Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2006-11-30
2011-06-30
Brief Summary
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2. Hypothesis: The "The DivaCupTM" will have similar rates of user-satisfaction, urinary tract infection, and vaginal irritation as a menstrual strategy using tampons as the primary method of menstrual flow management but will likely be more reasonable in terms of cost and will generate less waste.
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Detailed Description
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Prospective study of 100 women from family practice offices in Vancouver, Victoria and Prince George who currently use tampons to manage menstrual flow. After an information session and consent, subjects will be randomized to tampon use or Diva Cup use and record their experience on a diary for 3 months. Women who attend the information session and who do not enrol, or those who drop out will be asked their reasons for discontinuing, and their pre-study questionnaire will be used for analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
NONE
Study Groups
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The DivaCupTM
Diva Cup TM
See Detailed Description.
Interventions
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Diva Cup TM
See Detailed Description.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Have an active vaginal or urogenital infection
* Are pregnant, or who have plans to become pregnant before spring 2007 (end of study data collection)
* Have used systemic antimicrobials within the previous 14 days
* Are unable to understand the nature and purpose of the study
* Are unable to understand and express themselves in written and spoken English
19 Years
40 Years
FEMALE
Yes
Sponsors
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National Research System-College of Family Physicians of Canada
NETWORK
University of British Columbia
OTHER
Responsible Party
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Principal Investigators
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Konia Trouton, MD
Role: PRINCIPAL_INVESTIGATOR
University of British Columbia
Locations
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Private family physician offices
Victoria, Vancouver, Prince George, British Columbia, Canada
Countries
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References
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Howard C, Rose CL, Trouton K, Stamm H, Marentette D, Kirkpatrick N, Karalic S, Fernandez R, Paget J. FLOW (finding lasting options for women): multicentre randomized controlled trial comparing tampons with menstrual cups. Can Fam Physician. 2011 Jun;57(6):e208-15.
Other Identifiers
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H06-70478
Identifier Type: -
Identifier Source: org_study_id
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