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
- 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.
- 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|
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|
|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|
|Active Comparator: The DivaCupTM||
Device: Diva Cup TM
See Detailed Description.
- Overall satisfaction with menstrual strategy.
- Diagnosed UTI
- Diagnosed vaginitis
- Vaginal irritation
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
|Canada, British Columbia|
|Private family physician offices|
|Victoria, Vancouver, Prince George, British Columbia, Canada|
|Principal Investigator:||Konia Trouton, MD||University of British Columbia|