The association between nocturia, hormonal symptoms and bladder parameters in women: an observational study.

OBJECTIVE: Postmenopausal nocturia is poorly understood. This study aimed to identify hormonal and lifestyle factors associated with nocturia and to understand the relative contribution of altered urine production and bladder storage dysfunction in women. DESIGN, SETTING, POPULATION AND METHODS: Women ≥40 years presenting to public continence services were enrolled in a cross-sectional study. A total of 153 participants completed a hormone status questionnaire, a validated nocturia causality screening tool and a 3-day bladder diary. Descriptive statistics and logistic regression models for nocturia severity and bladder diary parameters were computed. RESULTS: Overall, 91.5% reported nocturia, 55% ≥2 /night. There was a difference of 167.5 ml (P < 0.001) in nocturnal urine volume between women with nocturia ≥2 (median 736 ml) versus less often (517 ml). Significant predictors of self-reported disruptive nocturia were age (odds ratio [OR] 1.04, 95% CI 1.002-1.073) and vitamin D supplementation (OR 2.33, 95% CI 1.11-4.91). Nocturnal polyuria was significantly more common with nocturia ≥2 compared with less frequent nocturia (P < 0.002). Exercise for 150 minutes a week was protective for nocturnal polyuria (OR 0.22, P = 0.001). Nocturia index >1.3 was significantly predicted by age (OR 1.07, P < 0.001), regular exercise (OR 0.41, P = 0.036), day flushes (OR 4.00, P = 0.013) and use of vitamin D (OR 2.34, P = 0.043). Maximum voided volumes were significantly lower with nocturia ≥2 versus less often (night: 268 ml versus 350 ml; day: 200 ml versus 290 ml). CONCLUSIONS: Bothersome nocturia in postmenopausal women is associated with changes to both nocturnal diuresis and bladder storage. Regular physical activity, prolapse reduction and oestrogen replacement may be adjunctive in managing bothersome nocturia in women.

The effects of choreito on a model of nocturnal polyuria using Dahl salt-sensitive rats.

OBJECTIVES: This study aimed to determine whether Dahl salt-sensitive rats fed a high-salt diet would show features of nocturia due to nocturnal polyuria and to examine the efficacy of choreito (CRT) on nocturnal polyuria. METHODS: Dahl salt-sensitive rats were divided into three groups. Group A was fed a 4% salt diet, group B a 2% salt diet, and group C a normal 0.3% salt diet. In groups α and ß, other rats were further divided into two groups: The rats in group α were fed a 2% salt plus 3% CRT diet, and those in group ß, were fed a 2% salt diet. Each rat was placed in an individual metabolic cage for 24 hours every week for 6 weeks. Water intake, urine production, voiding frequency, and voided volume per micturition were recorded. RESULTS: The systolic blood pressure increased in the group fed a 4% salt diet compared to groups fed with a 2% and 0.3% salt diet. The urinary volume was higher in the groups fed with 4% and 2% salt than in the group fed with 0.3% salt. Further, water intake in the group fed a 2% salt plus 3% CRT diet was significantly lower than that in the group fed with a 2% salt diet. CONCLUSIONS: Dahl salt-sensitive rats fed a 2% salt diet were candidates for a model of nocturnal polyuria. Using this model, we suggest that CRT reduces water intake in the active phase and contributes to water restriction in the treatment of nocturnal polyuria.

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.

Jingui Shenqi pill for nocturia due to nocturnal polyuria: A protocol for systematic review and meta-analysis.

