FLOW-Finding Lasting Options for Women

Not Applicable

Completed

• Conditions: Menstruation
• Interventions: Device: Diva Cup TM

• Registration Number: NCT00397202
• Lead Sponsor: University of British Columbia

Brief 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.

Detailed 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 Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-06
• Study First Submitted QC: 2006-11-07
• Study First Posted: 2006-11-08
• Primary Completion: 2009-06
• Study Completion: 2011-06
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-29
• Last Update Posted: 2015-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
The DivaCupTM	Diva Cup TM	-

Primary Outcome Measures

Name	Time	Method
Overall satisfaction with menstrual strategy.

Secondary Outcome Measures

Name	Time	Method
Diagnosed UTI
Waste
Cost
Vaginal irritation
Diagnosed vaginitis

Trial Locations

Locations (1)

Private family physician offices; 🇨🇦 Victoria, Vancouver, Prince George, British Columbia, Canada