deamino-arginine-vasopressin and Nocturia

Patients with benign prostatic hyperplasia (BPH) receive α-blockers as first-line therapy to treat lower urinary tract symptoms; however, some individuals still experience residual storage symptoms. Antimuscarinics, β3-agonists, and desmopressin are effective add-on medications. Nevertheless, there is currently no evidence for the appropriate choice of the first add-on medication. This systematic review aimed to investigate the clinical benefits of antimuscarinics, β3-agonists, and desmopressin, in addition to α-blockers, for persistent storage symptoms in BPH patients.. A comprehensive literature search of randomized controlled trials (RCTs) comparing the efficacy of different add-on medications in BPH patients with persistent storage symptoms despite α-blocker treatment was conducted. Clinical outcomes included the International Prostate Symptom Score (IPSS), IPSS storage subscore, nocturia, micturition, and urgency. A network meta-analysis was performed to estimate the effect size. Surface under cumulative ranking curves (SUCRAs) were used to rank the included treatments for each outcome.. A total of 15 RCTs were identified. Add-on imidafenacin and mirabegron resulted in significant improvement in all outcomes assessed. Other add-on medications such as desmopressin, tolterodine, solifenacin, fesoterodine, and propiverine showed positive benefits for most, but not all, outcomes. Based on the SUCRA rankings, add-on desmopressin was the best-ranked treatment for IPSS and nocturia, and add-on imidafenacin was the best for the IPSS storage subscore and micturition.. BPH patients presenting with persistent storage symptoms despite α-blocker administration are recommended to include additional treatment. Desmopressin and imidafenacin may be considered high-priority add-on treatments because of their superior efficacy compared with other medications.

Topics: Adrenergic alpha-Antagonists; Deamino Arginine Vasopressin; Drug Therapy, Combination; Humans; Lower Urinary Tract Symptoms; Male; Muscarinic Antagonists; Network Meta-Analysis; Nocturia; Prostatic Hyperplasia; Treatment Outcome

Desmopressin acetate was recommended for nocturia in benign prostatic hyperplasia (BPH) patients recently, but its effect and safety is still controversial. We aimed to establish a systematic review and meta-analysis to confirm its effect on symptom relief and adverse effects.. A systematic search was performed in PubMed, Cochrane Library, EMBASE, Medline, Web of Science and Science Direct databases from January 2000 to October 2021 for controlled trials of BPH patients comparing oral desmopressin with control groups. The mean difference (MD) and odds ratio (OR) were meta-analyzed.. Four articles with 500 patients were included. Significantly greater benefit was detected for the desmopressin group in the improvement of nocturia (P = .004), international prostate symptom score - storage (IPSS-S) (P = .03), and quality of life (QoL) (P = .04) scores. Patients treated with desmopressin were at higher risk than the control group for short-term adverse events (P < .001), including nausea (4.71%, P = .04), headache (20%, P < .00001), dizziness (5.88%, P = .02) and hyponatremia (4.71%, P = .04), but the long-term incidence might decrease.. Desmopressin acetate can reduce nocturia frequency and improve the IPSS-S and QoL score in BPH patients. Some adverse reactions of desmopressin, such as hyponatremia, headache, dizziness and nausea, may be mild and short-term. No significant difference of desmopressin was found in improving the overall IPSS score and maximum urine flow.

Topics: Deamino Arginine Vasopressin; Dizziness; Headache; Humans; Hyponatremia; Male; Nausea; Nocturia; Prostatic Hyperplasia; Quality of Life; Treatment Outcome

Nocturia is the most bothersome of lower urinary tract symptoms in men. Desmopressin, a synthetic analog of the human hormone vasopressin, has been used for the treatment of nocturia. However, the guidelines include varying recommendations for the use of desmopressin for the management of nocturia in men. Therefore, the Korean Urological Association (KUA) developed recommendations for desmopressin for the treatment of nocturia in men.. A rigorous systematic review was performed and Grading of Recommendations, Assessment, Development, and Evaluation methodology was used to rate the certainty of evidence for patient outcomes and to develop the evidence into recommendations. The steering group, guidelines development group, systematic review team, and external review group consisted of members of the Korean Continence Society, Korean Society of Geriatric Urological Care, and KUA, respectively, who were involved in the guidelines development process.. The guidelines address the benefits, harms, patients' values and preferences, costs, and resources related to desmopressin by using a single clinical question: What is the effectiveness of desmopressin compared to that of placebo, behavior modification, or other pharmacological therapies?. The guidelines development panel suggests desmopressin for men with nocturia instead of placebo, behavior modification, or alpha-blocker monotherapy (low certainty of evidence, weak recommendation). Additionally, the panel suggests desmopressin combination therapy with alpha-blockers for men with nocturia instead of alpha-blocker monotherapy or alpha-blocker combination therapy with anticholinergic agents (low certainty of evidence, weak recommendation).

