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Audiovisual Stimulus During Urodynamics (AVUDE)

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Audiovisual stimulus
Sponsored by
Women and Infants Hospital of Rhode Island
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Overactive Bladder focused on measuring Overactive bladder, Urge urinary incontinence, Urodynamics

Eligibility Criteria

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

Inclusion Criteria:

  • women 18 years and older undergoing UDE with clinical diagnosis of OAB and/or UUI

Exclusion Criteria:

  • urinary tract infection
  • pregnancy
  • current treatment for OAB or UUI
  • stage 3 and 4 pelvic organ prolapse
  • undergone major pelvic reconstructive surgery or incontinence surgery in the last 6 months
  • neurogenic bladder

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    No Intervention

    Active Comparator

    Arm Label

    standard of care

    Audiovisual intervention

    Arm Description

    Usual urodynamics with no intervention.

    Audiovisual stimulus during urodynamic testing.

    Outcomes

    Primary Outcome Measures

    Proportion of patients in whom detrusor contractions are seen

    Secondary Outcome Measures

    Presence of incontinence associated with a contraction

    Full Information

    First Posted
    October 9, 2015
    Last Updated
    May 9, 2017
    Sponsor
    Women and Infants Hospital of Rhode Island
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02670486
    Brief Title
    Audiovisual Stimulus During Urodynamics
    Acronym
    AVUDE
    Official Title
    Audiovisual Stimulus During Urodynamics to Provoke Detrusor Overactivity
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2014 (undefined)
    Primary Completion Date
    May 2016 (Actual)
    Study Completion Date
    June 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Women and Infants Hospital of Rhode Island

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Many women have the need to run to the restroom frequently during the night and day, a condition called "overactive bladder". Embarrassing urinary leakage is also commonly associated with these symptoms. The investigators believe the primary cause in most cases is the bladder muscle contracting too frequently but are still not sure exactly why this happens and if it is triggered by factors in the environment. When bladder testing using pressure catheters ("urodynamics") is done these bladder contractions are often not picked up, even in women with overactive bladder. This may be partly due to the unnatural environment in which the testing is done without the presence of the usual visual or audible triggers, such as running water or seeing a toilet. The investigators propose adding an audiovisual stimulant to the usual bladder testing to see if this makes it more likely for bladder contractions to happen. One group of patients would have the usual bladder testing as part of their normal care. The other group would receive the normal care in addition to hearing a water fountain in the room and watching a video of things that may trigger overactive bladder symptoms; seeing public restroom signs in a mall, a toilet bowl being lowered and a kitchen sink with water running over dishes. The suspicion is that the proportion of patients in whom bladder contractions are seen will be higher for those with audiovisual triggers compared to those with the usual care. Women with overactive bladder or leakage with urge who are sent for urodynamics by their doctor will be asked if they wish to participate in the study.
    Detailed Description
    Detrusor overactivity (DO), defined as a rise in detrusor pressure during bladder filling on urodynamic evaluation (UDE), is presumed to be involved in the pathophysiology of overactive bladder syndrome (OAB) and urge urinary incontinence (UUI). However, the mechanism of DO is not fully understood and the detection rate of DO on UDE is low. Currently there is limited data in the literature investigating audiovisual stimulation of DO. To improve the understanding of the neural regulation of micturition, the investigators propose adding an audiovisual stimulant to standard UDE. Methods: 218 women with OAB and/or UUI undergoing UDE will be recruited. Subjects will be randomized to standard care versus standard care with the addition of an audiovisual stimulant, involving the patient listening to running water and watching a video of several well-known triggers. The primary outcome will be proportion of patients in whom detrusor contractions are seen. Secondary outcomes will include number, amplitude and length of contractions and presence of incontinence associated with a contraction. The objective of this study is to estimate the effect of adding audiovisual cues during UDE on the proportion of patients in whom DO is detected compared to standard clinical care. The hypothesis is that the proportion of patients in whom detrusor contractions are seen will be higher in female patients with OAB symptoms and/or UUI using an audiovisual stimulant. Data obtained will be analyzed by chi square, t-tests, and multivariable logistic regression analysis as appropriate.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Overactive Bladder
    Keywords
    Overactive bladder, Urge urinary incontinence, Urodynamics

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    218 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    standard of care
    Arm Type
    No Intervention
    Arm Description
    Usual urodynamics with no intervention.
    Arm Title
    Audiovisual intervention
    Arm Type
    Active Comparator
    Arm Description
    Audiovisual stimulus during urodynamic testing.
    Intervention Type
    Other
    Intervention Name(s)
    Audiovisual stimulus
    Intervention Description
    Water fountain and a video (including scenes of some common triggers for OAB) played on continuous loop throughout the test on a laptop
    Primary Outcome Measure Information:
    Title
    Proportion of patients in whom detrusor contractions are seen
    Time Frame
    30 minutes
    Secondary Outcome Measure Information:
    Title
    Presence of incontinence associated with a contraction
    Time Frame
    30 minutes

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: women 18 years and older undergoing UDE with clinical diagnosis of OAB and/or UUI Exclusion Criteria: urinary tract infection pregnancy current treatment for OAB or UUI stage 3 and 4 pelvic organ prolapse undergone major pelvic reconstructive surgery or incontinence surgery in the last 6 months neurogenic bladder
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Alexandra Caffrey, BS
    Organizational Affiliation
    Women & Infants Hospital IRB
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Audiovisual Stimulus During Urodynamics

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