BACKGROUND: The incidence of nocturia is high and will seriously affect patients' physical and mental health. Nocturnal polyuria is the most critical cause of nocturia, There are few drugs currently used to treat nocturia due to Nocturnal Polyuria (NP). The guide highly recommends only Desmopressin. There is an urgent need to find new drugs. Jingui Shenqi pill (JSP) is a Chinese patent medicine, it is widely used in China to treat NP. However, there is no evidence-based medical evidence to prove its safety and effectiveness. The purpose of this systematic review is to evaluate the efficacy and safety of JSP in the treatment of NP. METHODS: We will search the randomized controlled trials (RCTs) including JSP for NP and published from the inception of the database to Oct 2020 by the following eight databases: Embase, Cochrane Library, PubMed, MEDLINE, the China National Knowledge Infrastructure, Cqvip Database, and Wanfang Data, the Chinese Biomedical Literature Database. There is no language and publication status restriction. The primary outcomes will include Nocturnal urine volume, the number of nocturnal voids, Nocturnal polyuria index (Nocturnal total urine volume /24 h total urine volume). We will perform the data synthesis, sensitivity analysis, subgroup analysis, and bias assessment risk using RevMan V.5.3. The reporting bias will be assessed using a funnel plot and Egger test. RESULTS: This study may provide additional evidence of JSP for NP in the effectiveness and safety and alternative therapy for NP. CONCLUSIONS: In this systematic review, we will assess whether JSP is an effective and safe medicine for nocturia.

Stereotactic Body Radiation Therapy for Intermediate-risk Prostate Cancer With VMAT and Real-time Electromagnetic Tracking: A Phase II Study.

OBJECTIVES: Stereotactic body radiation treatment represents an intriguing therapeutic option for patients with early-stage prostate cancer. In this phase II study, stereotactic body radiation treatment was delivered by volumetric modulated arc therapy with flattening filter free beams and was gated using real-time electromagnetic transponder system to maximize precision of radiotherapy and, potentially, to reduce toxicities. MATERIALS AND METHODS: Patients affected by histologically proven prostate adenocarcinoma and National Comprehensive Cancer Network (NCCN) intermediate class of risk were enrolled in this phase II study. Beacon transponders were positioned transrectally within the prostate parenchyma 7 to 10 days before simulation computed tomography scan. The radiotherapy schedule was 38 Gy in 4 fractions delivered every other day. Toxicity assessment was performed according to Common Terminology Criteria for Adverse Events (CTCAE), v4.0. RESULTS: Thirty-six patients were enrolled in this study. Median initial prostate-specific antigen was 7.0 ng/mL (range: 2.3 to 14.0 ng/mL). Median nadir-prostate-specific antigen after treatment was 0.2 ng/mL (range: 0.006 to 4.8 ng/mL). A genitourinary acute toxicity was observed in 21 patients (dysuria grade [G] 1: 41.7%, G2: 16.7%). Gastrointestinal acute toxicity was found in 9 patients (proctitis G1: 19.4%, G2: 5.6%). Late toxicity was mild (genitourinary toxicity G1: 30.6%; G2: 8.3%; gastrointestinal toxicity G1: 13.9%; G2: 19.4%). At a median follow-up time of 41 months, 3 biochemical recurrences were observed (2 local recurrences, 1 distant metastasis). Three-year biochemical recurrence-free survival was 89.8% (International Society of Urologic Pathology Grade Group 2: 100%, Grade Group 3: 77.1%, P=0.042). CONCLUSION: Ultrahypofractionated radiotherapy, delivered with flattening filter free-volumetric modulated arc therapy and gated by electromagnetic transponders, is a valid option for intermediate-risk prostate cancer.

Interpersonal Trauma as a Marker of Risk for Urinary Tract Dysfunction in Midlife and Older Women.

OBJECTIVE: To examine relationships between interpersonal trauma exposures and urinary symptoms in community-dwelling midlife and older women. METHODS: We analyzed cross-sectional data from a multiethnic cohort of women aged 40-80 years enrolled in an integrated health care system in California. Lifetime history of intimate partner violence (IPV) and sexual assault, current posttraumatic stress disorder (PTSD) symptoms, and current urinary symptoms were assessed using structured-item questionnaires. Multivariable-adjusted logistic regression models examined associations between traumatic exposures and PTSD symptoms with any weekly urinary incontinence, stress-type incontinence, urgency-type incontinence, and nocturia two or more times per night. RESULTS: Of the 1,999 participants analyzed, 21.7% women reported lifetime emotional IPV, 16.2% physical IPV, 19.7% sexual assault, and 22.6% reported clinically significant PTSD symptoms. Overall, 45% reported any weekly incontinence, 23% stress-type incontinence, 23% urgency-type incontinence, and 35% nocturia. Exposure to emotional IPV was associated with any weekly incontinence (odds ratio [OR] 1.33, 95% CI 1.04-1.70), stress-type incontinence (OR 1.30, 95% CI 1.00-1.65), urgency-type incontinence (OR 1.30, 95% CI 1.00-1.70), and nocturia (OR 1.73, 95% CI 1.36-2.19). Physical IPV exposure was associated with nocturia (OR 1.35, 95% CI 1.04-1.77), but not incontinence. Sexual assault history was not associated with weekly incontinence of any type or nocturia. Symptoms of PTSD were associated with all urinary symptoms assessed, including any weekly incontinence (OR 1.46, 95% CI 1.15-1.85), stress-type incontinence (OR 1.70, 95% CI 1.32-2.20), urgency-type incontinence (OR 1.60, 95% CI 1.24-2.06), and nocturia (OR 1.95, 95% CI 1.55-2.45). CONCLUSION: More than 20% of women in this multiethnic, community-based cohort reported a history of IPV, PTSD symptoms, or both, which were associated with symptomatic urinary tract dysfunction. Findings highlight the need to provide trauma-informed care of midlife and older women presenting with urinary symptoms.

