Cross-Cultural Adaptation and Psychometric Evaluation of the Brazilian Portuguese Version of the Nocturia Quality-of-Life Questionnaire.

INTRODUCTION AND HYPOTHESIS: The objective was to cross-culturally adapt and check for the reliability, internal consistency, and validity of the Nocturia Quality of Life Questionnaire (N-QoL) in Brazilian Portuguese (N-QoL-Br). METHODS: The questionnaire was translated according to international guidelines, included forward-translation, back-translation, and consensus among an expert committee. Participants with nocturia completed the Pittsburgh Sleep Quality Index, International Consultation on Incontinence Questionnaire Overactive Bladder, and the General Quality of Life Assessment Questionnaire SF-36 (Medical Outcomes Study 36-Item Short-Form Health Survey), in addition to the N-QoL-Br. The Brazilian version was applied in men and women with nocturia twice within a range of 4 weeks. Psychometric properties such as content validity, construct validity, internal consistency, and test-retest reliability were tested. RESULTS: Content validity was considered adequate. Eighty-four men and women participated in the study. Good internal consistency in the domains and final score of the N-QoL-Br was observed, with Cronbach α greater than 0.9. The test-retest reliability was also high, with an intraclass correlation coefficient greater than 0.9 for the domain sleep/energy, bother/concern, and total score (0.98, 0.98, and 0.97 respectively). CONCLUSIONS: The Portuguese version of the N-QoL-Br presents good internal consistency and reproducibility and it can be considered adequate and valid for evaluating the impact of nocturia on the quality of life of men and women in the Brazilian population.

Psychometric properties and moderated mediation analysis of the ICIQ-NQOL in Chinese primary care patients with nocturia.

BACKGROUND: Many individuals consider nocturia a significant nuisance, leading to a reduced health-related quality of life (HRQOL). However, there has been a lack of psychometrically sound patient-reported outcome measures to assess the impact of nocturia on patients in Chinese contexts. This study aimed to translate, culturally adapt, and validate the International Consultation on Incontinence Questionnaire Nocturia Quality of Life Module (ICIQ-NQOL) for use among primary care patients in Hong Kong, China. Additionally, it sought to investigate the mechanisms that link nocturia and sleep quality with HRQOL by employing moderated mediation analysis. METHODS: The traditional Chinese version of the ICIQ-NQOL was developed through iterative translations, cognitive debriefing interviews, and panel reviews. The psychometric evaluation included assessments of factor structure, convergent validity, concurrent validity, known-group validity, internal consistency, test-retest reliability and responsiveness. Study instruments included the ICIQ-NQOL, International Prostate Symptom Score (IPSS), Pittsburgh Sleep Quality Index (PSQI), and a modified Incontinence Impact Questionnaire-Short Form (IIQ-7). RESULTS: A total of 419 primary care patients were recruited from general outpatient clinics, among whom 228 experiencing an average of two or more nocturia episodes per night over the past four weeks. Confirmatory factor analysis supported the two-factor structure of the ICIQ-NQOL. Concurrent validity was confirmed by moderate correlations between the IIQ-7 total score and the total score as well as two domain scores of the ICIQ-NQOL (r ranging from 0.43 to 0.49, all p < 0.001). The ICIQ-NQOL also had moderate correlations with the IPSS total symptom score (r ranging from 0.40 to 0.48, all p < 0.001). Convergent validity was supported by moderate correlations between the global PSQI score and the total score as well as two domain scores of the ICIQ-NQOL (r ranging from 0.42 to 0.52, all p < 0.001). Known-group comparisons showed that the ICIQ-NQOL could differentiate between patients with and without nocturia in terms of sleep/energy domain score (p < 0.001), bother/concern domain score (p < 0.001), and total score (p < 0.001), each demonstrating a moderate Cohen's d effect size. Item-total correlations corrected for overlap exceeded 0.4, and Cronbach's alpha coefficients were greater than 0.7. Test-retest reliability was confirmed with intraclass correlation coefficients exceeding 0.7 among patients reporting no change in their nocturia symptoms at a 2-week follow-up. Regarding responsiveness, the Cohen's d effect sizes for differences in domain and total scores between the baseline and 2-week follow-up assessments were greater than 0.3 among patients showing improvement in nocturia. Our moderated mediation analysis indicated that sleep quality significantly moderated the impact of nocturia on HRQOL, with a notably stronger indirect effect among females compared to males. CONCLUSIONS: The ICIQ-NQOL is a reliable and valid instrument for assessing the HRQOL in primary care patients suffering from nocturia. The findings advocate for gender-specific approaches in the management and treatment of nocturia to optimize HRQOL.

Factors related to nocturia-specific quality of life in renal transplantation patients.

OBJECTIVES: Patients following renal transplantation (RTX) may experience nocturia exacerbation due to polyuria and reduced bladder capacity, thereby impacting the specific quality of life (QOL) associated with nocturia. The present study aims to investigate factors associated with the deterioration of nocturia-specific QOL in RTX patients. METHODS: The study cohort comprised 59 consecutive patients who had undergone successful RTX. Nocturia-related QOL questionnaires (N-QOL) were employed to evaluate the specific QOL related to nocturia. The Bother/Concern and Sleep/Energy domains of the N-QOL were also assessed. The primary outcome measure was to explore factors related to the aggravation of nocturia-specific QOL in patients post-RTX. RESULTS: The mean nocturia frequency post-RTX was 1.3 ± 1.0. Univariate and multivariate analyses revealed a significant reduction in the Bother/Concern domain score associated with increased nocturia (p = .042). Aging significantly decreased the total N-QOL score and the Sleep/Energy domain score (p = .001 and .0002, respectively). Prolonged duration after RTX significantly reduced the scores of both the Sleep/Energy domain and the Bother/Concern domain (p = .018 and .037, respectively). However, the duration of dialysis prior to RTX was not significantly associated with the total score or subdomains of N-QOL. CONCLUSIONS: Nocturia-specific QOL affected not only the nocturia itself, but also aging and the prolonged duration after RTX. Thus, comprehensive approaches to the RTX patients were needed to improve the Nocturia-specific QOL in RTX patients.

Overactive bladder: not just a normal part of getting older.

Overactive bladder (OAB) is a common yet under-reported condition affecting both men and women. Prevalence rises with age, but OAB can affect people of any age. It is associated with increased physical and mental health problems and may lead to social isolation and escalating care needs. It is a clinical diagnosis with symptoms of urgency, with or without urge incontinence and usually with urinary frequency and nocturia. Management includes conservative, medical and surgical treatments, which can significantly improve quality of life. This review aims to raise awareness of this under-reported condition and to empower health professionals to open discussions on bladder health with all those in their care.

Treatment for overactive bladder: A meta-analysis of transcutaneous tibial nerve stimulation versus percutaneous tibial nerve stimulation.

BACKGROUND: We aim to compare the safety and effectiveness of transcutaneous tibial nerve stimulation (TTNS) versus percutaneous tibial nerve stimulation (PTNS) in treating overactive bladder. METHODS: A systematical search on PubMed, Embase, clinicalTrial.gov, and Cochrane Library Central Register of Controlled Trials from January 1, 1999 to November 1, 2020 was performed. The primary outcomes were the changes in a 3-day voiding diary. Quality of life scores were also evaluated. Review Manager 5.3 (Cochrane Collaboration, Oxford, UK) was applied to conduct all statistical analyses. RESULTS: A total of 4 trials (2 randomized controlled trials, 1 retrospective study, and 1 before-after study) with 142 patients were eventually enrolled. Compared with PTNS, TTNS had a similar performance in the voiding frequency in 24 hours (mean difference [MD] = -0.65, 95% confidence interval [CI]: -1.35 to 0.05, P = .07), the number of urgency episodes in 24 hours (MD = 0.13, 95% CI: -0.36 to 0.62, P = .60), the number of incontinence episodes in 24 hours (MD = 0.01, 95% CI: -0.13 to 0.14, P = .93), as well as in the nocturia frequency (MD = -0.14, 95% CI: -0.52 to 0.24, P = .47). Moreover, comparable results were observed regarding HRQL scores (P = .23) and incontinence quality of life scores (P = .10) in both groups. The total complication rate in the current study was 2.1% (3/142). No adverse events were identified in the TTNS group. CONCLUSION: Current data supported that TTNS is as effective as PTNS for the treatment of overactive bladder, moreover, with no reported adverse events. However, the evidence is low-grade and well-designed prospective studies with a large sample size are warranted to verify our findings.

Achieving clinically meaningful quality of life benefits in nocturia takes time: Results from a long-term, multicenter phase 3 study of desmopressin in Japanese patients.

OBJECTIVES: To investigate the long-term efficacy, quality of life (QoL), and safety of desmopressin orally disintegrating tablets (ODTs) in Japanese patients with nocturia. METHODS: A long-term, multicenter phase 3 study was conducted that enrolled Japanese male and female patients with nocturia (NCT03051009). Male patients received desmopressin 25- or 50-µg ODTs, and female patients received desmopressin 25-µg ODTs for up to 1 year. The primary endpoint was safety. Secondary endpoints included change from baseline in number of nocturnal voids, time to first awakening to void, and QoL assessments (nocturia-specific zQoL [N-QoL], Insomnia Severity Index [ISI], and Hsu bother score). RESULTS: Overall, 503 patients were enrolled. Reductions from baseline in mean number of nocturnal voids were observed in all treatment groups from week 1 (-0.62 to -1.00), with improvements continuing through week 52 (-1.39 to -1.71). Changes from baseline above or approximating a clinically meaningful improvement were seen by week 52 in the disease-specific N-QoL total score (improved by 11.5-22.6), ISI (improved by -3.9 to -7.1), and Hsu bother scores (improved by -1.5 to -2.0). Adverse events (AEs) were reported in 54.9% of desmopressin-treated patients. Most AEs were mild or moderate in severity. CONCLUSIONS: Desmopressin ODTs (25 and 50 µg) demonstrated long-term efficacy, improved QoL, and were well tolerated in Japanese male and female patients with nocturia treated for up to 1 year. Clinically meaningful improvements in patients' QoL, assessed by N-QoL, sleep quality, and bother, occur later than objective symptom improvements, such as voids.

Enduring impact of childhood adversity on lower urinary tract symptoms in adult women.

AIMS: To determine whether childhood adversity is associated with self-reported lower urinary tract symptoms (LUTS) among older adult women. METHODS: A convenience sample of women (≥55 years old) who presented to an academic urology practice or who had participated in a previous bladder health prevention study completed questionnaires including the LUTS Tool (on frequency and bother of LUTS), the Adverse Childhood Experiences (ACEs) Questionnaire, the Spielberger State-Trait Anxiety Inventory, and the Center for Epidemiologic Studies Depression Scale. RESULTS: The average age (SD) of participants (N = 151) was 64.7 (6.9) years. The total number of ACEs predicted the total number of LUTS, ß = .39 (95% confidence interval [CI] = 0.14, 0.64), P = .003, as well as LUTS frequency, ß = .09 (95% CI = 0.04, 0.13), P < .001. ACEs predicted bother for nocturia, ß = 0.12 (95% CI = 0.03, 0.22), P = .008. Negative affect symptoms did not mediate the relationship between the total number of ACEs and the total number of LUTS. Rather, ACEs predicted LUTS and negative affect symptoms through (at least partially) independent pathways. Analyses controlled for tobacco use, number of vaginal deliveries, hypertension, overactive bladder medication use, body mass index, income, and race because these variables were significantly associated with the total number of ACEs or total number of LUTS. CONCLUSIONS: Childhood adversity has an enduring impact on risk for LUTS in adulthood even when controlling for potential confounds and this relationship cannot be explained by negative affect symptoms.

Nocturia in Women With Type 2 Diabetes Mellitus: A Cross-sectional, Correlation Study.

PURPOSE: The first aim of this study was to compare nighttime voiding frequency (nocturia), serum hemoglobin A1c level, peripheral neuropathy score, and global sleep quality score in younger (>40 to <65 years) versus older (≥65 years) women with type 2 diabetes mellitus (DM). Additional aims were to identify factors associated with clinically relevant nocturia (≥2 episodes/night) and to analyze relationships between nocturia frequency, glycemic control, peripheral neuropathy, and sleep quality in these women. DESIGN: Cross-sectional study. SETTING AND SUBJECTS: Participants were 118 women older than 40 years and with type 2 DM. Their mean age was 65.25 (SD = 9.66) years; the mean duration since diagnosis of type 2 DM was 10.96 (SD = 7.66) years. The study setting was 2 metabolism and endocrinology outpatient departments located in Taipei City and Taoyuan, Taiwan. METHODS: Data were collected using a questionnaire that queried sociodemographic information, lower urinary tract symptoms, and sleep quality. We also assessed peripheral neuropathy and lower extremity edema and obtained pertinent information from participants' medical records. Independent t tests, multivariate logistic regression analyses, Spearman's rank correlation coefficients, and one-way analysis of variance were used to address the 3 study aims. RESULTS: Analyses found that older women (aged ≥65 years) had a significantly higher nighttime voiding frequency, a higher peripheral neuropathy score, and a higher sleep quality score than younger (>40 to <65 years) women. Multivariate logistic regression analyses identified 4 factors associated with clinically relevant nocturia advanced age, elevated hemoglobin A1c level, suspected peripheral neuropathy, and lower extremity edema. Significant correlation coefficients were found between nighttime voiding frequency and serum hemoglobin A1c levels, peripheral neuropathy scores, and sleep quality scores. Analyses also found that women with a greater nocturia frequency had higher hemoglobin A1c levels, peripheral neuropathy scores, and sleep quality scores. CONCLUSIONS: Healthcare professionals should screen for nocturia in women with type 2 DM and provide appropriate management for those experiencing nocturia.

Longitudinal Analysis of Bidirectional Relationships between Nocturia and Depressive Symptoms: The Nagahama Study.

PURPOSE: Although the association between nocturia and depressive symptoms has been demonstrated, the causal direction remains unclear. We investigated the directional association between nocturia and depressive symptoms using longitudinal data from the general population. MATERIALS AND METHODS: This longitudinal analysis was conducted as part of the Nagahama Cohort Project, a population based cohort study, with baseline and 5-year followup investigations. Nocturnal voiding frequency and mental health were measured with self-report questionnaires, the International Prostate Symptom Score and the 5-item Mental Health Inventory. Logistic regression analyses and a cross-lagged panel analysis were performed to analyze the bidirectional association between nocturia and depressive symptoms. RESULTS: With 9,764 participants at baseline, data from 8,285 were used in this analysis. Median age at baseline was 57.3 years and the proportion of men was 32.0%. New onset depressive symptoms and nocturia were observed among 369 and 793 participants, respectively. In adjusted logistic regression analyses we observed a clear dose-relationship between baseline nocturnal voiding frequency and new onset depressive symptoms (p for trend <0.001) and a weak association between baseline 5-item Mental Health Inventory and new onset nocturia (p for trend=0.0087). In a cross-lagged panel analysis the path coefficient from nocturnal voiding frequency to 5-item Mental Health Inventory (ß=-0.06, p <0.001) was stronger than that from 5-item Mental Health Inventory to nocturnal voiding frequency (ß=-0.02, p=0.047). CONCLUSIONS: This longitudinal study demonstrated a bidirectional association between nocturia and depressive symptoms. The cross-lagged path coefficient suggested that nocturia could more likely be a cause than a result of depressive symptoms.

The mediating role of sleep quality in the association between nocturia and health-related quality of life.

BACKGROUND: Even though the negative impacts of nocturia on sleep quality and health-related quality of life (HRQOL) have been documented in previous research, their interrelationship has been poorly studied. This study aimed to explore whether nocturia would affect sleep quality, which in turn affects HRQOL. METHODS: Participants aged 40 and above were randomly recruited from a Hong Kong public primary care clinic. Participants were asked to report the average number of nocturia (waking up at night to void) pisodes per night over a 1-month period. The Pittsburgh Sleep Quality Index (PSQI) and the 12-Item Short Form Health Survey version 2 (SF-12 v2) were administered. The mediation analysis was tested using multistage regression approach and bootstrap method. RESULTS: Of the 500 subjects who completed the survey, 31.2% reported symptomatic nocturia (having ≥2 nocturia episodes per night), and 60.4% experienced poor sleep quality (a PSQI global score > 5). Respondents with symptomatic nocturia had a poorer HRQOL in the domains of physical functioning (PF), role physical (RP) and social functioning (SF), general health (GH), vitality (VT) and physical component summary (PCS) of the SF-12 v2 than those without. Compared with the respondents without poor sleep quality, those with poor sleep quality had poorer HRQOL across all domains and summaries of the SF-12 v2. Mediation analysis found that sleep quality fully mediated the association between nocturia and the PF, RP and SF domains of the SF-12 v2, respectively, and partially mediated the association between nocturia and the GH, VT and PCS domains of the SF-12 v2, respectively. CONCLUSIONS: We found that sleep quality mediated the association between nocturia and HRQOL. To enhance the HRQOL of patients with nocturia, clinicians should not only focus on nocturia symptoms, but also on their sleep quality.

Nocturnal voiding frequency does not describe nocturia-related bother.

AIM: Nocturia frequency has been used as a measure of treatment efficacy for nocturia even though fluctuation of the symptom over time has been well described in the literature. Additionally, given the multifactorial causal pathway and clinically relevant comorbidities, frequency alone may be an insufficient marker of treatment direction. The aim of this study was to investigate factors associated with nocturia-related bother to identify additional variables that may capture the impact of nocturia, direct clinical care and have potential to quantify treatment outcome. METHODS: Prospective data from tertiary hospital Urology and Continence cohorts were matched for identical variables to generate a sample of 204 datasets. Descriptive statistics were obtained to describe the two cohorts. Characteristics of patients were evaluated across levels of nocturia frequency and nocturia-related bother using nonparametric methods; statistically significant differences between groups in each cohort were established. RESULTS: Nocturia frequency alone does not comprehensively reflect attributable bother. Five sleep variables (poor quality sleep, short time to first awakening to void, less than 7 hours of total sleep, primary sleep latency, and daytime sleepiness) and daily urinary urgency were significantly associated with high nocturia-related bother. Attributable bother, despite high-frequency nocturia, was minimized by male gender, lack of daily urinary urgency and good sleep quality. Poor health status, urinary urgency and sleep latency were associated with nocturia frequency. CONCLUSIONS: Items of importance to individuals with nocturia have been identified from patient data. These variables have the potential to sit alongside change in nocturia frequency as potential markers of treatment response.

Development of the Nocturia Sleep Quality Scale: a patient-reported outcome measure of sleep impact related to nocturia.

BACKGROUND/OBJECTIVE: Nocturia's impact on sleep causes significant burden for patients. This study aimed to develop a novel patient-reported outcome (PRO) measure, the Nocturia Sleep Quality Scale (NSQS), for the assessment of the impact of nocturia (defined as ≥2 nocturnal voids/night) on sleep. METHODS: Sleep-related concepts were identified through a targeted literature review, after which in-depth concept elicitation interviews with patients with a clinical diagnosis of nocturia were conducted. Draft items were generated to address concepts identified as important, meaningful, and relevant. Items were further refined through three iterative sets of cognitive debriefing interviews to optimize instructions, question wording, and response options. Two sleep research experts also provided input. RESULTS: The literature review and data from 18 concept elicitation interviews provided the basis for a comprehensive set of concepts. Constant comparative analysis was used to identify themes and support item development. The draft questionnaire consisted of 14 items with item-specific response scales. Wording and scaling of the items was optimized based on feedback from the 22 cognitive debriefing interviews and expert input. The results confirmed the completeness and relevance of the NSQS, providing support for the content validity and ability of items to reflect patient perception of nocturia-related sleep impacts. CONCLUSIONS: The 6-item NSQS assesses the impact of nocturia on sleep by evaluating nighttime awakenings, sleep quantity, and sleep quality. The NSQS is self-administered and is intended to assess change in nocturia's impact on sleep after treatment in a standardized manner. Psychometric evaluation is under way to describe key measurement properties.

