Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619001012167
Ethics application status
Approved
Date submitted
7/07/2019
Date registered
15/07/2019
Date last updated
15/07/2019
Date data sharing statement initially provided
15/07/2019
Type of registration
Prospectively 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 2..
Secondary ID [1] 298083 0
Nil known.
Universal Trial Number (UTN)
U1111-1217-8587
Trial acronym
The ROSE Study Part 2
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overactive Bladder 312596 0
Condition category
Condition code
Renal and Urogenital 311103 311103 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Near infrared light (NIRL), using a Vielight 810nm device, will be delivered to participants through a diode placed in their nasal cavity for 25 minutes, 5 times per week for 4 weeks; i.e. 20 sessions in total. The first session will be undertaken in the Urology Outpatient Clinic; thereafter 1 session per week will be delivered by the Study Research Assistant in the participant's home and the other 4 sessions per week self-administered by the participant. Monitoring of adherence to the intervention will be by way of a daily participant diary, weekly research assistant visit and weekly phone call to the participant.
Intervention code [1] 314314 0
Treatment: Devices
Comparator / control treatment
No control group.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 319882 0
Change in Overactive Bladder Symptom Score (OABSS).
The OABSS is a validated, patient-completed sum score of four symptoms (daytime frequency, night time frequency, urgency, and urgency incontinence) seen in patients with OAB, that has been shown to be sensitive to change after treatment.
Timepoint [1] 319882 0
Immediately after 4-week NIRL intervention.
Primary outcome [2] 319883 0
Change in daytime urinary frequency.
Urinary frequency will be recorded with the assistance of the "time stamp" function on the wrist-worn Actiwatch Spectrum Pro actigraphy device. Participants will be asked to press the button on the device each time they void on 2 days each week for the duration of the study.
Timepoint [2] 319883 0
Immediately after 4-week NIRL intervention.
Secondary outcome [1] 369779 0
Change in International Consultation on Incontinence Questionnaire: Overactive Bladder Quality of Life Module (ICIQ-OABqol) score.
Timepoint [1] 369779 0
Immediately after 4-week NIRL intervention.
Secondary outcome [2] 369780 0
Change in Overactive Bladder Symptom Score (OABSS).
Timepoint [2] 369780 0
4 weeks post NIRL intervention completion.
Secondary outcome [3] 369782 0
Change in daytime urinary frequency.
Urinary frequency will be recorded with the assistance of the "time stamp" function on the wrist-worn Actiwatch Spectrum Pro actigraphy device. Participants will be asked to press the button on the device each time they void on 2 days each week for the duration of the study.
Timepoint [3] 369782 0
4-weeks post NIRL intervention completion.
Secondary outcome [4] 369783 0
Change in International Consultation on Incontinence Questionnaire: Overactive Bladder Quality of Life Module (ICIQ-OABqol).
Timepoint [4] 369783 0
4-weeks post NIRL intervention completion.
Secondary outcome [5] 369784 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 or untoward incident reported by the patient.
Timepoint [5] 369784 0
i) Immediately prior to, during and immediately following application of NIRL (during sessions delivered by Study Research Assistant).
ii) During, immediately folllowing or post NIRL session.

Eligibility
Key inclusion criteria
• >=20 years of age
• Attending the outpatient continence service for help to manage urinary urgency ±
urgency incontinence; not necessarily treatment naive
• Able to provide informed consent
• Able and willing to participate in the study tasks
Minimum age
20 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Known bladder outlet obstruction, moderate to severe voiding dysfunction or
significant cystocele
• High or untreated blood pressure i.e. systolic >150mmHg or diastolic >100mmHg at
baseline measure
• Cognitive impairment that requires care by another person
• Are unable to communicate in English without the service of an interpreter
• Serious medical conditions which are likely to influence their ability to cooperate
• Participating in any other therapeutic trial
• Are starting a new intervention for OAB at the time of the study

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)
Not applicable.
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
Single group
Other design features
This study will utilise a single-case experimental design (SCED) to enable testing of the efficacy of a novel intervention in a small group of OAB patients with heterogeneous symptoms. This design relies on frequent and repeated measures throughout the baseline, intervention and follow-up phases. Specifically, a non-concurrent, multiple baseline, across-subjects format has been chosen because maintenance of the effect of NIRL intervention is both plausible and desirable.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
The demographic and clinical characteristics of the participants will be tabled following standard procedure. Appropriate graphical technique(s) will be used to explore the longitudinal changes in both the OABSS and Actiwatch urinary frequency at individual participant level. This presentation will depict both within-phase and between-phase comparisons. If the above analyses indicate any pattern, further simulation-based analyses will be conducted as appropriate.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/08/2019
Actual
Date of last participant enrolment
Anticipated
31/01/2020
Actual
Date of last data collection
Anticipated
31/03/2020
Actual
Sample size
Target
6
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 13662 0
Royal Melbourne Hospital - Royal Park campus - Parkville
Recruitment postcode(s) [1] 26344 0
3052 - Parkville

Funding & Sponsors
Funding source category [1] 302614 0
Hospital
Name [1] 302614 0
Melbourne Health
Country [1] 302614 0
Australia
Primary sponsor type
Hospital
Name
Melbourne Health
Address
34-54 Poplar Road
Parkville
VICTORIA 3052
Country
Australia
Secondary sponsor category [1] 303296 0
None
Name [1] 303296 0
Address [1] 303296 0
Country [1] 303296 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303248 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 303248 0
Ethics committee country [1] 303248 0
Australia
Date submitted for ethics approval [1] 303248 0
29/04/2019
Approval date [1] 303248 0
31/05/2019
Ethics approval number [1] 303248 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 93002 0
A/Prof Wendy Bower
Address 93002 0
The Royal Melbourne Hospital
34-54 Poplar Rd
Parkville
VICTORIA 3052
Country 93002 0
Australia
Phone 93002 0
+61 3 8387 2211
Fax 93002 0
Email 93002 0
[email protected]
Contact person for public queries
Name 93003 0
Wendy Bower
Address 93003 0
The Royal Melbourne Hospital
34-54 Poplar Rd
Parkville
VICTORIA 3052
Country 93003 0
Australia
Phone 93003 0
+61 3 8387 2211
Fax 93003 0
Email 93003 0
[email protected]
Contact person for scientific queries
Name 93004 0
Wendy Bower
Address 93004 0
The Royal Melbourne Hospital
34-54 Poplar Rd
Parkville
VICTORIA 3052
Country 93004 0
Australia
Phone 93004 0
+61 3 8387 2211
Fax 93004 0
Email 93004 0
[email protected]

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?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
1954Ethical approval    377486-(Uploaded-07-07-2019-17-27-36)-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.