Beyond the bladder: poor sleep in women with overactive bladder syndrome.

BACKGROUND: Nocturnal bladder symptoms and sleep disruption commonly coexist in middle-aged and older women. Although sleep disruption is often attributed to nocturnal bladder symptoms in women with overactive bladder syndrome, nonbladder factors also may influence sleep in this population. Many women with overactive bladder are eager to identify nonpharmacologic strategies for both bladder symptoms and sleep disruption, given the potential adverse effects of sedative and anticholinergic bladder medications in this population. OBJECTIVES: To provide greater insight into the complex relationship between nighttime overactive bladder symptoms and sleep disruption, and to evaluate the effects of a guided slow-paced respiration intervention on sleep outcomes in women with overactive bladder. STUDY DESIGN: We conducted an ancillary study within a randomized trial of slow-paced respiration in women with overactive bladder symptoms. Ambulatory community-dwelling women who reported ≥3 episodes/day of urgency-associated voiding or incontinence were randomized to use either a portable biofeedback device (RESPeRATE; Intercure, Ltd) to practice guided slow-paced respiration exercises daily for 12 weeks (N=79) or an identical-appearing device programmed to play nonrhythmic music without guiding breathing (N=82). At baseline and after 12 weeks, bladder symptoms were assessed by voiding diary, sleep duration, and disruption were assessed by sleep diary corroborated by wrist actigraphy, and poor sleep quality was determined by a Pittsburgh Sleep Quality Index global score >5. RESULTS: Of the 161 women randomized, 31% reported at least twice-nightly nocturia, 26% nocturnal incontinence, and 70% poor sleep quality at baseline. Of the 123 reporting any nighttime awakenings, 89% averaged 1 or more nighttime awakenings, and 83% attributed at least half of awakenings to using the bathroom. Self-reported wake time after sleep onset increased with increasing frequency of nocturnal bladder symptoms (P=.01 for linear trend). However, even among women without nocturia, average sleep quality was poor (Pittsburg Sleep Quality Index global score mean of 7.3; 95% confidence interval, 6.0-8.6). Over 12 weeks, women assigned to slow-paced respiration (N=79) experienced modest improvements in mean nocturnal voiding frequency (0.4 fewer voids/night), sleep quality (1.1 point score decrease), and sleep disruption (1.5% decreased wake time after sleep onset). However, similar improvements were detected in the music control group (N=81), without significant between-group differences. CONCLUSIONS: Many women with overactive bladder syndrome experience disrupted sleep, but not all nocturnal awakenings are attributable to bladder symptoms, and average sleep quality tends to be poor even in women without nocturia. Findings suggest that clinicians should not assume that poor sleep in women with overactive bladder syndrome is primarily caused by nocturnal bladder symptoms. Guided slow-paced respiration was associated with modest improvements in nocturia frequency and sleep quality in this trial, but the results do not support clinician recommendation to use this technique over other behavioral relaxation techniques for improving sleep.

Does cranberry extract reduce antibiotic use for symptoms of acute uncomplicated urinary tract infections (CUTI)? Protocol for a feasibility study.

