Ignite Creation Date:
2024-05-05 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417365
Status:
UNKNOWN
Last Update Posted:
2007-08-15
First Post:
2006-12-28
Brief Title:
Efficacy of WaterWorksDouching Device for Elimination of Perceived Vaginal Odor Not Caused by BV or Vaginitis
Sponsor:
Abbott Research Group
Organization:
Abbott Research Group
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2007-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Pre-IDE I060071 | None | None | None |