Nocturia, take three: The field study

A trial study of an advance in the treatment of nocturia published in New Zealand Doctor (“Nocturia, take three – to pee or not to pee”, 22 June) concluded, “My n-of-1 trial may grow into something bigger. And a good night’s sleep will improve the lives of other old guys.”

This second study begins that growth into something bigger. It was conducted by Jules Older and, with the help of colleagues, analysed by Bruce Arroll.

A population-based study in Finland concluded that “At least two voids per night is associated with impaired health-related quality of life. The majority of people report having bother when the number of nocturia episodes is two, and moderate or major bother when the number is three or more. One void per night does not identify subjects with interference from nocturia and, thus, is not a suitable criterion for clinically relevant nocturia.”¹

Nocturia is usually associated with benign prostatic hyperplasia in older men, and most nocturia treatments aim at managing this condition.

The normal prostate reaches 20±6g in men aged between 21 and 30, and this weight remains constant with age unless benign prostatic hyperplasia develops.

The prevalence of pathological benign prostatic hyperplasia is only 8 per cent in the fourth decade; however, 50 per cent of the male population has pathological benign prostatic hyperplasia when they are aged 51 to 60.² By age 80, that number climbs to roughly 90 per cent.³

For treatment, the available range of medications includes alpha-1 blockers, 5-alpha-reductase inhibitors, anticholinergics and phosphodiesterase-5 inhibitors. However, these medications do not work for all patients, and all come with common and occasionally severe adverse effects.

A behavioural treatment would have major advantages, particularly if it did not require a major behaviour change. Dr Older came up with the idea of night-time re-micturition, which he named “Nocturia, take three”. It involves urinating, distracting oneself for three or more minutes, then urinating again. When trying this himself, instead of going back to bed only to have the urge to urinate wake him again 10 minutes later, he found he could return to slumber for more hours of restful sleep.

The clinical question was: would this intervention reduce subsequent micturitions in a group of men blinded to the study hypothesis? The methods we employed to test this question are as follows.

This study had a before-and-after, individual-patient design. The participants were chosen from men over the age of 65 who were friends and acquaintances of Dr Older. They were not selected because of issues with nocturia – it was assumed they were likely to have nocturia issues based on their age alone.

Each volunteer was instructed to record the number of nightly micturitions for seven days and to email the data to the principal investigator. Details of the intervention were then supplied.

The intervention required participants who woke during the night to micturate, wait for three minutes (the “take three” instruction), then re-micturate. An additional seven days of data were collected, with participants completing the behavioural intervention upon waking at night to pass urine.

There was no randomisation in this study – all participants were included and received the intervention. Study participants were kept blind to the intervention until after they had emailed the results of their baseline micturitions.

The statistical methods chosen were a paired t-test on the number of micturitions before and after the intervention. The sample size was not determined before the study, but using a paired analysis meant that, if effective, a large sample would not be needed.

Ethics approval was not obtained for this project. This paper was written according to the CONSORT (CONsolidated Standards of Reporting Trials) 2010 checklist for reporting within-person randomised trials (although this study was not randomised).⁴

It is not medication based, requires no surgical intervention and, other than responding to emails in the middle of the night, seems to have no adverse effects

Eight men were recruited, enrolled in the study, and completed the study. Their ages ranged from 67 to 91.

One participant increased his micturitions, and another had no change. The other six participants had fewer micturitions. The average number of micturitions before the intervention was 13.9, and after it was 10.8 (see table). A t-test using SAS analytics found a significant result – paired t-test one-tail p-value = 0.025.

There were no reported harms other than one of the participants checking his emails on his phone. He was annoyed at a particular email and wrote an angry, middle-of-the-night response, which he later regretted. The participants have maintained cordial relationships with the principal investigator.

The findings of this small pilot study suggest that “Nocturia, take three” may be an effective intervention for nocturia. This could be an essential tool in the primary care toolkit as it is not medication based, requires no surgical intervention and, other than responding to emails in the middle of the night, seems to have no adverse effects.

The limitation of this trial is its small sample size and use of a convenience sample of acquaintances. Possible sources of bias include incomplete emptying at the baseline micturition due to the desire to return quickly to bed in the middle of the night.

This project’s results are promising and warrant a large, parallel, randomised controlled trial. We would advise future investigators in the subsequent study to discourage responding to late-night emails.

Results were sent to participants after taking part. We will share our results with the wider community through social media channels, educational meetings and press release.

Jules Older, PhD, has previously designed a behavioural science course, taught medical students about human behaviour, and teaches aspiring writers (www.julesolder. com). Bruce Arroll is a specialist GP in Manurewa and a professor of general practice and primary health care at the University of Auckland