BACKGROUND: Consultations in primary care for symptoms of urinary tract infections (UTIs) are common and patients are frequently treated with antibiotics. Given increasing antimicrobial resistance, there has been interest in non-antibiotic treatment options for common infections. One such option is the use of cranberry extract to treat symptoms attributable to UTIs. METHODS: A target of 45 women consulting in primary care, with symptoms suggestive of an uncomplicated UTI for whom the practitioner would normally prescribe antibiotics, will be randomised to receive one of three treatment approaches: (1) immediate prescription for antibiotics; (2) immediate prescription for antibiotics plus a 7-day course of cranberry capsules and (3) cranberry capsules plus a delayed prescription for antibiotics to be used in case their symptoms do not get better, or get worse. Follow-up will be by daily rating of symptoms and recording of treatments used for 2 weeks in an online symptom diary. Interviews will be conducted with around 10-15 study participants, as well as with around 10-15 women who have experienced a UTI but have not been approached to take part in the study. Both groups will be asked about their experience of having a UTI, their thoughts on non-antibiotic treatments for UTIs and their thoughts on, or experience of, the feasibility trial. The primary objective is to assess the feasibility of undertaking a full trial in primary care of the effectiveness of cranberry extract to reduce antibiotic use for symptoms of acute uncomplicated UTI. The secondary objective is to conduct a preliminary assessment of the extent to which cranberry might reduce antibiotic use and symptom burden. DISCUSSION: This feasibility study with embedded interviews will inform the planning and sample size calculation of an adequately powered trial to definitively determine whether cranberry helps to alleviate the symptoms of acute uncomplicated UTIs in women and whether it can safely reduce antibiotic use. TRIAL REGISTRATION: ISRCTN registry, ID: 10399299. Registered on 24 January 2019.

Metabolic syndrome and smoking are associated with persistence of nocturia after transurethral resection of the prostate.

AIMS: The aim of our study was to evaluate the relationship between smoking, metabolic syndrome (MetS) and persistence of nocturia in patients with moderate/severe nocturia (nocturia episodes ≥2), lower urinary tract symptoms (LUTSs), and benign prostatic enlargement (BPE) undergoing transurethral resection of the prostate (TURP). METHODS: From 2015 onward, a consecutive series of patients with moderate/severe nocturia (nocturia episodes ≥2), LUTS, and BPE undergoing TURP were prospectively enrolled. Medical history, physical examination, and smoking status were recorded. MetS was defined according to Adult Treatment Panel III. Moderate/severe persistent nocturia after TURP was defined as nocturia episodes ≥2. Binary logistic regression analysis was used to evaluate the risk of persisting nocturia. RESULTS: One hundred two patients were enrolled with a median age of 70 years (interquartile range: 65/73). After TURP, moderate/severe nocturia was reported in 43 of 102 (42%) of the patients. Overall 40 of 102 (39%) patients presented a MetS, and out of them, 23 of 40 (58%) presented a moderate/severe persistent nocturia after TURP ( P = .001). Overall 62 of 102 (61%) patients were smokers, and out of them, 32 of 62 (52%) presented moderate/severe persistent nocturia after TURP ( P = .034). On multivariate analysis, prostate volume, MetS, and smoking were independent risk factors for moderate/severe persistent nocturia after TURP. CONCLUSION: In our single-center study, MetS and smoking increased the risk of moderate/severe persistent nocturia after TURP in patients with LUTS-BPE. Although these results should be confirmed, and the pathophysiology is yet to be completely understood, counseling smokers and MetS patients about the risk of postoperative persistent nocturia is warranted.

Gentle Perineal Skin Stimulation for Control of Nocturia.

