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

August 13, 2007 updated by: Abbott Research Group

"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"

Comparing the new Stainless Steel WaterWorks® douching device to a commercially available douching device using just water for safety and efficacy of odor abatement.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Aventura, Florida, United States, 33161
        • Completed
        • Segal Institute of Clinical Research
      • Plantation, Florida, United States, 33324
        • Withdrawn
        • Discovery Research, Inc.
    • Georgia
      • Atlanta, Georgia, United States, 30342
        • Active, not recruiting
        • Atlanta Women's Research Institute
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Wayne State University, Harper Hospital
        • Contact:
        • Principal Investigator:
          • Jack Sobel, M.D.
    • North Carolina
      • Winston Salem, North Carolina, United States, 27103
        • Recruiting
        • Salem Research
        • Contact:
        • Contact:
        • Principal Investigator:
          • Thomas Valaoras, M.D.
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Terminated
        • University of Oklahoma
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
        • Recruiting
        • Temple University Hospital
        • Contact:
        • Principal Investigator:
          • Ashwin Chatwni, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abbott Research Group

Investigators

  • Principal Investigator: Ashwin Chatwani, M.D., Temple University
  • Principal Investigator: Jack Sobel, M.D., Wayne State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2006

Study Completion (ANTICIPATED)

September 1, 2007

Study Registration Dates

First Submitted

December 28, 2006

First Submitted That Met QC Criteria

December 29, 2006

First Posted (ESTIMATE)

January 1, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

August 15, 2007

Last Update Submitted That Met QC Criteria

August 13, 2007

Last Verified

August 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ARG105B
  • Pre-IDE I060071

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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