Trial record 5 of 41 for:    Open Studies | "Vaginitis"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2007 by Abbott Research Group.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Abbott Research Group
ClinicalTrials.gov Identifier:
NCT00417365
First received: December 28, 2006
Last updated: August 13, 2007
Last verified: August 2007
  Purpose

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 Intervention
Vaginal Odor
Device: WaterWorks Douching Device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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"

Further study details as provided by Abbott Research Group:

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.

Estimated Enrollment: 100
Study Start Date: August 2006
Estimated Study Completion Date: September 2007
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00417365

Locations
United States, Florida
Segal Institute of Clinical Research Completed
Aventura, Florida, United States, 33161
Discovery Research, Inc. Withdrawn
Plantation, Florida, United States, 33324
United States, Georgia
Atlanta Women's Research Institute Active, not recruiting
Atlanta, Georgia, United States, 30342
United States, Michigan
Wayne State University, Harper Hospital Recruiting
Detroit, Michigan, United States, 48201
Contact: Debbie Leaman    313-577-5296    dleaman@med.wayne.edu   
Principal Investigator: Jack Sobel, M.D.         
United States, North Carolina
Salem Research Recruiting
Winston Salem, North Carolina, United States, 27103
Contact: Adrianna Fulda    336-760-3909    afulda@salemresearch.com   
Contact: Patricia Creed    (336) 760-3909    pcreed@salemresearch.com   
Principal Investigator: Thomas Valaoras, M.D.         
United States, Oklahoma
University of Oklahoma Terminated
Tulsa, Oklahoma, United States, 74104
United States, Pennsylvania
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Sarminia Hassan, M.D.    215-707-7278    shassan@temple.edu   
Principal Investigator: Ashwin Chatwni, M.D.         
Sponsors and Collaborators
Abbott Research Group
Investigators
Principal Investigator: Ashwin Chatwani, M.D. Temple University
Principal Investigator: Jack Sobel, M.D. Wayne State University
  More Information

Additional Information:
No publications provided by Abbott Research Group

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00417365     History of Changes
Other Study ID Numbers: ARG105B, Pre-IDE I060071
Study First Received: December 28, 2006
Last Updated: August 13, 2007
Health Authority: United States: Institutional Review Board

Keywords provided by Abbott Research Group:
odor
douching
BV
vaginitis
vaginal
yeast
ecosystem
Lactobacilli
Nugent
Amsel

Additional relevant MeSH terms:
Vaginitis
Vaginal Diseases
Genital Diseases, Female

ClinicalTrials.gov processed this record on August 26, 2014