Audiovisual Stimulus During Urodynamics (AVUDE)
Primary Purpose
Overactive Bladder
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Audiovisual stimulus
Sponsored by
About this trial
This is an interventional basic science trial for Overactive Bladder focused on measuring Overactive bladder, Urge urinary incontinence, Urodynamics
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
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
NCT ID
NCT02670486
First Posted
October 9, 2015
Last Updated
May 9, 2017
Sponsor
Women and Infants Hospital of Rhode Island
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
Learn more about this trial
Audiovisual Stimulus During Urodynamics
We'll reach out to this number within 24 hrs