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FLOW-Finding Lasting Options for Women

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ClinicalTrials.gov Identifier: NCT00397202
Recruitment Status : Completed
First Posted : November 8, 2006
Last Update Posted : April 30, 2015
Sponsor:
Collaborator:
National Research System-College of Family Physicians of Canada
Information provided by (Responsible Party):
University of British Columbia

Brief Summary:
  1. Purpose: To compare the use of the menstrual cup "The DivaCupTM " to a menstrual strategy using tampons as the primary method of menstrual flow management using indicators of user-satisfaction, urinary tract infection, vaginal irritation, cost and waste.
  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.

Condition or disease Intervention/treatment Phase
Menstruation Device: Diva Cup TM Not Applicable

Detailed Description:

Method:

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 110 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: FLOW-Finding Lasting Options for Women: A Prospective, Randomized, Multicenter Trial Comparing Tampons to a Menstrual Cup
Study Start Date : November 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Menstruation
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: The DivaCupTM Device: Diva Cup TM
See Detailed Description.



Primary Outcome Measures :
  1. Overall satisfaction with menstrual strategy.

Secondary Outcome Measures :
  1. Diagnosed UTI
  2. Diagnosed vaginitis
  3. Vaginal irritation
  4. Waste
  5. Cost


Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Women between the ages of 19 and 40 who have menstrual flow most months and who currently self-identify as using tampons as their primary method of menstrual management

Exclusion Criteria:

  • Have a sensitivity or allergy to silicone
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00397202


Locations
Canada, British Columbia
Private family physician offices
Victoria, Vancouver, Prince George, British Columbia, Canada
Sponsors and Collaborators
University of British Columbia
National Research System-College of Family Physicians of Canada
Investigators
Principal Investigator: Konia Trouton, MD University of British Columbia

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00397202     History of Changes
Other Study ID Numbers: H06-70478
First Posted: November 8, 2006    Key Record Dates
Last Update Posted: April 30, 2015
Last Verified: April 2015

Keywords provided by University of British Columbia:
Menstruation