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OpenTrials
Completed

NCT Number: NCT00397202

FLOW-Finding Lasting Options for Women

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.

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Key information

Conditions

Menstruation

Age range

19 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Private family physician offices

Victoria, Vancouver, Prince George, British Columbia, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Diva Cup TM

Device

See Detailed Description.

Primary outcomes

  1. Overall satisfaction with menstrual strategy.

Secondary outcomes

  1. Diagnosed UTI

  2. Diagnosed vaginitis

  3. Vaginal irritation

  4. Waste

  5. Cost

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • National Research System-College of Family Physicians of Canada

Registry information

Official study title

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

Important dates

Study start
2006
Primary completion
2009
Study completion
2011
First posted
Nov 8, 2006
Registry last updated
Apr 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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