This was a prospective study, approved by the institutional ethics committee. Inclusion criteria: Adult patients (≥18 years of age) attending the urology outpatient, who as part of their evaluation needed to make a frequency volume chart but were illiterate or not sufficiently literate to make a written record. Exclusion criteria: Patients who refused to give an informed consent, or those in whom an informed consent could not be taken.
Three group of people were involved in the study: i) Patient himself, ii) Nursing staff and iii) The Investigator/ Co-investigator, with each having their role clearly defined.
All eligible patients were admitted for 1 ½ days starting the evening prior to the day when the 24-hour FVC was to be made. On admission, the patient received - a) Two measuring jars (one smaller and one larger), b) A box of pebbles, c) 2 small cloth pouches, one yellow colored and the other black colored, d) A black marking pen.
The Investigator/Coinvestigator briefed the patient regarding the following:
The patient was told that he/she has to discard the first morning sample of urine. Thereafter, every time the patient voids till the next morning (1st sample of next morning to be included), he/she will void into the smaller measuring jar. The patient will mark the upper limit of urine level in smaller measuring jar after the first void. He/she will again mark the upper limit of urine level in the smaller measuring jar, if the level is higher than the earlier marked level at any subsequent void. Each time the patient voids, he/she will inform the nursing staff who will come, inspect the smaller measuring jar containing urine and then leave. After the nursing staff leaves, the patient was told to transfer the urine from the smaller measuring jar into the larger measuring jar. The patient was instructed that each time he/she voids during the daytime, he/she will put one pebble from the box into the yellow pouch. Before going to bed at night, the patient will mark on the large measuring jar (a horizontal line), the level till which it is filled with urine and also informs the nursing staff that he is going to bed. The patient was instructed that after sleeping, each time patient gets up from sleep to void, he/she shall continue to follow the protocol he/she had been following right through the day except that for each of these voids, one pebble from the box will be put into the black cloth pouch instead of the yellow cloth pouch. For the 1st morning void of the following morning, he/she shall put the pebble in the yellow pouch. Once the first morning void was transferred to the larger measuring jar, the patient was instructed to mark on the large measuring jar (a horizontal line), the level till which it is filled with urine. Thereafter he/she was asked to empty the large measuring jar and return the jars and the cloths to the investigator/co-investigator.
Nursing staff: The nursing staff was instructed to note the time and amount of urine patient passes each time. They were also instructed to note down the time the patient goes to sleep and the time he/she gets up in the morning.
Investigator/Coinvestigator: i) to brief the nursing staff and patients separately about their roles. ii) Once the jars and clothes are returned the investigator/co-investigator noted a) 24 hours’ urine production, b) Daytime urine volume, c) Nocturnal urine volume, d) Daytime urinary frequency, e) Nocturia, f) Average voided volume and g) Maximum voided volume
The patient reported (Investigator/Coinvestigator interpreted) data were compared with the data recorded by the nursing staff to see if this is a reliable method of extracting information as provided by the frequency volume chart