Efficacy of (WaterWorks®)Douching Device for Elimination of Perceived Vaginal Odor Not Caused by BV or Vaginitis

Sponsor

Abbott Research Group (Industry)

Overall Status

Unknown status

CT.gov ID

NCT00417365

Collaborator

(none)

100

Enrollment

Locations

Duration (Months)

14.3

Patients Per Site

1.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Vaginal Odor	Device: WaterWorks Douching Device	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (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"

Study Start Date :

Aug 1, 2006

Anticipated Study Completion Date :

Sep 1, 2007

Outcome Measures

Primary Outcome Measures

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". []

Secondary Outcome Measures

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. []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Enrollment in the study will be open to those subjects who meet the following inclusion criteria:

Non-pregnant females, 18 years and older
Complaint of abnormal vaginal odor with or without complaints of discharge
Subject with perceived, abnormal vaginal odor on the date she is evaluated
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
Subject is not fulfilling Amsel's criteria for BV listed below (only meets 0 or 1 Amsel's criteria)
Not treated for Bacterial Vaginosis, VVC, intra-vaginal or oral anti-fungal medications or antibiotics, within the last 14 days of enrollment
Willing and able to comply with study requirements
Has provided written informed consent

Exclusion Criteria:

Subjects will be excluded from the enrollment if they have any of the following:

Odor scale less than 4 cm (on the Visual Analog rating scale of 10 cm)
Subjects with presence of BV
Subjects with other lower genital tract infections (e.g., symptomatic VVC, trichomoniasis, Chlamydia trachomatis, Neisseria gonorrhoeae or herpes simplex virus)
Subjects with another vaginal or vulvar condition, which would confound the interpretation of clinical response
Subjects who received antifungal or antimicrobial therapy (systemic or intravaginal) within the last 14 days
Subjects who will be under treatment during the study period for cervical intra-epithelial neoplasia (CIN) or cervical carcinoma
Positive pregnancy test
Any abnormal anatomy or pathology of the subject's vagina
Known HIV positive
Pap smear >LSIL (untreated or not evaluated) [LSIL = Low-grade squamous intraepithelial lesion]
Subject currently having a menstrual period (excluded until completion of period)
Subjects with a body mass index (BMI) of 39 or greater
Investigator believes that external factor(s) is producing odor

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Segal Institute of Clinical Research	Aventura	Florida	United States	33161
2	Discovery Research, Inc.	Plantation	Florida	United States	33324
3	Atlanta Women's Research Institute	Atlanta	Georgia	United States	30342
4	Wayne State University, Harper Hospital	Detroit	Michigan	United States	48201
5	Salem Research	Winston Salem	North Carolina	United States	27103
6	University of Oklahoma	Tulsa	Oklahoma	United States	74104
7	Temple University Hospital	Philadelphia	Pennsylvania	United States	19140