Nighttime Voiding Research Articles

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

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. Cross-sectional study. 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. 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. 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. Healthcare professionals should screen for nocturia in women with type 2 DM and provide appropriate management for those experiencing nocturia.

Prevalence, subtypes, and correlates of nocturia in the symptoms of Lower Urinary Tract Dysfunction Research Network cohort.

We determined the prevalence, severity, and correlates of nocturia in a large clinical cohort of patients. Patients presenting with lower urinary tract symptoms (LUTS) completed 3-day bladder diaries. Nocturia was quantified based on the mean number of nighttime voids documented over the 3 days. Nocturia subtypes (global polyuria, nocturnal polyuria [NP], reduced global bladder capacity, and reduced nocturnal bladder capacity) were assessed. Bother due to nocturia was measured by the LUTS Tool. Sleep quality was assessed with the Patient-Reported Outcomes Measurement Information System Sleep Scale. Multivariable multinomial regression was used to explore patient characteristics associated with nocturia. In 502 participants with analyzable diaries (285 men and 217 women), the mean number of nocturia episodes over 3 days was 0 in 103 (20.5%), >0 to <1 in 151 (20.1%), 1 to <2 in 165 (32.9%), and ≥2 in 83 (16.5%). Sixty-seven percent of the participants with nocturia ≥1 reported significant bother from their nocturia. NP was the most common nocturia subtype and was present in 17% of those with nocturia = 0, 40% of those with nocturia >0 to <1, 65% of those with nocturia 1 to <2%, and 77% with nocturia 2+. Higher degrees of nocturia were associated with male sex, greater sleep disturbance, and a higher likelihood of exhibiting multiple nocturia subtypes. Nocturia ≥1 occurred in 49% of LUTS patients and caused significant bother in the majority of them. The most common subtype was NP, but a substantial proportion of patients exhibited additional characteristics.

Normative noninvasive bladder function measurements in healthy women: A systematic review and meta-analysis.

To conduct an evidence synthesis of normative reference values for bladder function parameters in women. We conducted a systematic review and meta-analysis of studies reporting bladder function parameters obtained from noninvasive tests in healthy women. Seven databases were searched for relevant studies from inception through December 2018, with manual searching of reference lists. We included English language articles that provided quantitative data on urination frequency, voided and postvoid residual volumes, and uroflowmetry results in women without lower urinary tract symptoms. Study selection, data extraction, and quality assessment were undertaken by at least two independent reviewers. Random-effects meta-analytic models were used to derive study-level pooled mean estimates and 95% confidence intervals. A total of 24 studies (N = 3090 women, age range, 18-91 years) met eligibility criteria. Pooled mean estimates of bladder function parameters were: 6.6 daytime voids (95% confidence interval (95% CI), 6.2, 7.0), 0.4 nighttime voids (95% CI, 0.0, 0.8), 1577 mL for 24-hour voided volume (95% CI 1428,1725); 12 mL for postvoid residual volume (95% CI, 4, 20); and 28 mL/sec for maximum flow rate (95% CI, 27,30). Between-study heterogeneity was high for all outcomes (I2 = 61.1-99.6%), but insufficient data were available to explore reasons for this high heterogeneity (eg, differences by age). Although summary mean estimates of bladder function parameters were calculated, the wide heterogeneity across studies precludes generalization of these estimates to all healthy women. Further research is needed to determine normative reference values within specific groups, such as those defined by age.

The association of vulvar pain and urological urgency and frequency: findings from a community-based case-control study.

Vulvodynia is chronic debilitating burning vulvar pain or pain on contact. Although women who suffer from vulvodynia are more likely than others to experience co-morbid interstitial cystitis (IC) and urinary tract infections (UTIs), few studies have explored whether women with vulvodynia experience adverse urinary symptoms (lower urinary tract symptoms [LUTS]) in the absence of urological pain. Two hundred and eleven participants with and 226 participants without clinically confirmed vulvodynia completed the Pelvic Pain and Urgency/Frequency (PUF) questionnaire and were scored using all questions, and then a subset of questions relating only to their current frequency and bother of urination during day and night, and the frequency, severity and bother of urgency after voiding. Total, symptom, and bother scores were compared in women with and without vulvodynia, and regression models estimated adjusted odds ratios and 95% confidence intervals for the various LUTS symptoms. As expected, 40% of women with vulvodynia met the criteria for IC (PUF > 12) compared with 2% without vulvodynia. After excluding questions related to bladder or vulvovaginal pain, women with vulvodynia, compared with those without, were skewed toward higher PUF scores, including being 2.4 times more likely to report usually or always bothered by night-time voiding (95% CI 1.22-4.74), and 18 times more likely to report moderate/severe urgency after urination (95% CI 5.48-64.12). Women with vulvodynia are substantially more likely to report voiding dysfunction and symptoms of urgency than women with no history of vulvar pain. These findings are independent of comorbid interstitial cystitis or history of UTIs.

Longitudinal assessment of autonomic dysfunction in early Parkinson's disease

IntroductionClinical correlates of autonomic nervous system (ANS) dysfunction in early Parkinson's disease (PD) have been addressed mainly in a cross-sectional way. MethodsThis is a combined cross-sectional and longitudinal prospective study of ANS dysfunction using the SCOPA-AUT in PD patients at the Hoehn and Yahr stage 1 with disease duration <2 years. PD patients (n = 107) were compared to healthy controls (HC, n = 79), and then followed-up for over 3 years. The severity of PD, depression, anxiety, apathy and cognitive impairment were evaluated using rating scales. ResultsAt least one symptom of ANS dysfunction was present in 71% of PD patients in comparison to 30.4% of HC, and in all PD patients after three years. The overall severity of dysautonomia symptoms was mild (SCOPA-AUT mean ± SD; 4.16 ± 5.0), but worsened by 23%, 86% and 0.3% during the 1st, 2nd and 3rd year respectively. Nighttime voiding (38.3%), constipation (30.8%) and straining for defecation (29%) were the most common symptoms. Prevalence and severity of urinary, gastrointestinal, and orthostatic symptoms increased, in contrast to thermoregulatory and pupillomotor symptoms. Frequency of symptoms suggestive of multi-domain ANS dysfunction rose from 49% to 79%. Psychiatric symptoms and age, but not motor impairment, were associated with dysautonomia symptoms. ConclusionSymptoms of ANS dysfunction were frequent in the initial motor stage of PD and progressed, yet remaining mild, within 3 years. An independent progression of dysautonomia symptoms from motor disability and its associations with non-motor, mainly psychiatric symptoms and age support the non-motor clustering in PD.

Are night-time voiding and lower urinary tract symptoms significant risk factors for hip fractures caused by falling during the night in male subjects?

ObjectivesThe aim of our study was to assess the incidence of night-time voiding in a population of male patients with hip fracture, and to analyze the correlations between the severity of the lower urinary symptoms and the other most significant comorbidities of the patients.Patients and methodsWe have initially selected a group of patients containing all males admitted into a Department of Orthopedic Surgery with the diagnosis of hip fracture, with indication for replacement surgery, over a four-year period. Applying well-defined inclusion and exclusion criteria, we have selected all the patients who have reported that falling during the night, on the way to the toilet (for micturition), was the event leading to the hip fracture. A comprehensive medical history and the International Prostate Symptom Score (IPSS) Questionnaire were gathered from all the patients and the obtained data were analyzed.ResultsFrom a total of 363 patients with hip fractures, 68 cases were attributable to night-time voiding. The detailed analysis of the 68 patients has shown that all of them had significant nocturia (2.72 episodes of voiding per night, in average), but only 11 of them were already diagnosed with lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH). Moreover, only four of the eleven patients diagnosed with BPH were taking specific therapy at the moment of their falling leading to hip fracture. Subsequent analysis has shown that a group of 45 patients with no previously known co-morbidities, had similar IPSS score results with the total group of 68 patients.ConclusionsNight-time voiding and LUTS are underdiagnosed in the general male population, as they represent significant risk factors for hip fractures due to falling during the night. The low level of BPH/LUTS therapy adherence adds a supplementary risk for falling during the night.

