Efficacy of (WaterWorksÂ®)Douching Device for Elimination of Perceived Vaginal Odor Not Caused by BV or Vaginitis
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.
Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
WaterWorks Douching Device
Segal Institute of Clinical Research
Abbott Research Group
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00417365
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
The washing of the VAGINA cavity or surface with a solution. Agents or drugs can be added to the irrigation solution.
Collection of pooled secretions of the posterior vaginal fornix for cytologic examination.
Safety-based Medical Device Withdrawals
Removal of a MEDICAL DEVICE from the market due to the identification of an intrinsic property of the device that results in a serious risk to public health.
An incision of the posterior vaginal wall and a portion of the pudenda which enlarges the vaginal introitus to facilitate delivery and prevent lacerations.
Medical Device Recalls
Removal of a MEDICAL DEVICE from the market due to a problem occurring in the manufacture or distribution of the product.
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