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

November 6, 2006
July 30, 2013
November 2006
December 2013   (final data collection date for primary outcome measure)
Overall satisfaction with menstrual strategy. [ Time Frame: Unspecified ] [ Designated as safety issue: No ]
Overall satisfaction with menstrual strategy.
Complete list of historical versions of study NCT00397202 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Diagnosed UTI
  • Diagnosed vaginitis
  • Vaginal irritation
  • Waste
  • Cost
Not Provided
Not Provided
 
FLOW-Finding Lasting Options for Women
FLOW-Finding Lasting Options for Women: A Prospective, Randomized, Multicenter Trial Comparing Tampons to a Menstrual Cup
  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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Menstruation
Device: Diva Cup TM
See Detailed Description.
Active Comparator: The DivaCupTM
Intervention: Device: Diva Cup TM
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Female
19 Years to 40 Years
Yes
Contact: Konia Trouton 250 480 7333 ktrouton@uvic.ca
Canada
 
NCT00397202
C06-0478
No
University of British Columbia
University of British Columbia
National Research System-College of Family Physicians of Canada
Principal Investigator: Konia Trouton, MD University of British Columbia
University of British Columbia
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP