Hypothesis / aims of study
Nocturia is defined by the International Continence Society as ‘the complaint that the individual has to wake at night one or more times to void.’ Several analyses have linked nocturia to both short-term and lifelong health consequences, including hypertension, congestive heart failure and disruptive mental and physical well-being. There is a relative paucity of data as it relates to sleep quality, daily activity impairment, and work productivity loss associated with nocturia diagnosis in LUTS in the US. This study aimed to examine the importance of providing accurate nocturia diagnosis in the absence or presence of overactive bladder or benign prostatic hyperplasia, commonly referred to as LUTS.
Study design, materials and methods
Analysis was based on the Adelphi Lower Urinary Tract Symptoms Disease Specific Programme, a point-in-time survey of physicians and consulting patients conducted in 2013. Urologists, Gynecologists, and Primary care physicians in the US, completed patient record forms for the next 14 patients, detailing patient demographics and diagnoses including OAB, BPH and nocturia, or combinations. Patients were invited to complete a separate patient self-completion form (PSC) which included mean number of night-time voids over the last week, length of first undisturbed sleep period before voiding, frequency of feeling tired during the day, mean number of daytime naps (over 5 minutes) taken over the last week, degree of bother over disturbed sleep, frequency of sleep disturbance impacting partner, and validated patient-reported outcomes including the Overactive Bladder Questionnaire (OAB-q), the Nocturia Impact (NI) Diary and the Work Productivity and Activity Impairment (WPAI) questionnaire. Patients were stratified into two groups based on the presence/absence of a nocturia diagnosis as deemed by the physician. Mann-Whitney U and Fisher’s Exact tests were performed to assess significance between patient groups. Analysis were restricted to those patients who completed a PSC. All tests were two-sided with a significance p-value of 0.05.
In total, 148 physicians provided data on 2086 LUTS patients, of which 702 (334 PSCs) had a diagnosis of nocturia and 1367 (776 PSCs) had no diagnosis of nocturia. The two patient groups were comparable as measured by age, gender, and body mass index. Median age of patients completing a PSC (1110) was 65.0 years, and 54% were male. Compared with patients without nocturia, those with a nocturia diagnosis reported a significantly higher mean number of night-time voids (3.0 versus 2.1; p<0.0001) and significantly more naps taken during the day (mean 0.8 versus 0.7; p=0.0343). A larger proportion of nocturia patients reported waking after less than 3 hours’ sleep to urinate (86% versus 74%; p=0.0002), feeling tired during the day (62% versus 43%; p<0.0001) and being bothered by their nighttime urination (bothered = “quite a bit” or “a great deal” or “a very great deal”; 49% versus 21%, p<0.0001). In addition, patients with a nocturia diagnosis reported worse symptom severity as measured by the OAB-q Symptom Severity Questionnaire (mean 36.2 versus 27.1; p<0.0001) and health-related quality of life as measured by the OAB-q Total HRQL Score (mean 66.9 versus 75.2; p<0.0001). Patients also reported lower scores on daily activity as measured by NI Diary (mean 33.6 versus 24.8; p<0.0001) and total impact (mean 41.6 versus 25.9; p<0.0001) on the NI Diary Q-12 and higher levels of overall work impairment (mean 28.2 versus 20.6; p=0.0048) and activity impairment (mean 33.9 versus 26.5; p<0.0001) as measured by the Work Productivity and Activity Impairment Index.
Interpretation of results
A significant portion of LUTS patients in the US also suffer from nocturia. Furthermore, these data suggest a link between nocturia diagnosis in US LUTS patients to sleep disturbances, disruption of daily activities, work productivity and activity impairment, as well as quality of life.