45: Opiate use is associated with increased risk of treatment failure when using antimuscarinics for overactive bladder

To determine if opiate use affects treatment response to antimuscarinic medications for overactive bladder. We performed a retrospective nested cohort analysis of patients being treated with antimuscarinic medication for overactive bladder between January 2010 and December 2017. We included patients who were prescribed an antimuscarinic and subsequently had clear documentation of adherence and response to treatment. The primary outcome was reported treatment failure. Patients who were currently on opiates at the time of treatment were matched by age to controls without an opiate prescription within 1 year of antimuscarinic treatment at a ratio of 1:3. Differences between groups were evaluated using Wilcoxon Rank-Sum and Fisher’s exact test where appropriate. Logistic regression was used to control for confounders and identify predictors of the primary outcome. We identified 480 patients who met inclusion criteria. Opiate users were more likely to report constipation, have a remote history of urogynecologic surgery, a diagnosis of depression or anxiety, and to report treatment failure after taking antimuscarinic medication for overactive bladder (64.2% vs 48.1%, p=0.02). After controlling for confounders, opiate use was predictive of antimuscarinic treatment failure (aOR 1.9, 95% CI 1.17-3.06). Treatment failure was also correlated with active central nervous system disease, number of incontinence episodes per day, number of nighttime voids, and number of previously failed antimuscarinic medications. Opiate use is associated with an increased risk of treatment failure when using antimuscarinic medications for overactive bladder.

Multivariate analysis of long-term outcomes of storage symptom improvement in elderly patients with benign prostatic hyperplasia after GreenLight laser vaporization

Objective To investigate the relationship between preoperative urodynamic parameters and the improvement of overactive bladder(OAB)symptoms after GreenLight laser vaporization, and to explore prognostic factors for improvement of OAB symptoms in the elderly. Methods A retrospective study was conducted in 100 benign prostatic hyperplasia(BPH)patients undergoing GreenLight laser vaporization at the Department of Urology of Beijing Hospital from July 2015 to March 2017.All patients completed a preoperative urodynamic examination and received GreenLight laser vaporization.Clinical data including age, prostate-specific antigen(PSA), prostate volume, international prognostic scoring system(IPSS), overactive bladder symptom score(OABSS), quality of life(QOL)and urodynamic parameters were collected.The related factors for improvement of OAB symptoms after GreenLight laser vaporization were analyzed by a binary Logistic regression analysis. Results All patients underwent surgery successfully and completed a 12-month follow-up.Both urinary storage and voiding symptoms improved at 3 and 12 months after GreenLight laser vaporization(P<0.05). The scores of IPSS, IPSS storage(IPSS-S), IPSS voiding(IPSS-V), OABSS and QOL and nighttime voiding frequency decreased and urinary storage and voiding symptoms improved at 3 and 12 months after GreenLight laser vaporization, compared with pre-surgery data(P<0.05). The success rates of storage symptom improvement at 3 and 12 months after GreenLight laser vaporization were 62.0%(62/100)and 68.0%(68/100)evaluated by IPSS-S and 68.0%(68/100)and 75.0%(75/100)by OABSS, respectively.Multiple Logistic regression analysis showed that age, detrusor contractility, residual urine volume and nighttime voiding frequency were independent influencing factors for prognosis(OR=35.714, 0.352, 0.110 and 0.040, P=0.000, 0.027, 0.018 and 0.002). Conclusions GreenLight laser vaporization is an effective method in treating BPH with OAB.Age is an independent unfavorable factor and the residual urine volume, nighttime voiding frequency and detrusor contraction are independent influencing factors for prognosis.Enough attention should be paid to these related parameters before surgery. Key words: Prostatic hyperplasia; Urinary bladder, overactive

Increased odds of bladder and bowel symptoms in early Parkinson's disease.

