FLOW-Finding Lasting Options for Women
- 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||FLOW-Finding Lasting Options for Women: A Prospective, Randomized, Multicenter Trial Comparing Tampons to a Menstrual Cup|
- Overall satisfaction with menstrual strategy. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
- Diagnosed UTI [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
- Diagnosed vaginitis [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
- Vaginal irritation [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
- Waste [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
- Cost [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||December 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: The DivaCupTM||
Device: Diva Cup TM
See Detailed Description.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00397202
|Contact: Konia Trouton||250 480 firstname.lastname@example.org|
|Canada, British Columbia|
|Private family physician offices||Recruiting|
|Victoria, Vancouver, Prince George, British Columbia, Canada|
|Contact: Konia Trouton, MD email@example.com|
|Principal Investigator: Konia Trouton, MD|
|Principal Investigator: Courtney Howard, MD|
|Principal Investigator:||Konia Trouton, MD||University of British Columbia|