Efficacy of (WaterWorks®)Douching Device for Elimination of Perceived Vaginal Odor Not Caused by BV or Vaginitis
NCT ID: NCT00417365
Last Updated: 2007-08-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
100 participants
INTERVENTIONAL
2006-08-31
2007-09-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Interventions
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WaterWorks Douching Device
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
FEMALE
No
Sponsors
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Abbott Research Group
INDUSTRY
Principal Investigators
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Ashwin Chatwani, M.D.
Role: PRINCIPAL_INVESTIGATOR
Temple University
Jack Sobel, M.D.
Role: PRINCIPAL_INVESTIGATOR
Wayne State University
Locations
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Segal Institute of Clinical Research
Aventura, Florida, United States
Discovery Research, Inc.
Plantation, Florida, United States
Atlanta Women's Research Institute
Atlanta, Georgia, United States
Wayne State University, Harper Hospital
Detroit, Michigan, United States
Salem Research
Winston-Salem, North Carolina, United States
University of Oklahoma
Tulsa, Oklahoma, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
Countries
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Facility Contacts
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References
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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.
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.
Other Identifiers
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Pre-IDE I060071
Identifier Type: -
Identifier Source: secondary_id
ARG105B
Identifier Type: -
Identifier Source: org_study_id