One of the major causes of nocturia is overactive bladder (OAB). Somatic afferent nerve stimuli are used for treating OAB. However, clinical evidence for the efficacy of this treatment is insufficient due to the lack of appropriate control stimuli. Studies on anesthetized animals, which eliminate emotional factors and placebo effects, have demonstrated an influence of somatic stimuli on urinary bladder functions and elucidated the underlying mechanisms. In general, the effects of somatic stimuli are dependent on the modality, location, and physical characteristics of the stimulus. Recently we showed that gentle stimuli applied to the perineal skin using a soft elastomer roller inhibited micturition contractions to a greater extent than a roller with a hard surface. Studies aiming to elucidate the neural mechanisms of gentle stimulation-induced inhibition reported that 1-10 Hz discharges of low-threshold cutaneous mechanoreceptive Aß, Aδ, and C fibers evoked during stimulation with an elastomer roller inhibited the micturition reflex by activating the spinal cord opioid system, thereby reducing both ascending and descending transmission between bladder and pontine micturition center. The present review will provide a brief summary of (1) the effect of somatic electrical stimulation on the micturition reflex, (2) the effect of gentle mechanical skin stimulation on the micturition reflex, (3) the afferent, efferent, and central mechanisms underlying the effects of gentle stimulation, and (4) a translational clinical study demonstrating the efficacy of gentle skin stimuli for treating nocturia in the elderly with OAB by using the two roller types inducing distinct effects on rat micturition contractions. Anat Rec, 302:1824-1836, 2019. © 2019 American Association for Anatomy.

Novel immediate/sustained-release formulation of acetaminophen-ibuprofen combination (Paxerol®) for severe nocturia associated with overactive bladder: A multi-center, randomized, double blinded, placebo-controlled, 4-arm trial.

AIM: To determine short-term efficacy and safety of Paxerol®, novel immediate:sustained (50%:50%) release tablets containing 325 mg acetaminophen and 150 mg ibuprofen per tablet. METHODS: One of three dose levels, corresponding to the amounts in 1, 2, and 3 tablets, of Paxerol and placebo were administered for 14 consecutive days to patients with severe nocturia (defined in this study as an average nocturnal voids [NV] ≥2.5) associated with overactive bladder (OAB). Changes in NV, as well as Nocturia Quality of Life (NQOL), duration of first uninterrupted sleep (DFUS), and total hours of nightly sleep (THNS) associated with treatment were assessed. Short-term safety/tolerability was assessed throughout the study and for at least 30 days post-treatment. RESULTS: Paxerol at all three doses reduced NV to a greater degree than placebo (average NV -1.1, -1.4, -1.3 voids for low, mid, and high doses, respectively, vs -0.3 void for placebo). NQOL and THNS were similar between baseline and treatment values in all four groups. There were also no between-group differences. Paxerol at high dose tended to (although not statistical significantly) increase DFUS to a greater degree than placebo (1.2 vs 0.4 h, P = 0.057). There were no treatment related adverse events in any of the four groups. CONCLUSIONS: This study demonstrates short-term efficacy and short-term safety of Paxerol in patients with severe nocturia associated with OAB. The results warrant further investigation of the long-term efficacy and safety of Paxerol in larger patient populations.

[Nocturia in men with benign prostatic hyperplasia]. / Nykturie beim Benignen Prostatasyndrom.

Nocturia, defined as nocturnal micturition with a frequency of at least once per night, is one of the most frequent lower urinary tract symptoms in men with benign prostatic hyperplasia (BPH) and often causes them to consult a physician. Nocturia is often bothersome and responsible for increased morbidity and mortality. Nocturia can be caused by increased fluid intake, increased diuresis or decreased bladder capacity, either alone or in combination. The underlying pathophysiology of nocturia can only be detected by methodical evaluation of the patient. Bladder diaries for 3 days are an essential part of the assessment. Treatment goals include reducing the nocturnal voiding frequency to less than 2 episodes per night, increasing the duration of undisturbed sleep to more than 4 hours, restoring quality of life, and reducing morbidity as well as mortality. In patients with reduced functional bladder capacity, α-blockers, 5α-reductase inhibitors, phosphodiesterase type-5 inhibitors, plant extracts or prostate operations (e. g. TURP) have shown to significantly reduce nocturnal voiding frequency. If nocturnal polyuria causes or contributes to nocturia, as shown in up to 80 % of BPH patients with nocturia, the treatment goal is to reduce urine production during the night. Low nocturnal serum concentration of the antidiuretic hormone can be treated with desmopressin to be taken at bedtime. The risk of hyponatremia is reduced with the new low-dose desmopressin formulation, which can be used even in men older than 65 years of age. Drug combinations may be useful in men with a mixed pathophysiology of nocturia.

