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Audiovisual Stimulus During Urodynamics (AVUDE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02670486
Recruitment Status : Completed
First Posted : February 1, 2016
Last Update Posted : May 10, 2017
Sponsor:
Information provided by (Responsible Party):
Vivian Sung, Women and Infants Hospital of Rhode Island

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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Other: Audiovisual stimulus Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Audiovisual Stimulus During Urodynamics to Provoke Detrusor Overactivity
Study Start Date : August 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: standard of care
Usual urodynamics with no intervention.
Active Comparator: Audiovisual intervention
Audiovisual stimulus during urodynamic testing.
Other: Audiovisual stimulus
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 Measures :
  1. Proportion of patients in whom detrusor contractions are seen [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  1. Presence of incontinence associated with a contraction [ Time Frame: 30 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02670486


Sponsors and Collaborators
Women and Infants Hospital of Rhode Island
Investigators
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Study Chair: Alexandra Caffrey, BS Women & Infants Hospital IRB
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Responsible Party: Vivian Sung, PI, Women and Infants Hospital of Rhode Island
ClinicalTrials.gov Identifier: NCT02670486    
Other Study ID Numbers: 14-0034
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: May 10, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Vivian Sung, Women and Infants Hospital of Rhode Island:
Overactive bladder
Urge urinary incontinence
Urodynamics
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations