Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000109303p
Ethics application status
Submitted, not yet approved
Date submitted
12/01/2017
Date registered
20/01/2017
Date last updated
20/01/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Does using an automated bladder diary improve compliance and data accuracy in patient completing a bladder diary?
Scientific title
Does a fully automated bladder diary improve patient compliance and data accuracy in patients performing a bladder diary for investigation of their lower urinary tract symptoms?
Secondary ID [1] 290902 0
None
Universal Trial Number (UTN)
U1111-1191-5286
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Overactive Bladder 301621 0
Lower Urinary Tract Symptoms 301622 0
Nocturia 301623 0
Condition category
Condition code
Renal and Urogenital 301329 301329 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Automated Bladder Diary

- Participants will be asked to use a portable automated device to measure their urine over a 3 day period in addition to the usual practice of manual measuring of urine to help assess volumes passed by the patient
- The device is called "iUFlow" and is manufactured by Kesem Health Pty Ltd.
- The aim is to assess whether the use of this device provides superior results compared to patient manual measurement and paper documentation of urine volumes
- The iUFlow device is placed over the toilet bowl and collects urine as the patient voids. This is linked to a smartphone application that each patient downloads free of charge
- The application tallies the total volumes of the urine and the patient is asked to provide a rating for each void of their urgency (how pressured they felt to urinate) and incontinence (any involuntary leakage of urine that occurred)
- The intervention is the use of this device
- All patients will be using the device
- The patient will be using this device i.e. performing their own intervention
- Instructions on device use are brief and mainly relate to activation of the device. A brief instructional video is available on youtube: https://youtu.be/WHT7fRK67_A
- assessment of patients will take place by a consultant urologist
- no medical decisions will be made based on the outcome of the patients collected data from the device
- intervention will be delivered individually
- intervention will take place in the patients home as an ambulant study as this device is designed to replace a process that takes place in the patients home
- The intervention will take place over 3 days (standard length of time for bladder diary) and will only occur once. Patients will be asked to use the device continuously for 72 hours. Dose and intensity not applicable to this study
- Participants will be assigned to 2 groups through the use of random allocation of white unmarked envelopes to decide which diary type they will perform first
- Group 1 will perform the automated diary first followed by the paper diary, group 2 will perform the paper diary first followed by the automated diary.
- The 2 diaries will preferably be performed over 6 consecutive days
- No changes have been made to the design
- Adherence and fidelity to the intervention are measured outcomes of the intervention itself, so no measures were made to improved compliance as this is an outcome measure testing the effect of the device
Intervention code [1] 296848 0
Diagnosis / Prognosis
Comparator / control treatment
- All patient will complete a "traditional" paper voiding diary. This involves patients collecting their urine with each void in a measuring jug and recording the amounts of urine they pass. This amount is recorded in a "diary" and with each voiding event, the patient also writes down if they had any incontinence or if they felt a very strong urge to urinate. The volumes tallied are added up at the end of the day to assess the pattern of voiding.
Control group
Active

Outcomes
Primary outcome [1] 300731 0
- Compliance with data entry will be assesed by patient survey
- Patients will be asked how many times they went to the toilet and failed to record their urine volumes for each of the diary types. This will be a measure of "compliance" with diary procedures
- Data provided by the automated bladder diary of patients will not be used to make decisions for health care
Timepoint [1] 300731 0
72hours
Secondary outcome [1] 330735 0
- Preference of Automated Diary Compared to Traditional paper diary
- This will be assesed by survey and direct input by patients who will have a chance to explain their preference for paper vs. device use
Timepoint [1] 330735 0
end of study (7 days)
Secondary outcome [2] 330821 0
Ease of use of the device
- assessed through survey assessing patient rating of ease of use
Timepoint [2] 330821 0
7 days (end of trial)
Secondary outcome [3] 330823 0
Time taken to perform diary
Timepoint [3] 330823 0
Assessed by patient report at survey point at days 3 and 6

Eligibility
Key inclusion criteria
- >18 years old
- non-pregnant
- patients being investigated for lower urinary tract symptoms
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Non-english speaking background
Pregnant females
Healthy participants

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled 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)
Simple randomisation using procedures like coin-tossing and dice-rolling
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
- In this study participants will perform both diary types
- This study will involve half of the recruited patients completing the traditional paper diary first followed by the automated diary, with the other half of the cohort beginning with the automated diary and completing the paper diary second.
- This will be done to combat any bias in results from learned experience (getting used to doing a diary so becoming better at it) and from "diary fatigue" (becoming less compliant with completing a diary due to the length of time of effort)
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Previous research in a healthy volunteer population has shown the mean reduction of missedurinary data input events to be 2.5 for the traditional diary group and 1.1 for the device group with a standard deviation of 2 in each group. This is expected to increase based on an inflation factor of 50% in a patient population due to increased pathology. Power calculations were performed using Stata v.12.0SE (College Station, TX, USA) and showed analysis was conducted based upon an independent samples t-test, assuming statistical power of 0.80 and an alpha value of 0.05. Calculations lead to approximately 11 patients in each arm of the group. To allow for 4 patients from each arm of the study not completing or withdrawing from the study we aim to recruit 15 patients for each arm, 30 patients in total.
It is feasible that approximately 4 patients would be able to be recruited each week so an
expected recruitment period of 7-8 weeks is the aim.

