10.1155/IDOG/2006/95618 /Published results are from ARG sponsored study ARG105.
citation: Hassan S, Chatwani A, Brovender H, Zane R, Valaoras T, Sobel JD. Douching for perceived vaginal odor with no infectious cause of vaginitis: a randomized controlled trial. J Low Genit Tract Dis. 2011 Apr;15(2):128-33. doi: 10.1097/LGT.0b013e3181fb4270.