Factors involved in sleep efficiency: a population-based study of community-dwelling elderly persons.

STUDY OBJECTIVES: Research indicates that sleep efficiency below 80% substantially increases mortality risk in elderly persons. The aim of this study was to identify factors that would best predict poor sleep efficiency in the elderly, and to determine whether associations between these factors and sleep efficiency were similar for men and women and for younger and older elderly persons. METHODS: A total of 2468 individuals aged 65-96 years (40.7% men) participated. They were recruited via random generation of telephone numbers according to a geographic sampling strategy. The participants agreed to have health professionals visit their home and to answer structured interview questions. Sleep efficiency was calculated based on interview responses. Descriptive statistics and logistic regressions were conducted. RESULTS: The factors most strongly associated with sleep efficiency below 80% were pain, nocturia, sleep medication use, and awakening from bad dreams. Some factors varied by sex: women aged 75 years and older or who had an anxiety disorder were more likely to have sleep efficiency below 80%, whereas being single or having painful illness raised the likelihood for men only. Except for sex, all the factors that showed associations with sleep efficiency affected younger and older elderly persons similarly. CONCLUSIONS: Poor sleep efficiency is prevalent among elderly persons. The results shed new light on factors associated with poor sleep efficiency, highlighting the presence of sex differences and that certain factors make no significant contribution, such as typically proscribed sleep hygiene behaviors, mood disorders, and illness in general.

Sleep Disturbance Has a Higher Impact on General and Mental Quality of Life Reduction than Nocturia: Results from the Community Health Survey in Japan.

BACKGROUND: Nocturia has been reported to be associated with sleep disturbance. However, whether nocturia or sleep disturbance has a more negative influence on the quality of life (QOL) of individuals remains unclear. OBJECTIVE: To compare the impact of nocturia and sleep disturbance on QOL. DESIGN, SETTING, AND PARTICIPANTS: This was a cross-sectional study including 3992 adults who participated in the Iwaki Health Promotion Project between 2011 and 2015 in Hirosaki, Japan. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: Sleep disturbance and nocturia were assessed in all participants using the Pittsburgh Sleep Quality Index (PSQI), international prostate symptom score for men, and overactive bladder symptom score for women. Sleep disturbance was defined as a PSQI score of ≥6. QOL was measured using the Short Form-36 questionnaire. Impacts of nocturia and sleep disturbance on QOL reduction (>30%) were investigated using logistic regression analyses. RESULTS AND LIMITATION: Of the 3992 participants, sleep disturbance was observed in 632 (16%). The frequency of nocturia was significantly associated with PSQI scores. Of QOL domains, both sleep disturbance and nocturia were significantly associated with decreases in the physical component summary score (physical QOL). However, nocturia was not associated with general health (general QOL) and mental component summary (mental QOL) scores. Multivariate logistic regression analysis showed that nocturia was not associated with a >30% reduction in general and mental QOL, whereas sleep disturbance was significantly associated with general, physical, and mental QOL reduction. As this was a cross-sectional study, the causality of nocturia and sleep disturbance could not be assessed. CONCLUSIONS: Nocturia and sleep disturbance affect QOL domains differently. Sleep disturbance has a higher impact on general and mental QOL reduction than nocturia. PATIENT SUMMARY: We compared the impact of nocturia and sleep disturbance on quality of life (QOL). Nocturia was not associated with general and mental QOL reduction, whereas sleep disturbance was associated with general, physical, and mental QOL reduction.

Nocturia has no impact on depression severity in patients suffering from depression but correlates with sleep quality. / Nykturia nie wplywa na nasilenie depresji u cierpiacych na nia pacjentów, ale koreluje z zaburzeniami snu.

OBJECTIVES: In general population, the relationship between nocturia, depressive symptoms and sleep disturbance has been widely investigated. However, there is a paucity of data analyzing the significance of nocturia for depression severity and potential influence of nocturia on sleeping problems in depressed patients. To address this vacuum, we analyzed the impact of nocturia on depression severity and sleep quality in patients suffering from depression. METHODS: We conducted a cross-sectional study of depressed patients treated in outpatient and inpatient Department of Adult Psychiatry, Jagiellonian University, Krakow. All patients met the DSM-5 and ICD-10 criteria for depression. Nocturia was assessed with the International Prostate Symptom Score (IPSS), severity of depression with the 17-item Hamilton Rating Scale for Depression (HRDS), and sleep quality with the Holland Sleep Disorders Questionnaire (HSDQ). Statistical analysis was carried out using an ANOVA test (post-hoc Tukey test). RESULTS: Totally, 98 patients were included in our analysis. Nocturia was reported by 68 individuals. Majority of our patients (35) suffered from mild depression. The mean HSDQ score was 78.8 (range 32-146). Our analysis rejected the impact of nocturia on depression severity (p = 0.625) but revealed statistically significant correlation between nocturia and sleep quality (p = 0.037). A post-hoc test investigating the relationship between severity of nocturia and sleeping problems has demonstrated that higher number of night-time episodes of urination (at least 3 episodes) leads to significantly higher scores in the HSDQ. CONCLUSIONS: Our analysis showed no impact of nocturia on illness severity in patients suffering from depression. However, we demonstrated correlation between nocturia and sleep quality in depressed individuals. Further studies with a larger number of patients are needed to validate the obtained results.

Comparison of urologic and non-urologic presentation in interstitial cystitis/bladder pain syndrome patients with and without Hunner lesions.

AIMS: To compare severity and characteristics of urologic pain, other urinary symptoms, sexual pain, psychosocial health, and the distribution and intensity of non-urologic pain between men and women with and without Hunner lesions. METHODS: All cystoscopies were performed and documented by the same clinician to ensure uniform recognition of Hunner lesions. Intensity of urologic and sexual pain, nocturia, frequency, urgency, and bladder hypersensitivity features were assessed using validated questionnaires and numeric rating scales. The distribution and intensity of non-urologic pain was assessed using self-reported history, a body map diagram, and numeric rating scales. Somatic symptom burden, depression, and anxiety were compared. RESULTS: Among the 150 participants, 27% (n = 41) had Hunner lesions (36% of men, 25% of women). Participants with Hunner lesions were significantly older (median age 58 vs 41, P < 0.001). They reported less intense urologic pain (5 vs 7, P = 0.024) and more nocturia (ICSI nocturia symptom score: 4 vs 3, P = 0.007). They also were less likely to have a history of irritable bowel syndrome (15% vs 36%, P = 0.013) and anxiety attacks (22% vs 44%, P = 0.013). Close to half of Hunner IC patients had non-urologic pain outside the pelvis. There were no differences in bladder hypersensitivity features (eg, painful bladder filling) between the two groups. CONCLUSIONS: Hunner lesions can be identified in both men and women. There are significant overlaps in terms of their urologic and non-urologic presentation. Further investigation is needed on phenotypic and biological distinction between IC/BPS with and without Hunner lesions.

Nocturia is more bothersome than daytime LUTS: Results from an Observational, Real-life Practice Database including 8659 European and American LUTS patients.

PURPOSE: Lower urinary tract symptoms (LUTS) encompass several diagnoses, including overactive bladder (OAB) and benign prostatic hyperplasia (BPH). Nocturia is a standalone symptom, but also included in OAB and BPH. Current discussion addresses whether the overlap of the diagnoses is too broad, leading to misdiagnosis. This study explored the differences in level, causes and consequences for patients with a diagnosis of daytime LUTS compared with a diagnosis of nocturia, and discussed whether people are being treated for the symptoms that truly bother them the most. PATIENTS AND METHODS: Data were drawn from a survey of physicians and patients in France, Germany, Spain, UK and USA. Physicians filled out patient record forms (PRFs) for patients with LUTS diagnosis. The patients completed the patient self-completion form (PSC). Three PRO questionnaires were included; the OAB-q SF, NI-Diary and WPAI. Patients were grouped based on the diagnoses assigned to them by their physicians in a real-life setting. RESULTS: Eight thousand seven hundred and thirty eight patients had a LUTS diagnosis and 5335 completed a PSC. Patients diagnosed with night-time symptoms were significantly more bothered by their LUTS than only daytime LUTS patients (all questionnaires P < .0001). Patients with nocturia reported being tired "always" or "usually" more often than patients with daytime problems only (P < .0001). Only 13% of patients with nocturia had an initial sleep period of more than 2-3 hours. CONCLUSION: In this population of real-life patients, those with a diagnosis of nocturia reported significantly higher impact on their quality of life than patients with a diagnosis of daytime LUTS only. The underlying causes of bother were related to sleep problems. It is essential that nocturia is understood, treated and monitored as a distinct problem from OAB and BPH, to ensure that patients are treated for their main symptom.

Development of the Impact of Nighttime Urination (INTU) questionnaire to assess the impact of nocturia on health and functioning.

AIMS: This study describes development of the Impact of Nighttime Urination (INTU) questionnaire to assess nocturia impacts on health and functioning. METHODS: Development of the questionnaire followed an iterative patient-directed process as recommended by current guidance for patient-reported outcome (PRO) measures. An initial 15-item questionnaire was devised based on reviewing the published literature, and then modified through four rounds of semi-structured interviews of 28 individuals with nocturia. In each round, open-ended concept elicitation, followed by cognitive debriefing, was used to assess the questionnaire. Items were modified based on participants' responses and incorporated into the next round of interviews. RESULTS: In all rounds, participants reported that their experiences were easy to recall and report on a daily basis and that the burden of completing the questionnaire was low. The final questionnaire has a same-day recall period. It includes six daytime impact items-having limited concentration, a sense of feeling tired, difficulty getting things done, irritability, not feeling rested, and drowsiness-and four items that measure the nighttime impact of nocturia-patient concern, waking up too early, difficulty getting enough sleep, and feeling bothered by having to get up at night to void. Responses follow a 5- or 4-point scale. The final INTU captures the key concepts associated with nocturia as confirmed by cognitive debriefing. CONCLUSIONS: Development of the 10-item INTU, a nocturia-specific PRO measure, was based on direct input and feedback from patients and has demonstrated that it captures the patient-reported impacts of nocturia.

Development of a new patient-reported outcome (PRO) measure on the Impact of Nighttime Urination (INTU) in patients with nocturia-Psychometric validation.

AIMS: To psychometrically evaluate the Impact of Nighttime Urination (INTU) questionnaire, a new patient-reported outcome measure developed to assess the impact of nocturia on health and functioning in a multicenter, behavioral modification (fluid restriction) study. METHODS: Participants aged 50-95 years with at least two voiding episodes/night for ≥6 months completed voiding diaries and the INTU on 3 consecutive days during weeks 1 and 2 (same day recall) and completed the Pittsburgh Sleep Quality Index (PSQI) and Nocturia Quality of Life Questionnaire (N-QOL) at baseline and days 8 and 15. Psychometric evaluations of the INTU were conducted. RESULTS: Rasch analysis showed the INTU to be a unidimensional construct, with most items located on the severe end of the symptom severity continuum. In addition to an Overall Impact Score (10 items), exploratory factor analysis affirmed by confirmatory factor analysis identified two domains: Daytime (six items) and Nighttime (four items) Impact Scores (comparative fit index = 0.968; root mean square error of approximation = 0.08). Concurrent validity met prespecified hypotheses, indicating similarity of concepts with the PSQI (correlation [r] = 0.627) and N-QOL (r = -0.784) total scores. The INTU differentiated among patients with different nocturic episode frequencies (P < 0.05 for all three summary scores). Statistically significant decreases were observed in mean Overall and Nighttime Impact Scores at week 2 versus week 1 in responders, indicating that the instrument can detect changes in response to symptom improvements. CONCLUSIONS: The INTU questionnaire demonstrated robust measurement properties and is a suitable tool for assessing the patient-reported impact of nocturia on health and functioning.