Topics: Adrenergic alpha-Antagonists; Aged; Deamino Arginine Vasopressin; Humans; Lower Urinary Tract Symptoms; Male; Nocturia; Republic of Korea; Treatment Outcome

Nocturia is a prevalent symptom with varied aetiology and no consensus on treatment options.. We systematically reviewed evidence comparing the benefits and harms of various treatment options for nocturia or nocturnal incontinence in women.. Literature search was performed using Embase, Medline, and Cochrane databases (from 1 January 1946 to 26 September 2017), following the methods detailed in the Cochrane Handbook. The protocol was registered with PROSPERO. Certainty of evidence was assessed with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach.. The literature search identified 3573 citations, of which 11 full-text articles were included. Three studies on desmopressin and four on antimuscarinics provided evidence of improving nocturia symptoms. Four studies on behavioural treatment provided limited evidence and controversial results. One study on oestrogen did not prove the benefit of any mode of administration, and one small study on functional magnetic stimulation provided some evidence of effectiveness in nocturia. One randomised controlled trial (RCT; 141 participants) reported a statistically significant difference between the desmopressin and placebo groups (desmopressin patients experienced 0.75 [95% confidence interval {CI} 0.47-1.03] nocturia episodes less than those experience by the placebo group; certainty of evidence = low). The only RCT on antimuscarinics in women with nocturia reported that oxybutynin reduced the number of nocturia episodes by 0.3 (95% CI -0.02 to 0.62) versus placebo. In one RCT comparing tolterodine with the combination of tolterodine with behavioural therapy, there was significant change from baseline nocturnal incontinence episodes in both groups.. There is some evidence that desmopressin and antimuscarinics are effective treatment options for nocturia; however, there is very limited evidence for other treatment options. The findings should be interpreted with caution as there were some methodological flaws in the included studies, particularly outcome heterogeneity.. This review identified several medical treatments for nocturia in women, such as desmopressin and antimuscarinics, which appear to improve the severity of the condition.

Topics: Adult; Deamino Arginine Vasopressin; Female; Humans; Middle Aged; Muscarinic Antagonists; Nocturia; Randomized Controlled Trials as Topic; Tolterodine Tartrate

Topics: Administration, Sublingual; Adult; Age Factors; Aged; Antidiuretic Agents; Deamino Arginine Vasopressin; Dose-Response Relationship, Drug; Drug Monitoring; Female; Humans; Male; Middle Aged; Nocturia; Polyuria; Tablets

Nocturia is defined as awakening due to the desire to void during a period of intended sleep. The pathophysiology of nocturia is multifactorial and management remains a challenge. Herein, we provide an overview of the management strategies for nocturia and summarize the existing evidence for treatment of nocturia across the condition's broad etiologic categories: nocturnal polyuria, diminished bladder capacity, and global polyuria.. Treatment should begin with behavioral modification. A high level of evidence supports the efficacy of desmopressin in the treatment of nocturnal polyuria. Data supporting the efficacy of α-blockers, antimuscarinics, and surgical bladder outlet procedures in the treatment of nocturia remains limited. Treatment options for nocturia are determined by underlying mechanism. Desmopressin is effective in treating nocturnal polyuria. Surgical intervention, α-blockers, and antimuscarinics may improve nocturia when associated with lower urinary tract symptoms or overactive bladder in the setting of diminished bladder capacity.

Topics: Adrenergic alpha-Antagonists; Antidiuretic Agents; Behavior Therapy; Deamino Arginine Vasopressin; Humans; Lower Urinary Tract Symptoms; Muscarinic Antagonists; Nocturia; Organ Size; Polyuria; Urinary Bladder; Urinary Bladder, Overactive

To systematically assess all available evidence on efficacy and safety of desmopressin for treating nocturia in patients with multiple sclerosis (MS).. This systematic review was performed according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Studies were identified by electronic search of Cochrane register, Embase, Medline, Scopus (last search March 3, 2018) and by screening of reference lists and reviews.. After screening of 7015 abstracts, 8 prospective, and 1 retrospective studies were included enrolling a total of 178 patients. The mean patient age ranged between 43 and 51 years. A significant decrease in the number of micturitions per night was reported in 5 studies. An increase in the maximum hours of uninterrupted sleep was only found in two studies. A significant reduction of the volume of nocturnal incontinence was described in one study. The patient satisfaction rates ranged from 56% to 82%. The rate of adverse events was between 0% and 57.9%. The rate of hyponatremia ranged from 0% to 23.5% and other commonly reported adverse events were headache, nausea, fluid retention, rhinitis/epistaxis, malaise, and swollen ankles. Risk of bias and confounding was relevant in all studies.. Preliminary data suggest that desmopressin might be effective for treating nocturia in patients with MS. However, adverse events are relatively common, the overall quality of evidence is low and the number of studied patients is very limited. Further studies with newer formulations of desmopressin are highly warranted.

Topics: Antidiuretic Agents; Deamino Arginine Vasopressin; Humans; Multiple Sclerosis; Nocturia; Treatment Outcome

To evaluate the efficacy and safety of desmopressin treatment in women with nocturia.. The PubMed, EMBASE, ISI web of knowledge, and the Cochrane Controlled Trial Register of Controlled Trials were searched from their inception date till April, 2019. The meta-analysis was performed by Revman 5.3. This review also stratified each outcome by dose (< 25 μg, 25 μg versus > 25 μg) to explore the differences in the dose response for orally disintegrating tablet (ODT).. Seven publications with seven trials were included in this review. The methodological quality of these trials was fair, and four studies had low risk of bias. The number of nocturnal voids per night was significantly decreased by desmopressin when compared to the control [6 trials, Weighted Mean Difference (WMD) = 0.41, P < 0.00001], and the difference between < 25, 25 and > 25 μg dose ODT groups was also significant (P = 0.03). The duration of first sleep period was significantly increased by desmopressin [4 trials, WMD = 66.64, P < 0.00001], and the difference between these three doses ODT was not significant (P = 0.15). Overall, the risk ratios (RR) for 33% responder rate showed significance when compared with desmopressin to controls [3 trials, RR = 1.30, P = 0.0003]. The number of total adverse events was similar in both desmopressin and control groups [5 trials, RR = 0.95, P = 0.59], otherwise, showed no significant difference between different ODT dose groups (P = 0.82).. Desmopressin had certain efficacy and adequate safety in women with nocturia. The exploration of appropriate dose for female patients, and other influential factors, such as age should be conducted and considered in future.

Topics: Antidiuretic Agents; Deamino Arginine Vasopressin; Female; Humans; Nocturia; Randomized Controlled Trials as Topic; Treatment Outcome

Nocturia is a common urinary condition experienced by both men and women. While desmopressin has historically been utilized to treat conditions such as central diabetes insipidus and primary nocturnal enuresis, there is an increased interest in the use of desmopressin in the management of adult nocturia. Areas covered: This article provides a review on the pathophysiology of nocturia and the clinical outcomes and safety profile of desmopressin in the management of adult nocturnal voiding dysfunction. Expert opinion: To date, desmopressin is the only anti-diuretic hormone that is approved for nocturia. Published literature on desmopressin demonstrate good clinical efficacy in terms of number of nocturnal voids, voided volume and sleep period. Newer formulations have shown that a minimum dosage of 25 μg orally disintegrating sublingual desmopressin appears to be ideal for women, whereas men usually benefit from a minimum of 50 μg. Of the known adverse drug reactions, hyponatremia remains a major concern especially in patients over 65 years of age. At present, long term data on desmopressin remains scarce. Lastly, it is important to stress that no single treatment deals with nocturia in all contexts, and careful assessment remains essential to identify the appropriate and safest treatment in each patient.

