Efficacy of (WaterWorks®)Douching Device for Elimination of Perceived Vaginal Odor Not Caused by BV or Vaginitis
Recruitment status was: Recruiting
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
|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"|
- 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".
- 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.
|Study Start Date:||August 2006|
|Estimated Study Completion Date:||September 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00417365
|United States, Florida|
|Segal Institute of Clinical Research|
|Aventura, Florida, United States, 33161|
|United States, Georgia|
|Atlanta Women's Research Institute|
|Atlanta, Georgia, United States, 30342|
|United States, Michigan|
|Wayne State University, Harper Hospital|
|Detroit, Michigan, United States, 48201|
|United States, North Carolina|
|Winston Salem, North Carolina, United States, 27103|
|United States, Oklahoma|
|University of Oklahoma|
|Tulsa, Oklahoma, United States, 74104|
|United States, Pennsylvania|
|Temple University Hospital|
|Philadelphia, Pennsylvania, United States, 19140|
|Principal Investigator:||Ashwin Chatwani, M.D.||Temple University|
|Principal Investigator:||Jack Sobel, M.D.||Wayne State University|