High-power Magnetotherapy: A New Weapon in Urinary Incontinence?

OBJECTIVE: Urinary incontinence (UI) is one of the most common urinary system diseases that mostly affects women but also men. We evaluated the therapeutic efficacy of functional magnetic stimulation (FMS) as potential UI treatment with improvements in the pelvic floor musculature, urodynamic tests and quality of life. METHODS: A total of 20 UI patients (10 females and 10 men, mean age 64, 14 years), including 10 with stress UI, four with urgency UI and six with mixed UI, were treated with FMS (20 min/session) twice a week for 3 weeks. The patients' impressions, records in urinary diaries, and scores of three life stress questionnaires (overactive bladder symptom questionnaire [OAB-q], urogenital distress inventory questionnaire-short form [UDI-6], incontinence impact questionnaire-short form [IIQ-7]) were performed pre- and post-treatment. RESULTS: Significant reductions (P < 0.01) of micturition number and nocturia after magnetic treatment were evidenced. The urodynamic tests recorded a significant increase in cystometric capacity (147 ± 51.3%), in maximum urethral closure pressure (110 ± 34%), in urethral functional length (99.8 ± 51.8%), and in pressure transmission ratio (147 ± 51.3%) values compared with the baseline values. CONCLUSIONS: These preliminary findings suggest that FMS with Magneto STYM (twice weekly for 3 weeks) improves the UI and may be an effective treatment for this urogenital disease.

Protocol for a randomized, double blind, placebo controlled, crossover trial of Melatonin for treatment of Nocturia in adults with Multiple Sclerosis (MeNiMS).

BACKGROUND: Nocturia (the symptom of needing to wake up to pass urine) is common in progressive Multiple Sclerosis (MS) patients. Moderate-to-severe nocturia affects quality of life, can exacerbate fatigue and may affect capacity to carry out daily activities. Melatonin is a natural hormone regulating circadian cycles, released by the pineal gland at night-time, and secretion is impaired in MS. Melatonin levels can be supplemented by administration in tablet form at bedtime. The aim of this study is to evaluate the effect of melatonin on mean number of nocturia episodes per night in MS patients. Secondary outcome measures will assess impact upon quality of life, urinated volumes, lower urinary tract symptoms (LUTS), cognition, sleep quality and sleep disturbance of partners. METHODS: A randomized, double blind, placebo controlled, crossover trial consisting of two, six week treatment phases (active drug melatonin 2 mg or placebo), with a 1 month wash-out period in between. The primary outcome (change in nocturia episodes per night) in this two arm, two treatment, two period crossover design, will be objectively measured using frequency volume charts (FVC) at baseline and following both treatment phases. Questionnaires will be used to assess quality of life, sleep quality, safety and urinary tract symptoms. Qualitative interviews of participants and partners will explore issues including quality of life, mechanisms of sleep disturbance and impact of nocturia on partners. DISCUSSION: This study will evaluate whether melatonin reduces the frequency of nocturia episodes in MS patients, and therefore whether 'Circadin' has the potential to reduce LUTS and fatigue, and improve cognition and overall quality of life. TRIAL REGISTRATION: (EudraCT reference) 2012-00418321 registered: 25/01/13. ISRCTN Registry: ISRCTN38687869.

Fixed-dose combination PRO 160/120 of sabal and urtica extracts improves nocturia in men with LUTS suggestive of BPH: re-evaluation of four controlled clinical studies.

PURPOSE: To determine the effects of the herbal fixed-dose combination PRO 160/120 (extracts from saw palmetto fruits and stinging nettle roots) on nocturnal voiding frequency, as measured by question 7 of the IPSS questionnaire, in patients with moderate-to-severe LUTS/BPH after 24 weeks of treatment compared to placebo, to the α-blocker tamsulosin, or to the 5α-reductase inhibitor finasteride. METHODS: The study is about post hoc evaluation of four published randomized, double-blind clinical trials on PRO 160/120, two compared with placebo, one with finasteride and one with tamsulosin. In addition, a pooled data analysis of the two placebo-controlled trials was conducted. RESULTS: We analyzed data from a total of 922 patients with a mean age of 66 years and a mean baseline nocturnal voiding frequency of 2.1. In the pooled analysis of placebo-controlled trials, nocturnal voids improved by 0.8 (29 %) with PRO 160/120 compared to 0.6 (18 %) with placebo (p = 0.015, Wilcoxon test, one-tailed). The 69 % responder rate to PRO 160/120 was significantly superior to the placebo response (52 %; p = 0.003, χ (2)-test, two-tailed). The majority of responders improved by 1 void/night. Absolute improvements and response rates were consistently higher with PRO 160/120 than with placebo over a range of baseline nocturnal voiding frequencies. There were no differences between PRO 160/120 and finasteride or tamsulosin regarding absolute improvement of nocturnal voids or responds rates. CONCLUSION: PRO 160/120 significantly improved nocturnal voiding frequency compared to placebo and similar to tamsulosin or finasteride.