Data will be entered in an Excel 2016 spread sheet (Microsoft, Redmond, CA, USA). Analysis will be performed using Stata v.12.0SE (College Station, TX, USA). Data will be defined as categorical or continuous. Distribution of continuous data will be assessed and deemed parametric or nonparametric. Categorical data will be analysed using Fishers' exact or Chi Square as appropriate. Parametric continuous data will be analysed using an independent t test or one-way ANOVA. Non-parametric continuous data will be assessed using Mann-Whitney U test or Kruskal Wallis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/02/2017
Actual
Date of last participant enrolment
Anticipated
15/08/2017
Actual
Date of last data collection
Anticipated
30/08/2017
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 7276 0
Epworth Cliveden - Melbourne East
Recruitment hospital [2] 7277 0
Epworth Eastern Hospital - Box Hill
Recruitment hospital [3] 7278 0
Epworth Freemasons - Melbourne
Recruitment postcode(s) [1] 15046 0
3002 - Melbourne
Recruitment postcode(s) [2] 15044 0
3002 - Melbourne East
Recruitment postcode(s) [3] 15045 0
3128 - Box Hill

Funding & Sponsors
Funding source category [1] 295326 0
Commercial sector/Industry
Name [1] 295326 0
Kesem Health PTY PTD
Country [1] 295326 0
Australia
Primary sponsor type
Individual
Name
Nathan Lawrentschuk
Address
Austin Health
145 Studley Rd.
Heidelberg, VIC 3084
Country
Australia
Secondary sponsor category [1] 294150 0
None
Name [1] 294150 0
Address [1] 294150 0
Country [1] 294150 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 296663 0
Epworth Healthcare HREC
Ethics committee address [1] 296663 0
89 Bridge Road, Richmond VIC 3121
Ethics committee country [1] 296663 0
Australia
Date submitted for ethics approval [1] 296663 0
18/01/2017
Approval date [1] 296663 0
Ethics approval number [1] 296663 0

Summary
Brief summary
Voiding diaries are essential in the effective evaluation of males and females with lower
urinary tract symptoms (LUTS). Since their initial use more than 50 years ago, voiding
diaries have helped to contribute to the diagnosis and appropriate management of many
patients suffering from functional urological issues. The evolution of the bladder diary over
time has led to multiple formats and alterations tailored to suit differing clinical need.
Although there is no accepted scoring system for urgency, incontinence and patient
validation, the bladder diary is still currently the recommended and most accurate method of collecting voiding data. Despite this, these dairies are frequently tedious and time-consuming and are fraught with erroneous results due to a lack of patient compliance and accuracy of data collected.
With the recent utilization of e-health devices and technology in both society and
clinical practice, electronic voiding diaries have been introduced. These electronic diaries
offer advantages over traditional paper diaries that result in improved data quality and
increased patient compliance. However, current electronic diaries still depend on patient
handling and measurement of urine and manual input of voiding data into devices. This
remains burdensome and is a potential additive factor to inaccurately recorded volumes,
incomplete data collection and potential misdiagnosis.
The use of a fully automated voiding diary has definite potential advantages. By
eliminating urine handling and automating measurement, it reduces the burden to patients,
adds to accuracy of measured volumes and facilitates immediate and precise data entry.
This may benefit clinicians by providing more detailed, easy to interpret results and
ultimately improve clinical outcomes for the patient. The iUFlow (Kesem Health, Melbourne, Australia) device is one such example of an automated voiding diary.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 71678 0
Prof Nathan Lawrentschuk
Address 71678 0
Austin Health
145 Studley Rd.
Heidelberg 3084, VIC
Country 71678 0
Australia
Phone 71678 0
+61 3 94965000
Fax 71678 0
Email 71678 0
lawrentschuk@gmail.com
Contact person for public queries
Name 71679 0
Dr Daniel Christidis
Address 71679 0
Austin Health
145 Studley Rd.
Heidelberg 3084, VIC
Country 71679 0
Australia
Phone 71679 0
+61 3 94965853
Fax 71679 0
Email 71679 0
daniel.christidis@austin.org.au
Contact person for scientific queries
Name 71680 0
Dr Daniel Christidis
Address 71680 0
Austin Health
145 Studley Rd.
Heidelberg 3084, VIC
Country 71680 0
Australia
Phone 71680 0
+61 3 94965853
Fax 71680 0
Email 71680 0
daniel.christidis@austin.org.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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