To compare the prevalence of urinary and bowel symptoms in a sample of adults with early Parkinson's disease (PD) and healthy controls (HC). Data were obtained from the Michael J. Fox Parkinson's Progression Markers Initiative (PPMI). Prevalent bladder (urinary incontinence (UI) and nighttime voiding) and bowel (constipation and fecal incontinence (FI)) symptoms were defined as occurring at least sometimes when queried using the Scale for Outcomes in PD for Autonomic Symptoms. The proportion of men (65% vs 64%) and the mean age (61.0 ± 9.7 vs 60.2 ± 11.2 years) was similar between early PD (n = 423) and HC (n = 195). UI and constipation were more prevalent among early PD versus HC (UI: 26.7% vs 8.2%, constipation: 32.4% vs 11.8%; P's < 0.0001). Prevalent nighttime voiding was high among both groups, but not significantly different (82.5% vs 84.1%, P = 0.62). FI was infrequent in both. The odds of UI and constipation were significantly higher in early PD even after adjustment for age, sex, cognition, and overactive bladder (UI model only), constipation (UI and constipation models only), depression, and anxiety medication usage (UI: OR: 4.39 [95% CI: 2.92, 5.87]; constipation: 3.34 [2.20, 4.42]; P's < 0.0001). While constipation is known to precede PD diagnosis, these data suggest that the occurrence of UI is elevated in early PD compared to a well-matched HC population.

Patients' Lived Experiences of Nocturia: A Qualitative Study of the Evening, the Night, and the Next Day.

BackgroundNocturia, waking to urinate two or more times during the night, is a chronic condition associated with significant patient burden due to sleep disruption. This study aimed to explore the lived experiences of patients with nocturia in terms of the disruption to their lives during the night and day.MethodsAdult patients in the US diagnosed with nocturia were recruited for face-to-face qualitative interviews. Thematic analysis of patients’ narratives, taking a phenomenological interpretative approach, summarised their experiences throughout the night and day, including any apparent contrasts between patients.ResultsTwenty patients (10 male, 10 female) aged between 39 and 80 years, averaging three night-time voids, were interviewed. Analysis revealed that nocturia has a substantial impact on sleep quality and quantity, with the frequency of night-time voids a key driver of this. In addition to night-time phenomena, patients faced various difficulties the next day, including day-time tiredness, lack of energy and concerns related to emotional wellbeing, social functioning and cognitive functioning. All of these limited patients’ capacity to work, perform daily activities or fulfil role responsibilities. Patients’ lifestyles influenced experience, where younger patients in employment more readily emphasised the day-time physical and psychosocial burdens. Patients employed coping behaviours in an attempt to lessen the severity of nocturia and its impact, which were both physician-led and self-taught.ConclusionsWhile the symptom of nocturia only occurs during the night, the impact is longer lasting, affecting functioning and wellbeing throughout the following day. Patients’ circumstances can affect the extent of their burden; recognising this can improve effective delivery of patient-centred care.Electronic supplementary materialThe online version of this article (doi:10.1007/s40271-017-0241-0) contains supplementary material, which is available to authorized users.

Nocturia is often inadequately assessed, diagnosed and treated by physicians: results of an observational, real-life practice database containing 8659 European and US-American patients.

