Overactive BladderAVUDENCT02670486
Audiovisual Stimulus During Urodynamics
A study testing Audiovisual stimulus in people with Overactive Bladder, run by Women and Infants Hospital of Rhode Island.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Audiovisual stimulus
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 218 participants
- Where
- No sites listed yet
- Study dates
- Aug 2014to Jun 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- women 18 years and older undergoing UDE with clinical diagnosis of OAB and/or UUI
Who cannot join
- 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
About this study
Official title: Audiovisual Stimulus During Urodynamics to Provoke Detrusor Overactivity
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.
Read the 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.
- Conditions
- Overactive Bladder
- Being tested
- Audiovisual stimulus
- Keywords
- Overactive bladder, Urge urinary incontinence, Urodynamics
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Audiovisual stimulusOther
Water fountain and a video (including scenes of some common triggers for OAB) played on continuous loop throughout the test on a laptop
| Study group | Role | What they receive |
|---|---|---|
| standard of care | No intervention | Usual urodynamics with no intervention. |
| Audiovisual intervention | Active comparator | Audiovisual stimulus during urodynamic testing. Receives: Other: Audiovisual stimulus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients in whom detrusor contractions are seen
Measured: 30 minutes
Secondary outcomes (1)
Presence of incontinence associated with a contraction
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startAug 2014
- Primary completionMay 2016
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Women and Infants Hospital of Rhode Island
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vivian Sung, Women and Infants Hospital of Rhode Island
- Investigators
- Alexandra Caffrey, BS, Study chair, Women & Infants Hospital IRB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02670486
- Sponsor's protocol ID
- 14-0034
- Acronym
- AVUDE
- Status last verified
- May 2017
- First submitted
- 9 Oct 2015
- Last updated
- 10 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Audiovisual Stimulus During Urodynamics to Provoke Detrusor Overactivity
- ClinicalTrials.gov ID
- NCT02670486
- Acronym / sponsor ID
- AVUDE / 14-0034
- Conditions
- Overactive Bladder
- Keywords
- Overactive bladder, Urge urinary incontinence, Urodynamics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Women and Infants Hospital of Rhode IslandUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard of care | No intervention | –Usual urodynamics with no intervention. |
| Audiovisual intervention | Active comparator | Other: Audiovisual stimulusAudiovisual stimulus during urodynamic testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- women 18 years and older undergoing UDE with clinical diagnosis of OAB and/or UUI
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Audiovisual stimulusWater fountain and a video (including scenes of some common triggers for OAB) played on continuous loop throughout the test on a laptop | Other | Audiovisual intervention |
Primary outcome
Proportion of patients in whom detrusor contractions are seen
Time frame: 30 minutes
1 secondary outcome
Presence of incontinence associated with a contraction
Time frame: 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandra Caffrey, BS study chair
Women & Infants Hospital IRB
Questions about this trial
What is this clinical trial studying?
A study testing Audiovisual stimulus in people with Overactive Bladder, run by Women and Infants Hospital of Rhode Island.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients in whom detrusor contractions are seen (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2017.