| November 6, 2006 |
| September 24, 2008 |
| November 2006 |
| December 2010 (final data collection date for primary outcome measure) |
| Overall satisfaction with menstrual strategy. [ Time Frame: Unspecified ] [ Designated as safety issue: No ] |
| Overall satisfaction with menstrual strategy. |
| Complete list of historical versions of study NCT00397202 on ClinicalTrials.gov Archive Site |
- 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 ]
|
- Diagnosed UTI
- Diagnosed vaginitis
- Vaginal irritation
- Waste
- Cost
|
| |
| FLOW-Finding Lasting Options for Women |
| FLOW-Finding Lasting Options for Women: A Prospective, Randomized, Multicenter Trial Comparing Tampons to a Menstrual Cup |
- 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.
|
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. |
| |
| Interventional |
| Other, Randomized, Open Label, Historical Control, Parallel Assignment, Efficacy Study |
| Menstruation |
| Device: Diva Cup TM |
| |
| |
| |
| Recruiting |
| 100 |
| December 2010 |
| December 2010 (final data collection date for primary outcome measure) |
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
|
| Female |
| 19 Years to 40 Years |
| Yes |
|
|
| Canada |
| |
| NCT00397202 |
| Dr. Konia Trouton, University of British Columbia |
| C06-0478 |
| University of British Columbia |
| National Research System-College of Family Physicians of Canada |
| Principal Investigator: |
Konia Trouton, MD |
University of British Columbia |
|
|
| University of British Columbia |
| September 2008 |
