Vaginal OdorNCT00417365
Efficacy of (WaterWorks®)Douching Device for Elimination of Perceived Vaginal Odor Not Caused by BV or Vaginitis
A study testing WaterWorks Douching Device in people with Vaginal Odor, run by Abbott Research Group at 7 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vaginal Odor
- What is being tested?
- WaterWorks Douching Device
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 7 sitesUnited States
- Study dates
- Aug 2006to Sep 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 9Show fewer
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites, 3 recruiting
- Active, not recruiting
Atlanta Women's Research Institute
Atlanta, Georgia, 30342
- Completed
Segal Institute of Clinical Research
Aventura, Florida, 33161
- Recruiting
Wayne State University, Harper Hospital
Detroit, Michigan, 48201
Debbie Leaman, 313-577-5296, dleaman@med.wayne.edu
Jack Sobel, M.D.
- Recruiting
Temple University Hospital
Philadelphia, Pennsylvania, 19140
Sarminia Hassan, M.D., 215-707-7278, shassan@temple.edu
Ashwin Chatwni, M.D.
- Withdrawn
Discovery Research, Inc.
Plantation, Florida, 33324
- Terminated
University of Oklahoma
Tulsa, Oklahoma, 74104
- Recruiting
Salem Research
Winston-Salem, North Carolina, 27103
Adrianna Fulda, 336-760-3909, afulda@salemresearch.com
Patricia Creed, (336) 760-3909, pcreed@salemresearch.com
About this study
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"
Comparing the new Stainless Steel WaterWorks® douching device to a commercially available douching device using just water for safety and efficacy of odor abatement.
Read the 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.
- Conditions
- Vaginal Odor
- Being tested
- WaterWorks Douching Device
- Keywords
- odor, douching, BV, vaginitis, vaginal, yeast, ecosystem, Lactobacilli, Nugent, Amsel
- Medical subject headings
- Vaginitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WaterWorks Douching DeviceDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
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 outcomes (5)
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2007 (estimated)
- Study startAug 2006
- Study completionSep 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Vaginal OdorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Abbott Research Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Ashwin Chatwani, M.D., Principal investigator, Temple UniversityJack Sobel, M.D., Principal investigator, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00417365
- Sponsor's protocol ID
- ARG105B
- Other IDs
- Pre-IDE I060071
- Status last verified
- Aug 2007
- First submitted
- 28 Dec 2006
- Last updated
- 15 Aug 2007
- Results posted
- No
Publications
Infectious Diseases in Obstetrics and Gynecology Volume 2006 (2006), Article ID 95618, 4 pages doi:10.1155/IDOG/2006/95618 /Published results are from ARG sponsored study ARG105.
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.
PubMed 21263351
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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"
- ClinicalTrials.gov ID
- NCT00417365
- Acronym / sponsor ID
- ARG105B
- Conditions
- Vaginal Odor
- Keywords
- odor, douching, BV, vaginitis, vaginal, yeast, ecosystem, Lactobacilli
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Abbott Research GroupIndustry (pharma, biotech, devices)
- Study start
- Aug 2006
- Study completion
- Sep 2007 (estimated)
- First posted
- 1 Jan 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WaterWorks Douching Device | Device | – |
Primary outcome
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".
5 secondary outcomes
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2007.
- BackgroundInfectious Diseases in Obstetrics and Gynecology Volume 2006 (2006), Article ID 95618, 4 pages doi:10.1155/IDOG/2006/95618 /Published results are from ARG sponsored study ARG105.
- Derived from this study: PubMed 21263351Hassan 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.
Related trials for Vaginal Odor
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Vaginal Odor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashwin Chatwani, M.D. principal investigator
Temple University
Jack Sobel, M.D. principal investigator
Wayne State University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WaterWorks Douching Device in people with Vaginal Odor, run by Abbott Research Group at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Aug 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary endpoint of the study is the reduction or abatement of the. The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00417365, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2007.