SummaryAimsThe aim of this study was to investigate the quality and timing of the diagnosis and treatment of nocturia in real‐life practice in European and US‐American patients to obtain better insights into the management of nocturia in different Western healthcare systems.MethodsData were drawn from the “LUTS Disease Specific Programme,” a real‐life survey of physicians and patients in France, Germany, Spain, UK and the USA. Physicians completed a patient record form for lower urinary tract symptoms (LUTS) patients. Patients filled out a self‐completion form, indicating – among other items – information on the mean number of day‐ and night‐time voids during the last 7 days, and questions on the management of LUTS in daily practice.ResultsIn total, 8659 patients were analysed. The majority of patients initially consulted a physician because of worsening of LUTS frequency (43%–58%) or severity (44%–55%). Only 37% of all LUTS diagnoses, regardless of the appearance or severity of nocturia, were based on bladder diaries. Patients took approximately 1 year to consult a medical professional following the onset of LUTS. At the initial visit, most patients received advice on behavioural strategies. Regardless the type of LUTS and physician, 59% of men received α‐blockers and 76% of women antimuscarinics.ConclusionsData show that patients with nocturia and LUTS accept their symptoms for a considerable period before they seek help or ultimately receive treatment. They may therefore be enduring significant negative impact on their quality‐of‐life which could be avoided. Physicians rarely use bladder diaries and primarily use antimuscarinics (women) or α‐blockers (men). Improved awareness of nocturia among patients and physicians could improve the management of nocturia.

Assessing the impact of nocturia on health-related quality-of-life and utility: results of an observational survey in adults

Background and aim: The impact of nocturia (getting up at night to void) on health-related quality-of-life (HRQoL) is often under-estimated. This study investigated the relative burden in terms of HRQoL and utilities of nocturia in a real-world setting.Methods: Patient data were collected from two surveys: a nocturia-specific, cross-sectional survey of physicians and their patients (DSP), and a general UK population health survey (HSFE). Utilities (EQ-5D-5L), productivity (Work Productivity and Activity Index), and the impact of nocturia symptoms (Nocturia Impact Diary and Overactive Bladder Questionnaires) were assessed against the number of voids. A robust linear regression model with propensity score weights was used to control for confounding factors in estimating utilities.Results: Physician-recorded data were available from 8,738 patients across the US, Germany, Spain, France, and the UK; of these, 5,335 (61%) included patient-reported outcomes. In total, 6,302 controls were drawn from the two surveys and compared to 1,104 nocturia patients. Deterioration of HRQoL was associated with increasing number of night-time voids (p < 0.0001). In particular, significant differences were observed between 0–1 and ≥2 voids (p < 0.001). The regression model demonstrated that nocturia (≥2 per night) is associated with a modest but significant deterioration in utility of 0.0134 (p < 0.05).Limitations: The cause of nocturia is multifactorial and the mostly elderly patients may have several concomitant diseases. The authors tried to adjust for the most common ones, but there may be diseases or unknown relationships not included.Conclusions: Nocturia negatively affected HRQoL and patient utility. A clear effect is seen already at two voids per night. Every effort should, therefore, be made to reduce nocturia below the bother threshold of two voids per night.

Overactive bladder - 18 years - Part I.

ABSTRACT : Overactive bladder syndrome is one of the lower urinary tract dysfunctions with the highest number of scientific publications over the past two decades. This shows the growing interest in better understanding this syndrome, which gathers symptoms of urinary urgency and increased daytime and nighttime voiding frequency, with or without urinary incontinence and results in a negative impact on the quality of life of approximately one out of six individuals – including both genders and almost all age groups. The possibility of establishing the diagnosis just from clinical data made patients' access to specialized care easier. Physiotherapy resources have been incorporated into the urological daily practice. A number of more selective antimuscarinic drugs with consequent lower adverse event rates were released. Recently, a new class of oral drugs, beta-adrenergic agonists has become part of the armamentarium for Overactive Bladder. Botulinum toxin injections in the bladder and sacral neuromodulation are routine modalities of treatment for refractory cases. During the 1st Latin-American Consultation on Overactive Bladder, a comprehensive review of the literature related to the evolution of the concept, epidemiology, diagnosis, and management was conducted. This text corresponds to the first part of the review Overactive Bladder 18-years.

Prospective Randomized Crossover Trial Comparing Continuous and Cyclic Stimulation in InterStim Therapy

The aim of this study was to assess a difference in efficacy and patient preference in cyclic versus continuous stimulation with InterStim therapy for urge incontinence or urinary frequency. Patients with refractory urge incontinence/urinary frequency and with recent implantation of the InterStim system were randomized to continuous or cyclic InterStim stimulation after institutional review board-approved consent. They completed a 3-day voiding diary after 1 month of stimulation. They were then switched to the alternative setting for 1 month and completed another voiding diary. Subjective responses were evaluated with the Urinary Incontinence Impact Questionnaire and the Urinary Distress Inventory. Patient preference of stimulation setting was assessed. Statistical analysis was performed with paired t tests and repeated-measures analysis of variance. Data were available for 32 patients. Indication for InterStim: urge incontinence = 24, frequency = 8. No differences were noted in the number of urgency or urge incontinence episodes (mild, moderate, severe, or total) with cyclic or continuous stimulation. No differences were noted in the number of number of pads per day or the number of daytime or nighttime voids. The Urinary Incontinence Impact Questionnaire and Urinary Distress Inventory symptoms scores showed no significant differences between cyclic and continuous stimulation. No significant difference was noted in measured parameters based on the order of stimulation. Continuous stimulation was preferred by 17 patients, 9 preferred cyclic stimulation, and 6 had no preference. No significant differences were noted in voiding diaries and subjective responses between cyclic and continuous stimulation in InterStim therapy for patients with urge incontinence or frequency.

Comprehensive Health-Related Quality of Life is Influenced by Nocturia and Sleep Disturbance: Investigation Based on the SF-8.

We investigated the influence of nocturia and sleep disturbance on health-related quality of life(HRQOL) using the Medical Outcomes Study 8-item Short Form Health Survey (SF-8) in patients with nocturia. We also assessed the effect of therapeutic intervention by means of an anticholinergic agent on the results of the SF-8. One hundred and eighty-four patients who voided at least once per night were surveyed using the SF-8, Overactive Bladder Symptom Score (OABSS), Pittsburgh Sleep Quality Index (PSQI), and Epworth Sleepiness Scale (ESS). These parameters were also evaluated before and after 12 weeks of imidafenacin treatment in 51 patients with OAB accompanied by nocturia. The SF-8 physical component summary score (PCS) showed a significant decrease as nighttime voiding frequency increased. The mental health component summary score was 47.1 and 47.6 (which were lower than the standard value of 50) in the group with a nighttime frequency of once and ≥3/night, respectively. The SF-8 PCS and 6 subscales were negatively associated with nighttime voiding frequency, while the PSQI global score was positively associated with it. Imidafenacin significantly improved the OABSS, PSQI, and ESS, as well as the SF-8 score. This is the first study using the SF-8 to show that nocturia and sleep disturbance have a major influence on comprehensive HRQOL and that the SF-8 can be used to monitor HRQOL in OAB patients receiving treatment for nocturia.

Management of nocturia: the role of antidiuretic pharmacotherapy.

Strategies to manage nocturia include lifestyle modifications and treatment with alpha-blockers, antimuscarinic therapies, and antidiuretics. The concept of achieving success should not be limited to reduction of nighttime voids; it should ideally include proof of improvement of conditions generally associated with nocturia, such as falls, quality of life, and overall health. Few studies have looked specifically at parameters other than nocturnal voids, such as sleep latency, first undisturbed sleep period (FUSP), and total sleep time, including their clinical relevance to patient well-being. Lifestyle modifications, such as voiding before bedtime, limiting caffeine and alcohol, and adjusting medication timing, may be initially effective in mild cases of nocturia. Statistically significant reductions in voiding have been reported with antimuscarinic agents and alpha-blockers as initial therapy, but these reductions generally are not clinically relevant. The antidiuretic therapy desmopressin acetate, a selective vasopressin receptor 2 agonist, is effective in adults with nocturia associated with nocturnal polyuria; however, hyponatremia can occur. The newest formulation-desmopressin orally disintegrating sublingual tablet (ODST)--has greater bioavailability; thus, lower doses can be used, potentially reducing hyponatremia risk. A phase 3 study demonstrated statistically significant reductions in nocturnal voids for desmopressin ODST 50 and 100 µg versus placebo (-1.18 and -1.43 vs. -0.86; P = 0.02 and P < 0.0001, respectively) in patients with nocturia. Treatment was well-tolerated, and low-dose desmopressin ODST was associated with statistically significant increases in duration of FUSP. Development of a validated composite endpoint may help clinicians identify and compare strategies for treating nocturia.

