Ignite Creation Date:
2025-12-25 @ 3:44 AM
Ignite Modification Date:
2025-12-26 @ 2:30 AM
Study NCT ID:
NCT00397202
Status:
COMPLETED
Last Update Posted:
2015-04-30
First Post:
2006-11-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
FLOW-Finding Lasting Options for Women
Sponsor:
University of British Columbia
Organization:
Study Overview
Official Title:
FLOW-Finding Lasting Options for Women: A Prospective, Randomized, Multicenter Trial Comparing Tampons to a Menstrual Cup
Status:
COMPLETED
Status Verified Date:
2015-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: