A recent population survey in Hong Kong showed that 68% of men and 67% of women aged >40 years seeking medical advice for lower urinary tract symptoms (LUTS) had ≥2 nocturia episodes/night1; these prevalences are greater than that among individuals of similar age reported in other global studies.2 Across urology clinics in Southeast Asian countries, nocturia has emerged as the most common presenting symptom (up to 88%) among men with LUTS requiring treatment3; however, at least half of these patients were dissatisfied with the results of treatment.4

Nocturia is no longer considered a distinct urologic disease.5 Indeed, it is related to disorders within and outside the lower urinary tract, which are associated with diminished bladder capacity, increased rate and volume of nocturnal urine production, sleep disturbance, or a combination of these symptoms.6 Thus, initial treatment is difficult and there is a need for a tool that captures relevant aetiological information earlier in the diagnostic pathway.

The short form of the Targeting the individual’s Aetiology of Nocturia to Guide Outcomes (TANGO) is a recently developed, 22-item, dichotomous-choice, multi-dimensional, self-administered questionnaire in English with robust psychometric properties.7 8 This questionnaire covers four thematic areas regarding aetiologies and co-morbidities related to nocturia: cardiovascular or metabolic disorders, sleep/nocturnal pain/apnoea variables, urinary tract symptoms, and mental health and well-being (including falls). This study was performed to translate and cross-culturally adapt the TANGO into Chinese, ie, to produce a Chinese version of the TANGO [TANGO (CV)], then evaluate its reliability and validity for use in Hong Kong.

We adopted the cross-cultural translation methodology described by Sperber9 and recommended by the original authors of the TANGO.7 Six independent bilingual translators were asked to produce six forward translations (in Chinese) of each item of the TANGO, with the goal of conceptual translation; all six forward translations were back-translated to English, yielding six back-translations.

The six back-translations (in English) were reviewed by a panel of urologists (n=4), urology nurse specialists (n=2), and staff without a medical background (n=2) who were not involved in conducting this study, to produce a preliminary draft of each item in the translated tool. Each item in the English back-translations was compared with the original English version by ranking in terms of language comparability and the interpretation similarity using a Likert scale from 1 (extremely comparable/similar) to 7 (not at all comparable/similar). Items from the back-translations with a mean score <2.50 were retained. The forward translations (Chinese) of the retained back-translated English items were reviewed and compared in a panel consensus meeting comprising four urologists, two urology nurse specialists, and two bilingual translators. These items were used to draft the final version of the translated tool, the TANGO (CV).

After linguistic translation, a prospective psychometric evaluation study was conducted. From December 2019 to March 2020, we recruited male and female patients aged 45 to 90 years who presented to the urology clinic for management of LUTS problems and with self-reported nocturia episodes of ≥2 per night as patient group. Exclusion criteria were a history of prostatic surgery and/or prostate cancer, as well as the presence of active urinary tract infection, active cancer receiving treatment, bladder stone, neuropathic bladder, dependent daily activities (including feeding, bathing, and walking with assistance), diabetes insipidus, renal failure, pregnancy, and/or illiteracy. Healthy individuals of similar age with self-reported nocturia episode of ≤1 per night were recruited as controls.

After recruitment, participants completed the TANGO (CV), the Chinese version of the International Prostate Symptom Score (IPSS),10 the International Consultation on Incontinence Questionnaire Nocturia module (ICIQ-N),11 the Nocturia-Specific Quality-of-Life Questionnaire (NQoL),12 the Hong Kong Chinese version of the Overactive Bladder Symptom Score (OABSS-HKC) questionnaire,13 the Epworth Sleepiness Scale (ESS),14 and the Chinese version of the STOP-Bang questionnaire.15 Participants underwent assessment of their histories of hypertension, diabetes mellitus, hyperlipidaemia, cerebrovascular accident, ischaemic heart disease, peripheral oedema, and obstructive sleep apnoea; their responses were cross-checked with the diagnostic codes of the central registry and their previous medical records. Blood glucose, glycated haemoglobin (HbA1c), and estimated glomerular filtration rate were measured. Participants were also given bladder/sleep diaries to record the time and volume of each voiding event, along with their sleep information (times of going to bed, falling asleep, awakening from sleep, and rising from bed), for 4 consecutive days at home within 2 weeks after recruitment. Participants then returned the bladder/sleep diaries to the clinic and repeated the TANGO (CV).

Reliability (inter-item correlation) was determined by internal consistency based on the Kuder–Richardson Formula 20 (KR-20) coefficient, which is specifically designed for dichotomous-choice questionnaires.16 Test-retest reliability was determined using Cohen’s kappa value (κ) and the intra-class correlation coefficient (ICC) by comparing the agreement of repeat responses for each item and the congruency of the number of positive responses to the tool between recruitment and follow-up (2 weeks later). κ≥0.4 and ICC ≥0.7 were considered acceptable reliability.17

We examined content validity by assessing the level of missing data, which indicated acceptability and difficulty in terms of participant understanding of items within the tool. Construct validity, which reflects the theory underlying nocturia, was evaluated by comparing the number of the positive responses to each of the four domains and all four domains of the TANGO (CV) with data regarding bladder/sleep diary–based parameters, as follows:

1. Cardiovascular/metabolic domain (Questions 1-7) was compared with the bladder diary (nocturia episodes, rate and volume of nocturnal urine output between falling asleep and awakening, and nocturnal polyuria index);
2. Sleep-related domain (Questions 8-13) was compared with the bladder diary [sleeping time, sleep latency, sleep quality, and degree of vitality after sleep, using a scale from 0 (the worst) to 10 (the best)];
3. LUTS domain (Questions 14-18) was compared with the bladder diary as in (1);
4. General well-being domain (Questions 19-22) was compared with the bladder diary as in (2);
5. The whole tool (all four domains, Questions 1-22) was compared with the abovementioned parameters.

Criterion validity was estimated by comparing the number of the positive responses to each of the four domains and all four domains with the responses to items on other questionnaires evaluating similar constructs, as follows:

1. Cardiovascular/metabolic domain was compared with ESS, STOP-Bang questionnaire, ICIQ-N-4(b) and NQoL sleep/energy domain, NQoL bother/concern domain, NQoL global QoL domain, and total score of NQoL;
2. Sleep-related domain was compared with ESS, STOP-Bang questionnaire, ICIQ-N-4(b), and NQoL;
3. LUTS domain was compared with IPSS voiding (sum of scores of Questions 1, 3, 5, and 6), IPSS storage (sum of scores of Questions 2, 4, and 7), ICIQ-N-4(b), OABSS (total), and NQoL;
4. General well-being domain was compared with IPSS QoL, NQoL sleep/energy domain, NQoL bother/concern domain, NQoL global QoL domain, and total score of NQoL.

We assumed that a correlation coefficient ρ≥0.4 was moderate and acceptable18 as evidence of construct/criterion validity.

For discriminant validity, receiver operating characteristic analysis, in combination with Youden’s J statistic [ie, sensitivity–(1-specificity)], was performed to explore whether the sum of positive responses to the whole tool could be used to distinguish: (1) patients from controls; and (2) patients with significant nocturia distress from patients with mild nocturia distress (Question 12 of NQoL).

Assuming a type I error (α) of 0.05 and type II error (1-β) of 0.8, we calculated that:

1. a Spearman’s correlation coefficient (ρ) of 0.4 (with ρ=0.0 for the null hypothesis) required a sample size of 46 participants19;
2. κ=0.4 for each item (with κ=0 for the null hypothesis) for the test-retest reliability of the TANGO (CV) required a minimum sample of 47 respondents.17

Assuming an attrition rate of 20%, approximately 60 participants (patients and controls) were needed.

Continuous data were reported as mean and standard deviation or median and range. Categorical data were described using frequencies and percentages. For comparisons of continuous data, Student’s t test or the Mann-Whitney U test was used, depending on the data distribution; for comparisons of categorical data, the Pearson Chi squared test or Fisher’s exact test was used. The Spearman’s correlation coefficient was used to assess associations between parametric or ordinal data and continuous data with a skewed distribution; the Pearson correlation coefficient was used to assess associations between normally distributed continuous data. SPSS Statistics (Windows version 26.0; IBM Corp, Armonk [NY], United States) was used for data analysis. P values <0.05 were considered statistically significant.

Comparability scores for each item in the TANGO (CV) ranged from 1.38 (0.52) to 2.25 (1.28), with an overall mean score of 1.70 (0.88). Similarity scores for each item ranged from 1.00 (0.52) to 2.13 (1.36), with an overall mean score of 1.63 (0.88). The TANGO (CV) is shown in the online supplementary Table.

This study included 65 participants, which include 51 (78.5%) patients (mean age: 67 years; 35 men, 16 women) with mean self-reported nocturia episodes of 3.39 per night (standard deviation=0.98; range, 2-5) and 14 (21.5%) controls (mean age: 67 years; 11 men, three women) with mean self-reported nocturia episodes of 0.79 per night (standard deviation=0.43, range, 0-1). The demographic and baseline clinical characteristics are shown in Table 1; the bladder/sleep diary–based parameter data are shown in Table 2. The control group had fewer positive responses (median=2.33) to items in the TANGO (CV), less nocturia distress, higher functional bladder capacity during daytime and night-time, and a lower nocturnal urine excretion rate; however, control participants reported similar prevalences of medical conditions that could cause nocturia, compared with patients who experienced ≥2 nocturia episodes/night.

All 65 participants reported that the questions in the tool were clearly presented, and they answered 99.6% of the items in the tool (total items=22 × 65=1430). Two (3%) participants required assistance with comprehension to complete the TANGO (CV). Missing responses were noted for items related to the use of antihypertensives (n=1), the diagnosis of diabetes mellitus/impaired glucose level (n=1), and unstable glucose level (n=1); three men were unable to respond to the question concerning prostate enlargement [Table 3]. In total, 41 (63%) participants reported at least one positive response (total responses=72) in the cardiovascular/metabolic domain, 48 (74%) participants reported at least one positive response (total responses=154) in the sleep-related domain, 54 (83%) participants reported at least one positive response (total responses=119) in the LUTS domain, and 21 (32%) participants reported at least one positive response (total responses=32) in the general well-being domain. The item with most positive responses was nocturia within 3 hours after going to bed (80% of participants) and the item with the fewest positive responses was the use of diuretics (0 responses) [Table 3]. Among the four thematic areas, 90% of participants had positive responses to ≥1 domain. Only three (6%) of the 51 patients with ≥2 nocturia episodes/night exhibited nocturia-related problems that were limited to a single domain.

The KR-20 coefficients of the four domains of the TANGO (CV) were 0.354-0.615 (best in sleep-related and general well-being domains; worst in cardiovascular/metabolic domain), suggestive of fair to moderate subscale internal consistency. For the whole tool, the KR-20 coefficient was 0.711 (ie, >0.700), indicating satisfactory overall internal consistency. Kappa values were between 0.817 and 0.871 for items in each of the four domains and 0.866 for the whole tool, whereas ICCs were between 0.878 and 1.000 for the subtotal positive responses in each of the four domains and 0.972 for the whole tool; these findings indicated near-perfect test-retest reliability.

Table 4 shows the construct (convergent) validity of the TANGO (CV). The sleep-related domain was positively correlated with sleep latency [ρ=0.471 (P<0.001)], whereas it was negatively correlated with sleep quality [ρ=-0.407 (P=0.002)] and vitality after sleep [ρ=-0.467 (P<0.001)], as reported in the bladder/sleep diary. The LUTS domain was positively correlated with the number of nocturia episodes, rate of nocturnal urine production, and volume of nocturnal urine production [ρ=0.513 (P<0.001), ρ=0.333 (P=0.016), and ρ=0.309 (P=0.026), respectively]. However, the LUTS domain was not correlated with sleep/vitality parameters. In contrast, the general well-being domain was significantly positively correlated with the rate and volume of nocturnal urine production [ρ=0.319 (P=0.018) and ρ=0.312 (P=0.021), respectively]; it was significantly negatively correlated with vitality after sleep [ρ=-0.403 (P=0.002)]. The cardiovascular/metabolic domain did not display significant correlations with the bladder/sleep diary parameters. Nonetheless, the whole tool was significantly positively correlated with the number of nocturia episodes [ρ=0.378 (P=0.006)], the rate and volume of nocturnal urine production [ρ=0.394 (P=0.004) and ρ=0.380 (P=0.006), respectively], and sleep latency very closely [ρ=0.275 (P=0.051)]; it was significantly negatively correlated with sleep quality and vitality after sleep [ρ=-0.392 (P=0.004) and ρ=-0.483 (P<0.001), respectively].

Criterion validity was confirmed for each domain and the whole tool (ρ=0.287-0.687). Regarding criterion validity, the cardiovascular/metabolic domain was only significantly correlated with the STOP-Bang questionnaire. The sleep-related domain was not correlated with questionnaires specifically designed to assess obstructive sleep apnoea. However, this domain was strongly correlated with the IPSS, IPSS QoL, and the sleep/energy, bother/concern, and total domains of NQoL (Table 5). The LUTS domain was significantly correlated with the STOP-Bang questionnaire, IPSS, OABSS questionnaire, and NQoL; the strongest correlations involved IPSS total [ρ=0.651 (P<0.001)], OABSS [ρ=0.642 (P<0.001)], and NQoL bother/concern [ρ=0.551 (P<0.001)]. In contrast to the LUTS domain, the general well-being domain was significantly correlated with the ESS; it was also correlated with the IPSS, OABSS questionnaire, ICIQ-N-4(b) and NQoL, but these correlations were weaker than the correlations of the LUTS domain (Table 5).

Receiver operating characteristic analysis (Fig) showed that a cut-off of four positive responses on the TANGO (CV) could distinguish patients from controls (Youden’s J statistic=0.453; area under the curve=0.818, 95% confidence interval [CI]=0.683-0.953; odds ratio=7.81, 95% CI=2.02-30.30; sensitivity: 83%, specificity: 62%), whereas a cut-off of five positive responses could distinguish patients with significant nocturia distress from patients with mild nocturia distress (Youden’s J statistic=0.398; area under the curve=0.729, 95% CI=0.581-0.878; odds ratio=4.07, 95% CI=1.17-14.15; sensitivity: 70%, specificity: 63%).

The International Continence Society (ICS) defines nocturia as the need to wake at least once during the night to void. Each instance of voiding is preceded and followed by sleep.20 A recent Delphi panel convened by the ICS5 recommended using disease-specific questionnaires in the diagnostic pathway for nocturia. In English, there are a few psychometrically validated disease-specific measurement tools for nocturia: the NQoL, developed and validated by Abraham et al12; the ICIQ-N, a form of the NQoL modified from the ICIQ (https://iciq.net/iciq-nqol); and the Nocturia, Nocturnal Enuresis and Sleep-Interruption Questionnaire (NNES-Q) developed by Bing et al.21 The ICIQ-N11 is a combined questionnaire that incorporates a bladder diary–Nocturia Impact Diary.22 However, all of these tools mainly focus on the impact of nocturia on distress and quality of life in affected patients; none of them explore the aetiologies of nocturia.

The TANGO has emerged as a questionnaire that can capture information concerning the multifaceted nature of nocturia and identify nocturia-related co-morbidities.7 23 This tool is expected to be useful across various medical specialties to facilitate, improve, and accelerate the process of nocturia management. Thus far, the TANGO has been translated into Dutch,24 Arabic,25 and Turkish.26 However, none of these translated versions have been subjected to validity assessment using a bladder/sleep diary. To our knowledge, the present study is the first to perform such an assessment.

The ages of our study participants were similar to that of individuals in whom nocturia is commonly observed (>60 years). We found that the TANGO (CV) could be easily comprehended by patients visiting urology clinics, as indicated by the small percentage of missing responses (0.4%) and minimal need for assistance from medical staff (97%); these results suggested good content validity. The low rate of missing responses might be related to the dichotomous-choice nature of responses to items, which facilitated answers by participants.

In all, 94% of our participants with ≥2 nocturia episodes/night were affected by multiple domains of aetiological factors/nocturia-related co-morbidities; approximately 8% of patients reported experiencing falls, which is a higher percentage than in a previous study that used a nocturia-specific questionnaire (<3%).27 The distribution of aetiologies/co-morbidities of nocturia in our study was similar to the distribution reported by a Turkish group26: the LUTS domain was most commonly observed, followed by the sleep-related domain, and then the cardiovascular/metabolic domain. However, the rate of poor general well-being was lower in the present study than in the Turkish study. The simple TANGO (CV) can easily capture information concerning the multifactorial nature of nocturia that could be not elucidated by other nocturia-specific questionnaires.11 12 21 22 Thus, it will facilitate the provision of more individualised treatment for nocturia.

The KR-20 coefficient for the whole tool was 0.711 (>0.700), confirming the internal consistency of the whole TANGO (CV) tool. The highest domain-specific positive response correlation coefficient was observed in the sleep-related domain, implying that nocturia is closely related to impaired sleep quality and disrupted sleep architecture.

The high ICC value (>0.8) for each domain of nocturia-related problems confirmed the excellent test-retest reliability of the tool, in combination with the convergent validity identified in the sleep-related, LUTS, and general well-being domains of the TANGO (CV). With the exception of the cardiovascular/metabolic domain, criterion validity was also established for other domains and the whole TANGO (CV) tool; the criterion validity was the greatest in the LUTS domain, followed by the sleep-related domain and then the general well-being domain. Importantly, the original version of the TANGO7 does not provide a symptom score, although such a score is strongly recommended in European Association of Urology guidelines as a means of quantifying symptoms and distinguishing patients with mild problems from patients with severe problems.28 In this regard, a scoring system involving the various domains of the TANGO has recently been proposed to distinguish the relative contributions of nocturia aetiologies to treatment outcomes.8 In the present study, we showed that by using cut-offs of four and five positive responses, respectively, the sum of the positive responses could distinguish individuals with more nocturia episodes (≥2/night) from individuals with fewer nocturia episodes (≤1/night), and patients with significant nocturia distress (Question 12 of NQoL) from patients with mild nocturia distress (Fig). These findings confirmed the discriminatory validity of the TANGO (CV).

The cardiovascular/metabolic domain demonstrated suboptimal performance in terms of internal consistency, convergent, criterion, and discriminant validity. These findings might be related to selection bias in that patients with higher cardiovascular risk were not recruited [ie, there was a low positive response rate (72 of 455 potential responses, 16%)].

The TANGO (CV) can be used to investigate common aetiologies and nocturia-related outcomes across multiple medical specialties, providing guidance for subsequent treatment. For example, positive responses to Questions 1, 2, and 3 in the cardiovascular/metabolic domain and Question 13 in the sleep-related domain may indicate that desmopressin is less appropriate or even contraindicated for the treatment of nocturia, in accordance with the recent consensus report by the ICS.5 The questionnaire can also be used as a screening tool for epidemiological studies and routine clinical work-up for nocturia. It is a simple, rapid, easily understood, and clinically meaningful tool that can help clinicians to thoroughly evaluate nocturia aetiology and related problems earlier in the clinical pathway of nocturia treatment. Moreover, it may be useful in categorising or predicting the prognosis of nocturia in adults.

The limitations of the current study included the fact that about 70% of the participants were men, which may limit its utility in assessment of female patients with nocturia. Additionally, the sample size was insufficient to clarify correlations among domain variables, number of positive responses, and subtotal and total symptom scores across the various questionnaires used for validation. The inclusion of patients with more pronounced illnesses within the studied domains should be considered to clearly identify relationships among nocturia, aetiologies, lower urinary tract function, and co-morbidities, as measured by bladder/sleep diaries and validated questionnaires.

The TANGO (CV) is a multi-dimensional, self-administered, formally translated, psychometrically validated Chinese version of the TANGO. It can be used to screen for aetiologies and measure the impacts of nocturia-related problems on affected individuals, including their quality of life. The sum of positive responses to the whole tool was significantly correlated with the degree of nocturia-related distress.

Concept or design: SKK Yuen, W Bower, CF Ng.
Acquisition of data: SKK Yuen, CSY Li, HSW Kwok.
Analysis or interpretation of data: SKK Yuen, PKF Chiu, JYC Teoh.
Drafting of the manuscript: SKK Yuen, CF Ng.
Critical revision of the manuscript for important intellectual content: SKK Yuen, CF Ng, SSM Hou.

All authors had full access to the data, contributed to the study, approved the final version for publication, and take responsibility for its accuracy and integrity.

As editors of the journal, CF Ng and JYC Teoh were not involved in the peer review process. Other authors have disclosed no conflicts of interest.

We thank all staff from Lithotripsy and Uro-investigation Centre of Prince of Wales Hospital and research staff from Department of Urology of The Chinese University of Hong Kong for facilitating the data collection.

This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.

The study protocol was approved by the Joint Chinese University of Hong Kong—New Territories East Cluster Clinical Research Ethics Committee (Ref No.: 2019.400), in accordance with the Declaration of Helsinki and the Good Clinical Practice guidelines. Informed consent to take part in the research was obtained from all participants.

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