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

Primary Purpose

Vaginal Odor

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
WaterWorks Douching Device
Sponsored by
Abbott Research Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vaginal Odor focused on measuring odor, douching, BV, vaginitis, vaginal, yeast, ecosystem, Lactobacilli, Nugent, Amsel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

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

  1. Non-pregnant females, 18 years and older
  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:

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

  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

Sites / Locations

  • Segal Institute of Clinical Research
  • Discovery Research, Inc.
  • Atlanta Women's Research Institute
  • Wayne State University, Harper HospitalRecruiting
  • Salem ResearchRecruiting
  • University of Oklahoma
  • Temple University HospitalRecruiting

Outcomes

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.

Full Information

First Posted
December 28, 2006
Last Updated
August 13, 2007
Sponsor
Abbott Research Group
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1. Study Identification

Unique Protocol Identification Number
NCT00417365
Brief Title
Efficacy of (WaterWorks®)Douching Device for Elimination of Perceived Vaginal Odor Not Caused by BV or Vaginitis
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 Type
Interventional

2. Study Status

Record Verification Date
August 2007
Overall Recruitment Status
Unknown status
Study Start Date
August 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2007 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Abbott Research Group

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vaginal Odor
Keywords
odor, douching, BV, vaginitis, vaginal, yeast, ecosystem, Lactobacilli, Nugent, Amsel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
WaterWorks Douching Device
Primary Outcome Measure Information:
Title
The primary endpoint of the study is the reduction or abatement of the
Title
subject's perceived vaginal odor as determined at Visit 3.
Title
This improvement will be measured using a visual analog scale that
Title
asks subjects to rate their perception of vaginal odor on a scale that
Title
is anchored at two extremes, "no odor", and, "strong offensive odor".
Secondary Outcome Measure Information:
Title
Effects on the vaginal Eco-System will be assessed using the
Title
Lactobacilli score and the Nugent score. The safety profile of the douching
Title
device (Water Works® versus control) will be assessed through the collection
Title
of any reported adverse events. Any adverse event, will be reported in terms
Title
of severity, relationship to treatment, duration, and resolution.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashwin Chatwani, M.D.
Organizational Affiliation
Temple University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jack Sobel, M.D.
Organizational Affiliation
Wayne State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Segal Institute of Clinical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33161
Country
United States
Individual Site Status
Completed
Facility Name
Discovery Research, Inc.
City
Plantation
State/Province
Florida
ZIP/Postal Code
33324
Country
United States
Individual Site Status
Withdrawn
Facility Name
Atlanta Women's Research Institute
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Wayne State University, Harper Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debbie Leaman
Phone
313-577-5296
Email
dleaman@med.wayne.edu
First Name & Middle Initial & Last Name & Degree
Jack Sobel, M.D.
Facility Name
Salem Research
City
Winston Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adrianna Fulda
Phone
336-760-3909
Email
afulda@salemresearch.com
First Name & Middle Initial & Last Name & Degree
Patricia Creed
Phone
(336) 760-3909
Email
pcreed@salemresearch.com
First Name & Middle Initial & Last Name & Degree
Thomas Valaoras, M.D.
Facility Name
University of Oklahoma
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74104
Country
United States
Individual Site Status
Terminated
Facility Name
Temple University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarminia Hassan, M.D.
Phone
215-707-7278
Email
shassan@temple.edu
First Name & Middle Initial & Last Name & Degree
Ashwin Chatwni, M.D.

12. IPD Sharing Statement

Citations:
PubMed Identifier
17485816
Citation
Chatwani AJ, Hassan S, Rahimi S, Jeronis S, Dandolu V. Douching with Water Works device for perceived vaginal odor with or without complaints of discharge in women with no infectious cause of vaginitis: a pilot study. Infect Dis Obstet Gynecol. 2006;2006:95618. doi: 10.1155/IDOG/2006/95618.
Results Reference
background
PubMed Identifier
21263351
Citation
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.
Results Reference
derived

Learn more about this trial

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

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