Nocturia and sleep quality after transurethral resection of the prostate.

OBJECTIVES: To evaluate the clinical efficacy of transurethral resection of the prostate on nocturia and sleep disorders in patients with lower urinary tract symptoms suggestive of benign prostatic obstruction. METHODS: A prospective multicenter study including lower urinary tract symptoms suggestive of benign prostatic obstruction patients with nocturia (twice or more) undergoing transurethral resection of the prostate was carried out. All patients were assessed using the International Prostate Symptom Score and the Pittsburgh Sleep Quality Index at baseline, and 6 months after transurethral resection of the prostate. RESULTS: Overall, 49 patients were included in the study. A total of 20 of them (41%) had a sleep disorder defined as a score of 5.5 or more on the Pittsburgh Sleep Quality Index global score. The nocturia score significantly correlated with component 4 of the Pittsburgh Sleep Quality Index (habitual sleep efficiency). Nocturia significantly decreased after transurethral resection of the prostate from 3.0 ± 1.2 to 1.9 ± 0.8, whereas the global Pittsburgh Sleep Quality Index score did not. In 20 patients with a sleep disorder before transurethral resection of the prostate, subjective sleep quality (component 1) and habitual sleep efficiency (component 4) significantly decreased after transurethral resection of the prostate, but this was not the case for the global Pittsburgh Sleep Quality Index score. In 16 patients with a persistent sleep disorder after transurethral resection of the prostate, International Prostate Symptom Score, voiding and storage symptoms score were higher than those of patients without a sleep disorder, although the nocturia score improved equivalently in both groups. CONCLUSIONS: Transurethral resection of the prostate diminishes nocturnal urinary frequency and partly improves sleep quality in patients with nocturia and lower urinary tract symptoms suggestive of benign prostatic obstruction. A persistent sleep disorder after transurethral resection of the prostate is associated with persistent voiding and storage symptoms.

Influence of smoking, coffee, and tea consumption on bladder pain syndrome in female twins.

OBJECTIVES: To assess the influence of smoking, coffee and tea consumption on the risk for bladder pain syndrome (BPS) using the O'Leary Interstitial Cystitis Symptom Index (ICSI). METHODS: In 2005, all twins born between 1959 and 1985 in Sweden (n = 42,852) were invited to participate in a web-based survey to screen for complex diseases, including BPS. Analyses were limited to female twins with information regarding bladder pain symptoms (n = 9349). Women with an ICSI score ≥6 with required nocturia and bladder pain were defined as having BPS symptoms. Logistic regression was used to estimate odds ratios (ORs) with 95% confidence intervals (CIs). Environmental and genetic influences were assessed in co-twin control analysis. RESULTS: Tea consumption was associated with an increased risk for BPS (OR 1.26, 95% CI 1.02-1.55 for low tea consumption; OR 1.74, 95% CI 1.24-2.44 for high tea consumption). Coffee consumption was not a risk factor for BPS (OR 1.1, 95% CI .84-1.45). Former and current smoking was associated with a higher risk of BPS (OR 1.5, 95% CI 1.18-1.89; and OR 1.49, 95% CI 1.16-1.92, respectively), but results from co-twin control analysis suggested that the association between smoking and BPS was confounded by familial factors. CONCLUSIONS: Tea and smoking are environmental risk factors for BPS, which are amenable to intervention. The effects of smoking on the risk for BPS may, however, be confounded by familial factors.