FLOW-Finding Lasting Options for Women

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of British Columbia
Sponsor:
Collaborator:
National Research System-College of Family Physicians of Canada
Information provided by (Responsible Party):
University of British Columbia
ClinicalTrials.gov Identifier:
NCT00397202
First received: November 6, 2006
Last updated: July 30, 2013
Last verified: July 2013
  Purpose
  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.

Condition Intervention
Menstruation
Device: Diva Cup TM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: FLOW-Finding Lasting Options for Women: A Prospective, Randomized, Multicenter Trial Comparing Tampons to a Menstrual Cup

Resource links provided by NLM:


Further study details as provided by University of British Columbia:

Primary Outcome Measures:
  • Overall satisfaction with menstrual strategy. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 100
Study Start Date: November 2006
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: The DivaCupTM Device: Diva Cup TM
See Detailed Description.

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.

  Eligibility

Ages Eligible for Study:   19 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00397202

Contacts
Contact: Konia Trouton 250 480 7333 ktrouton@uvic.ca

Locations
Canada, British Columbia
Private family physician offices Recruiting
Victoria, Vancouver, Prince George, British Columbia, Canada
Contact: Konia Trouton, MD       ktrouton@uvic.ca   
Principal Investigator: Konia Trouton, MD         
Principal Investigator: Courtney Howard, MD         
Sponsors and Collaborators
University of British Columbia
National Research System-College of Family Physicians of Canada
Investigators
Principal Investigator: Konia Trouton, MD University of British Columbia
  More Information

No publications provided

Responsible Party: University of British Columbia
ClinicalTrials.gov Identifier: NCT00397202     History of Changes
Other Study ID Numbers: C06-0478
Study First Received: November 6, 2006
Last Updated: July 30, 2013
Health Authority: Canada: Health Canada

Keywords provided by University of British Columbia:
Menstruation

ClinicalTrials.gov processed this record on August 20, 2014