Effects of tadalafil on nighttime voiding (nocturia) in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia: a post hoc analysis of pooled data from four randomized, placebo-controlled clinical studies

The phosphodiesterase type 5 inhibitor tadalafil is approved for the treatment of signs and symptoms of benign prostatic hyperplasia (BPH). While tadalafil significantly improves overall lower urinary tract symptoms suggestive of BPH (LUTS/BPH), improvements in nocturia were not significant in individual studies. We therefore sought to further assess nocturia based on data integrated from four tadalafil registrational studies. Data were integrated from four randomized, placebo-controlled, double-blind, 12-week registrational studies of tadalafil for LUTS/BPH. Nocturia was assessed as nighttime voiding frequency using the International Prostate Symptom Score question 7 (IPSS Q7). Efficacy results were analyzed using analysis of covariance. For the tadalafil 5 mg once daily (N = 752) and placebo (N = 748) groups, baseline characteristics were well balanced, and the overall severity of nocturia per mean IPSS Q7 was 2.3 ± 1.2. The mean treatment change was -0.4 with placebo and -0.5 with tadalafil; the least-squares mean (standard error) treatment difference was -0.2 (0.05), p = 0.002. For patients receiving placebo and tadalafil, respectively, the proportion with improved nocturnal frequency was 41.3 and 47.5 %, with no change was 44.8 and 41.0 %, and with worsening was 13.9 and 11.5 %. A statistically significant improvement in nocturnal frequency was seen with tadalafil over placebo; however, the treatment difference was small and not considered clinically meaningful. Further studies using voiding diaries and excluding patients with nocturnal polyuria would be needed to more precisely estimate the impact of tadalafil on nocturia associated with LUTS/BPH.

Consistent and significant improvement of nighttime voiding frequency (nocturia) with silodosin in men with LUTS suggestive of BPH: pooled analysis of three randomized, placebo-controlled, double-blind phase III studies

Nocturia is prevalent and bothersome in men with lower urinary tract symptoms suggestive of BPH (LUTS/BPH). α-Adrenoceptor antagonists without subtype selectivity have inconsistently shown significant effects on nocturia in these patients. We explored the effects of the α1A-adrenoceptor subtype-selective antagonist silodosin on nocturia by analyzing three placebo-controlled registration studies. Responses to question 7 of the IPSS questionnaire were analyzed for the entire study population and patients with ≥ 2 voids/night at baseline. Improvement/worsening rates for nocturia were calculated for once-daily silodosin 8 mg and placebo. Silodosin effects on the mean number of nocturnal voids were compared with placebo, and the number of patients in whom nocturia was reduced to <2 times was calculated. In total, 1,479 men were treated with silodosin or placebo; 1,266 men (85 %) had ≥ 2 voids/night at baseline. Compared to placebo, more men treated with silodosin reported about nocturia improvement (53.4 vs. 42.8 %, p < 0.0001) and fewer patients about worsening (9.0 vs. 14.3 %, p < 0.0001). Silodosin significantly reduced nocturia within each study and pooled cohort compared to placebo (p < 0.001). In men with ≥ 2 nocturnal voids at baseline, 61 and 49 % of patients with silodosin and placebo had reductions of ≥ 1 voids/night, respectively (p = 0.0003), and significantly more patients with silodosin had <2 nocturia episodes at study end compared to placebo (29.3 vs. 19.0 %; p = 0.0002). Although a weak impact on nocturia is already known from α-adrenoceptor antagonists without subtype selectivity, the individual placebo-controlled studies and the pooled data analysis showed that the α1A-adrenoceptor subtype-selective antagonist silodosin consistently and significantly improves nocturia in men with LUTS/BPH.

Nocturia Quality‐of‐Life questionnaire is a useful tool to predict nocturia and a risk of falling in Japanese outpatients: A cross‐sectional survey

To evaluate the Japanese version of the Nocturia Quality-of-Life questionnaire for prediction of night-time voiding and risk of falling. A survey was carried out from October 2008 to June 2009 in outpatients at 15 general hospitals and 80 general clinics in Tochigi, Japan, using the Nocturia Quality-of-Life questionnaire, overactive bladder symptom score and self-administered questionnaires on night-time symptoms (awakening, number of voids, incontinence and falling). The survey was completed by 2494 participants (1154 men, 1208 women; mean age 63.2 ± 15.1 years). Overactive bladder was diagnosed in 625 participants (25.1%) according to the Japanese overactive bladder guideline using overactive bladder symptom score. Awakening during sleep was reported by 80.1% of the participants, and 70.4% awakened to go to the toilet. The mean Nocturia Quality-of-Life score was 86.8 ± 16.9. The Nocturia Quality-of-Life score was lower in patients with overactive bladder, benign prostatic hyperplasia, diabetes, hypertension and cardiovascular diseases. The Nocturia Quality-of-Life score was significantly decreased in patients with night-time symptoms (P < 0.001). Nocturia Quality-of-Life scores and those for subdomains were correlated with overactive bladder symptom score. Nocturia Quality-of-Life ≤90 had 63.1% sensitivity and 78.6% specificity in indicating night-time voiding more than twice, and Nocturia Quality-of-Life questionnaire ≤80 had 70.2% sensitivity and 79.5% specificity in indicating the probability of falling at least once. Logistic analysis showed that 10-year increase in age and overactive bladder in all participants were significant risk factors for Nocturia Quality-of-Life ≤90. The Nocturia Quality-of-Life questionnaire represents a useful tool to predict nocturia and risk of falling in Japanese patients.

Imidafenacin, an Antimuscarinic Agent, Improves Nocturia and Reduces Nocturnal Urine Volume

To evaluate the efficacy of imidafenacin for nocturia and nocturnal polyuria in patients with overactive bladder. A stratified analysis was conducted on data from a phase III randomized, double-blind, controlled trial of imidafenacin performed at 158 centers in Japan. The subjects received imidafenacin (0.1 mg) twice daily (group I) or placebo twice daily (group P). The 24-hour urine volume, daytime and nighttime voiding frequency, and volume voided/micturition were evaluated from 3-day voiding diaries recorded every 4 weeks during the 12-week study period. Longitudinal data analysis was performed, with all values expressed as the least squares mean ± standard error. A total of 46 patients (mean age 66.54 ± 9.38 years, 9 men and 37 women) with nocturia and nocturnal polyuria (>33% of urine production at night) were enrolled. Group I (n = 35) and group P (n = 11) showed no baseline differences in the daily voided volume, concomitant diseases, age, or body weight. However, the average daily number of micturitions differed (11.22 ± 2.17 vs 14.45 ± 2.85). Therefore, longitudinal data analysis was performed for each micturition pattern. After 12 weeks of treatment, nighttime micturition was significantly less frequent in group I than in group P (P = .0292), and the nocturnal percentage of 24-hour production was significantly smaller (P = .0053). The interval to the first nighttime void was significantly longer in group I than in group P, but no difference was found in the first nighttime voided volume. The novel antimuscarinic agent, imidafenacin, decreases the number of urinations and reduces nocturnal urine production, thereby improving both nocturia and nocturnal polyuria.