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Trial registered on ANZCTR
Registration number
ACTRN12619000547145
Ethics application status
Approved
Date submitted
23/11/2018
Date registered
8/04/2019
Date last updated
8/04/2019
Date data sharing statement initially provided
8/04/2019
Date results information initially provided
8/04/2019
Type of registration
Retrospectively registered
Titles & IDs
Public title
A research study to see if infrared light applied via the nostril is safe and will help reduce symptoms for people with overactive bladder.
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Scientific title
An evaluation of the safety and efficacy of photobiomodulation on symptoms of an overactive bladder. Part 1.
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Secondary ID [1]
295621
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Nil known
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Universal Trial Number (UTN)
U1111-1217-8587
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Trial acronym
The ROSE Study Part 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Overactive Bladder
308950
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Condition category
Condition code
Renal and Urogenital
307847
307847
0
0
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Other renal and urogenital disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Near infrared light (NIRL), using a Vielight 810 device, will be delivered to participants through a diode placed in their nasal cavity for the duration of their second cystometric fill (up to 25 minutes). Cystometry is a test used to look for problems with the filling and emptying of the bladder. During the filling phase of the test (cystometric fill), the bladder is filled with saline solution, bladder pressures measured and the patient asked about their urge to void. This process will occur during participants' Urology outpatient clinic appointments and will only occur once.
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Intervention code [1]
301926
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Treatment: Devices
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Comparator / control treatment
No control group.
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
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Change in detrusor pressure at first involuntary detrusor contraction.
Detrusor pressure (the pressure generated by the walls of the bladder) is calculated by subtracting the intra-abdominal pressure (measured via a rectal catheter) from the intravesical pressure (measured via a bladder catheter). The first involuntary detrusor contraction is the first occurrence of the bladder muscle squeezing without warning causing an urgent need to release urine; it is seen graphically during urodynamic assessment.
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Assessment method [1]
306824
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Timepoint [1]
306824
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First and second cystometric fills; the latter being with NIRL insitu.
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Primary outcome [2]
308232
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Change in bladder volume at first involuntary detrusor contraction.
Bladder volume refers to the millilitres of saline instilled into the bladder during cystometric filling. The first involuntary detrusor contraction is the first occurrence of the bladder muscle squeezing without warning causing an urgent need to release urine; it is seen graphically during urodynamic assessment.
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Assessment method [2]
308232
0
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Timepoint [2]
308232
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First and second cystometric fills; the latter being with NIRL insitu.
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Primary outcome [3]
308233
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Occurrence of an adverse event.
i) A clinically significant rise in systolic or diastolic blood pressure defined as >=30mmHg.
Measured using an automated blood pressure machine with cuff fitted to a participant's
upper arm.
ii) Any unintended and untoward incident reported by the patient.
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Assessment method [3]
308233
0
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Timepoint [3]
308233
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i) Immediately prior to, during and immediately following application of NIRL.
ii) During, immediately following and 15 minutes post application of NIRL.
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Secondary outcome [1]
349811
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Change in maximum cystometric capacity.
Maximum cystometric capacity refers to the volume (in millilitres) that the bladder muscle can tolerate before the participant experiences a strong, uncontrollable desire to urinate.
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Assessment method [1]
349811
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Timepoint [1]
349811
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First and second cystometric fills; the latter being with NIRL insitu.
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Secondary outcome [2]
369083
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Change in bladder volume at strong desire to void.
Bladder volume refers to the millilitres of saline instilled into the bladder during cystometric filling. Strong desire to void is the point during cystometric filling at which the patient reports a strong sensation of the need to void.
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Assessment method [2]
369083
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Timepoint [2]
369083
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First and second cystometric fills; the latter being with NIRL insitu.
