None listed
Conditions
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.
Interventions
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
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
Sponsors
Nathan Lawrentschuk
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
- >18 years old - non-pregnant - patients being investigated for lower urinary tract symptoms
Exclusion criteria
Non-english speaking background Pregnant females Healthy participants
Outcome results
None listed