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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
St George Hospital, Australia
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

    First Posted
    December 11, 2012
    Last Updated
    December 12, 2012
    Sponsor
    St George Hospital, Australia
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    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

    Learn more about this trial

    Does Patient Activity Level Affect 24-Hour Pad Test Results in Stress-Incontinent Women

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