Electronic Urinary flowmeter to improve accuracy of bladder diaries
Research type
Research Study
Full title
A prospective study looking at improving diagnostic capability of bladder diaries by improving accuracy of voided volume, measured by a self-administered automatic measuring vessel, in an ambulatory setting, in adult women with lower urinary tract symptoms.
IRAS ID
296904
Contact name
Ilias Liapis
Contact email
Sponsor organisation
Birmingham Women`s and Children`s NHS Foundations Trus
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 5 months, 1 days
Research summary
This study is part of a research project looking at improving accuracy and increasing the utility of bladder diaries, which form one of the most basic first line investigations in females with lower urinary tract symptoms (LUTS). It is a single centre, prospective, interventional study which will offer a vessel for automated measurement of voided volumes of urine. The accuracy of bladder diaries generated by the automated measurement will then be compared to the bladder diaries generated by the conventional eyeballing estimate method of measuring voided volumes.The participants will be blinded to the automated vessel measurements.
Lower urinary tract symptoms (LUTS) are prevalent and occur in 52-60% of women . Despite “bladder diaries” being an established first line investigation of LUTS and endorsed by NICE they are seldom used properly. Factors affecting the accuracy of bladder diaries include their format (paper vs electronic) and accuracy of the estimation of the voided volumes recorded.
Current standard practice for estimating voided urine volumes for bladder diaries rely on patient eye-ball estimates. Women with lower urinary tract symptoms are more likely to have smaller voids, as such the error in estimation may become more significant as the error is relatively larger compared to the voided volume compounding its effect. Current estimates, suggest errors of 10% against an agreed international standard of physiological measurement of 3%. The advantages of automation of measurement of voided urine volume include simplicity of use and thus increased compliance as well as elimination of error of measurement. As such the utility and diagnostic functionality of test should improve with the use of more accurate data resulting in reduced need for second line investigations making the service more efficient and cost effective.
Eligible participants include female adults presenting with LUTS in the Urogynaecology clinic in Birmingham Women’s Hospital.
The study is expected to last for two years and the participants would be asked to void for a consecutive 3 day period as a one off event to the diary pod provided to produce an electronic bladder diary whilst at the same time completing a paper bladder diary.
REC name
East Midlands - Derby Research Ethics Committee
REC reference
22/EM/0152
Date of REC Opinion
20 Jul 2022
REC opinion
Further Information Favourable Opinion