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Eligibility
Key inclusion criteria
• Greater than or equal to 20 years of age
• Attending a urodynamic investigation for symptoms that include OAB
• Able to provide informed consent
• Able and willing to participate in the study tasks
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Minimum age
20
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
• Demonstrate bladder outlet obstruction on first fill UD
• Have high / untreated blood pressure i.e. systolic >150mmHg or diastolic >100mmHg
at baseline measure
• Have cognitive impairment that requires care by another person
• Are unable to communicate in English without the service of an interpreter
• Have moderate to severe voiding dysfunction on first UD void
• Are unable to wear the study nasal prong
• Have serious medical conditions including malignancies, psychiatric, behavioural or
drug-dependency problems, which are likely to influence the participant’s ability to
cooperate
• Are participating in any other therapeutic trial
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
Safety, feasibility and proof of concept study.
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Continuous variables will be summarised using mean (SD) or median (IQR) and categorical variables summarised with frequencies and percentages. Given the small sample size, median differences in the four endpoints of interest pre and post NIRL will be calculated using the Wilcoxon Signed Rank Test and 95% confidence intervals presented, A two-sided alpha significance level of 0.05 will be used as the cut point for statistical significance.
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Recruitment
Recruitment status
Completed
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Date of first participant enrolment
Anticipated
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Actual
12/02/2019
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Date of last participant enrolment
Anticipated
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Actual
21/02/2019
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Date of last data collection
Anticipated
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Actual
21/02/2019
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Sample size
Target
10
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Accrual to date
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Final
10
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
11483
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Royal Melbourne Hospital - Royal Park campus - Parkville
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Recruitment postcode(s) [1]
23503
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3052 - Parkville
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Funding & Sponsors
Funding source category [1]
300201
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Hospital
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Name [1]
300201
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Melbourne Health
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Address [1]
300201
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34-54 Poplar Rd
Parkville
VICTORIA 3052
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Country [1]
300201
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Australia
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Primary sponsor type
Hospital
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Name
Melbourne Health
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Address
34-54 Poplar Rd
Parkville
VICTORIA 3052
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Country
Australia
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Secondary sponsor category [1]
299608
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None
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Name [1]
299608
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Address [1]
299608
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Country [1]
299608
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
301027
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Melbourne Health Human Research Ethics Committee
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Ethics committee address [1]
301027
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34-54 Poplar Rd
Parkville
VICTORIA 3052
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Ethics committee country [1]
301027
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Australia
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Date submitted for ethics approval [1]
301027
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25/07/2018
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Approval date [1]
301027
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15/10/2018
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Ethics approval number [1]
301027
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Summary
Brief summary
Overactive bladder is a term describing the clinical problem of urinary urgency +/-urgency incontinence. It is a bothersome condition that occurs equally in men and women. OAB places a burden on both the individual and the healthcare system. It is associated with reduced quality of life, increased risk of falls, high healthcare utilisation, personal cost and lower work productivity.
This research study is the first part of a two-part study that aims to establish whether intervention with Near Infrared Red Light therapy delivered via a nasal prong can help to reduce the symptoms of overactive bladder. It is hoped that this research will lead to a more effective and standardised treatment plan for people with overactive bladder.
The research intervention (Near Infrared Light) has successfully been used for other conditions where people are in pain.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
85638
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A/Prof Wendy Bower
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Address
85638
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The Royal Melbourne Hospital
34-54 Poplar Rd
Parkville
VICTORIA 3052
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Country
85638
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Australia
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Phone
85638
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+61 3 8387 2211
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Fax
85638
0
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Email
85638
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[email protected]
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Contact person for public queries
Name
85639
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A/Prof Wendy Bower
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Address
85639
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The Royal Melbourne Hospital
34-54 Poplar Rd
Parkville
VICTORIA 3052
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Country
85639
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Australia
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Phone
85639
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+61 3 8387 2211
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Fax
85639
0
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Email
85639
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[email protected]
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Contact person for scientific queries
Name
85640
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A/Prof Wendy Bower
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Address
85640
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The Royal Melbourne Hospital
34-54 Poplar Rd
Parkville
VICTORIA 3052
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Country
85640
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Australia
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Phone
85640
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+61 3 8387 2211
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Fax
85640
0
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Email
85640
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
458
Ethical approval
375645-(Uploaded-23-11-2018-13-43-43)-Study-related document.pdf
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF