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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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.
Scientific title
An evaluation of the safety and efficacy of photobiomodulation on symptoms of an overactive bladder. Part 1.
Secondary ID [1] 295621 0
Nil known
Universal Trial Number (UTN)
U1111-1217-8587
Trial acronym
The ROSE Study Part 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overactive Bladder 308950 0
Condition category
Condition code
Renal and Urogenital 307847 307847 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 301926 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 306824 0
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.
Timepoint [1] 306824 0
First and second cystometric fills; the latter being with NIRL insitu.
Primary outcome [2] 308232 0
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.
Timepoint [2] 308232 0
First and second cystometric fills; the latter being with NIRL insitu.
Primary outcome [3] 308233 0
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.
Timepoint [3] 308233 0
i) Immediately prior to, during and immediately following application of NIRL.
ii) During, immediately following and 15 minutes post application of NIRL.
Secondary outcome [1] 349811 0
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.
Timepoint [1] 349811 0
First and second cystometric fills; the latter being with NIRL insitu.
Secondary outcome [2] 369083 0
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.
Timepoint [2] 369083 0
First and second cystometric fills; the latter being with NIRL insitu.

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
Minimum age
20 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Not applicable.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Safety, feasibility and proof of concept study.
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
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.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11483 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment postcode(s) [1] 23503 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 300201 0
Hospital
Name [1] 300201 0
Melbourne Health
Address [1] 300201 0
34-54 Poplar Rd
Parkville
VICTORIA 3052
Country [1] 300201 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
34-54 Poplar Rd
Parkville
VICTORIA 3052
Country
Australia
Secondary sponsor category [1] 299608 0
None
Name [1] 299608 0
Address [1] 299608 0
Country [1] 299608 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301027 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 301027 0
34-54 Poplar Rd
Parkville
VICTORIA 3052
Ethics committee country [1] 301027 0
Australia
Date submitted for ethics approval [1] 301027 0
25/07/2018
Approval date [1] 301027 0
15/10/2018
Ethics approval number [1] 301027 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 85638 0
A/Prof Wendy Bower
Address 85638 0
The Royal Melbourne Hospital
34-54 Poplar Rd
Parkville
VICTORIA 3052
Country 85638 0
Australia
Phone 85638 0
+61 3 8387 2211
Fax 85638 0
Email 85638 0
wendy.bower@mh.org.au
Contact person for public queries
Name 85639 0
A/Prof Wendy Bower
Address 85639 0
The Royal Melbourne Hospital
34-54 Poplar Rd
Parkville
VICTORIA 3052
Country 85639 0
Australia
Phone 85639 0
+61 3 8387 2211
Fax 85639 0
Email 85639 0
wendy.bower@mh.org.au
Contact person for scientific queries
Name 85640 0
A/Prof Wendy Bower
Address 85640 0
The Royal Melbourne Hospital
34-54 Poplar Rd
Parkville
VICTORIA 3052
Country 85640 0
Australia
Phone 85640 0
+61 3 8387 2211
Fax 85640 0
Email 85640 0
wendy.bower@mh.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
What supporting documents are/will be available?
Ethical approval
How or where can supporting documents be obtained?
Type [1] 458 0
Ethical approval
Citation [1] 458 0
Link [1] 458 0
Email [1] 458 0
Other [1] 458 0
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
No
Results – basic reporting
Results – plain English summary
Between 12/02/19 and 12/03/19, 19 patients from 6 urodynamic clinics were screened for eligibility. 10/19 patients (53%) met the eligibility criteria; 100% of eligible patients agreed to study participation.

The NIRL was applied for the duration of the 2nd urodynamic fill (8 to 20 minutes). No adverse events were reported. There were no statistically or clinically significant changes in systolic or diastolic blood pressure during the 2nd urodynamic fill with NIRL insitu.

In terms of urodynamic parameters, no statistically significant differences were identified between the 1st fill and 2nd fill for any of the study endpoints (detrusor pressure and bladder volume at 1st involuntary detrusor contraction; bladder volume at strong desire and maximum bladder volume achieved).