FLOW-Finding Lasting Options for Women
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.
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 Design
Allocation: Randomized, Control: Historical Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label
Conditions
Menstruation
Intervention
Diva Cup TM
Location
Private family physician offices
Victoria, Vancouver, Prince George
British Columbia
Canada
Status
Recruiting
Source
University of British Columbia
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00397202
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Menstruation Disturbances
Variations of menstruation which may be indicative of disease.
Menstruation-inducing Agents
Chemical compounds that induce menstruation either through direct action on the reproductive organs or through indirect action by relieving another condition of which amenorrhea is a secondary result. (From Dorland, 27th ed)
Menstruation
The periodic shedding of the ENDOMETRIUM and associated menstrual bleeding in the MENSTRUAL CYCLE of humans and primates. Menstruation is due to the decline in circulating PROGESTERONE, and occurs at the late LUTEAL PHASE when LUTEOLYSIS of the CORPUS LUTEUM takes place.
Amenorrhea
Absence of menstruation.
Dysmenorrhea
Painful menstruation.
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PubMed Articles
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