Does Patient Activity Level Affect 24-Hour Pad Test Results in Stress-Incontinent Women
Primary Purpose
24-hour Pad Test Weight Gain With and Without Activity
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
minimal activity
Sponsored by
About this trial
This is an interventional diagnostic trial for 24-hour Pad Test Weight Gain With and Without Activity focused on measuring 24-hour pad test, Activity, Stress urinary incontinence
Eligibility Criteria
Inclusion Criteria:
- Stress urinary incontinence
Exclusion Criteria:
- language other than english
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
24-hour pad test
Arm Description
decreased activity
Outcomes
Primary Outcome Measures
24-hour pad test weight gain (mls)
Secondary Outcome Measures
Full Information
NCT ID
NCT01749527
First Posted
December 11, 2012
Last Updated
December 12, 2012
Sponsor
St George Hospital, Australia
1. Study Identification
Unique Protocol Identification Number
NCT01749527
Brief Title
Does Patient Activity Level Affect 24-Hour Pad Test Results in Stress-Incontinent Women
Official Title
Does Patient Activity Level Affect 24-Hour Pad Test Results in Stress-Incontinent Women?
Study Type
Interventional
2. Study Status
Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
March 2006 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St George Hospital, Australia
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
We hypothesised that in women with stress urinary incontinence, the severity of leakage on a 24 hour pad test was affected by activity.
Detailed Description
We asked women to perform two separate pad tests, one with normal activity, and another with decreased activity.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
24-hour Pad Test Weight Gain With and Without Activity
Keywords
24-hour pad test, Activity, Stress urinary incontinence
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
24-hour pad test
Arm Type
Other
Arm Description
decreased activity
Intervention Type
Behavioral
Intervention Name(s)
minimal activity
Intervention Description
Pad test with minimal activity
Primary Outcome Measure Information:
Title
24-hour pad test weight gain (mls)
Time Frame
24 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Stress urinary incontinence
Exclusion Criteria:
language other than english
12. IPD Sharing Statement
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Does Patient Activity Level Affect 24-Hour Pad Test Results in Stress-Incontinent Women
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