FLOW-Finding Lasting Options for Women

Menstruation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00397202
• Other study ID #: H06-70478
• Status: Completed
• Phase: N/A
• First received: November 6, 2006
• Last updated: April 29, 2015
• Start date: November 2006
• Est. completion date: June 2011

Study information

• Verified date: April 2015
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2011
• Est. primary completion date: June 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Menstruation

Intervention

Device:
• Diva Cup TM
See Detailed Description.

Locations

Country	Name	City	State
Canada	Private family physician offices	Victoria, Vancouver, Prince George	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	National Research System-College of Family Physicians of Canada

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall satisfaction with menstrual strategy.		Unspecified	No
Secondary	Diagnosed UTI		Unspecified	No
Secondary	Diagnosed vaginitis		Unspecified	No
Secondary	Vaginal irritation		Unspecified	No
Secondary	Waste		Unspecified	No
Secondary	Cost		Unspecified	No