Comparing the usability of bladder diaries
Research type
Research Study
Full title
Comparing the usability of an electronic bladder diary and a paper bladder diary: a two-way crossover study
IRAS ID
207899
Contact name
Richard Inman
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS FT
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 11 months, 17 days
Research summary
This piece of research is a single centre, two-way cross over, prospective study to compare the outcomes and experience of patients completing a paper bladder diary and an electronic version. This project aims to examine whether an electronic bladder diary can improve data quality compared to a paper bladder diary. Participants will attend an introduction appointment within the Urology Department at Royal Hallamshire Hospital. The participant will complete the bladder diaries at home and will then complete a questionnaire at the Royal Hallamshire Hospital. All patients will be attending for video or standard urodynamic (pressure-flow study) testing. Patients who are being sent an appointment for urodynamics (standard or video) will also be sent a recruitment letter and participant information sheet (PIS), to inform them of the study. The recruitment letter will include a reply slip. The reply slip will be sent back by individuals who are interested in participating in the study. Once a favourable response has been received and as long as they fulfil the inclusion/exclusion criteria they will be invited to attend an introduction appointment. Alternatively potential participants can contact the research team directly using the telephone contact details which are on the recruitment letter and participant information sheet. Potential participants who telephone the research team with an interest in participating will be invited to attend the introduction appointment. This method of recruitment will ensure that participants have full ability to opt-in. The introductory appointment will be conducted 1-2 weeks prior to the urodynamic test, at which point study details will be discussed and written informed consent will be taken. The participant will be taught how to use the digital and paper versions of the bladder diaries. Participants will be asked to complete the electronic diary for three days and the paper diary for three days. Half of the participants will complete the digital diary first, the other half will complete the paper diary first, and this will be done by alternating consecutively. Patients will be asked to record the time and volume of voids, any incontinence or urgency episodes and sleep-wake times. On the day of their urodynamics appointment, patients should return with their electronic and paper diaries.
REC name
North of Scotland Research Ethics Committee 2
REC reference
16/NS/0056
Date of REC Opinion
16 Jun 2016
REC opinion
Further Information Favourable Opinion