FLOW-Finding Lasting Options for Women

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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FLOW-Finding Lasting Options for Women: A Prospective, Randomized, Multicenter Trial Comparing Tampons to a Menstrual Cup

Conditions
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Menstruation

Intervention / Treatment
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* Device: Diva Cup TM


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: The DivaCupTM<br> | Device: Diva Cup TM<br>* See Detailed Description.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall satisfaction with menstrual strategy. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosed UTI |  |  | 
| Diagnosed vaginitis |  |  | 
| Vaginal irritation |  |  | 
| Waste |  |  | 
| Cost |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Menstruation