Topics: Antidiuretic Agents; Aquaporins; Clinical Trials as Topic; Deamino Arginine Vasopressin; Government Regulation; Humans; Hyponatremia; Nocturia; Treatment Outcome

To assess the effects of desmopressin as compared to other interventions in the treatment of nocturia in men.. We performed a comprehensive search using multiple databases and abstract proceedings with no restrictions on the language of publication or publication status, up until August 2017. We included randomised or quasi-randomised trials. Inclusion criteria were men with nocturia defined as one or more voids per night. Two review authors independently examined full-text reports, identified relevant studies, assessed the eligibility of studies for inclusion, extracted data, and assessed risk of bias. We performed statistical analyses using a random-effects model and assessed the quality of the evidence (QoE) according to Grades of Recommendation, Assessment, Development and Evaluation (GRADE).. We included 14 studies with 2 966 randomised men across five comparisons (we did not include one comparison [desmopressin vs behaviour modification] in the abstract due to a lack of data with regard to primary outcomes). Desmopressin vs placebo: based on short-term follow-up (≤3 months), desmopressin may have a similar effect on the number of nocturnal voids (mean difference [MD] -0.46, 95% confidence interval [CI] -0.94 to 0.01; low QoE). We are uncertain about the effect of desmopressin on major adverse events (risk ratio [RR] 0.97, 95% CI: 0.10-9.03; very low QoE). For intermediate-term follow-up (3-12 months), desmopressin may reduce the number of nocturnal voids in an appreciable number of men (MD -0.85, 95% CI: -1.17 to -0.53; low QoE). Desmopressin may result in little or no difference in major adverse events (RR 3.05, 95% CI: 0.13-73.39; low QoE). We found no evidence on quality of life. Desmopressin vs α-blocker (AB): based on short-term follow-up, desmopressin likely has a similar effect on the number of nocturnal voids (MD 0.30, 95% CI: -0.20 to 0.80; moderate QoE) and quality of life (MD 0.00, 95% CI: -0.35 to 0.35; moderate QoE). There were no major adverse events in either study group. Desmopressin plus AB vs AB alone: based on short-term follow-up, combined therapy likely results in a small, unimportant reduction in the number of nocturnal voids (MD -0.47, 95% CI: -0.73 to -0.21; moderate QoE) and quality of life (MD -0.29, 95% CI: -0.51 to -0.07; moderate QoE). The risk of major adverse events may be similar (RR 0.30, 95% CI: 0.01-7.32; low QoE). Desmopressin plus AB vs AB plus an anticholinergic: based on short-term follow-up, combined therapy likely results in little or no difference in the number of nocturnal voids (MD -0.43, 95% CI: -0.97 to 0.11; moderate QoE). We found no evidence on quality of life. There were no major adverse events in either study group.. Desmopressin may reduce the number of nocturnal voids compared to placebo up to 12 months of follow-up without increase in major adverse events. The effect on the number of nocturnal voids is likely similar to that of ABs with very infrequent major adverse events. There appears to be no added benefit in the combined use of an AB or an anticholinergic with desmopressin.

Topics: Adrenergic alpha-Antagonists; Deamino Arginine Vasopressin; Humans; Male; Nocturia; Quality of Life; Randomized Controlled Trials as Topic; Treatment Outcome

Topics: Antidiuretic Agents; Deamino Arginine Vasopressin; Dose-Response Relationship, Drug; Humans; Male; Nocturia; Treatment Outcome

Topics: Deamino Arginine Vasopressin; Double-Blind Method; Humans; Male; Nocturia; Polyuria; Urinary Bladder

To raise awareness on nocturia disease burden and to provide simplified aetiologic evaluation and related treatment pathways.. A multidisciplinary group of nocturia experts developed practical advice and recommendations based on the best available evidence supplemented by their own experiences.. Nocturia is defined as the need to void ≥1 time during the sleeping period of the night. Clinically relevant nocturia (≥2 voids per night) affects 2%-18% of those aged 20-40 years, rising to 28%-62% for those aged 70-80 years. Consequences include the following: lowered quality of life; falls and fractures; reduced work productivity; depression; and increased mortality. Nocturia-related hip fractures alone cost approximately €1 billion in the EU and $1.5 billion in the USA in 2014. The pathophysiology of nocturia is multifactorial and typically related to polyuria (either global or nocturnal), reduced bladder capacity or increased fluid intake. Accurate assessment is predicated on frequency-volume charts combined with a detailed patient history, medicine review and physical examination. Optimal treatment should focus on the underlying cause(s), with lifestyle modifications (eg, reducing evening fluid intake) being the first intervention. For patients with sustained bother, medical therapies should be introduced; low-dose, gender-specific desmopressin has proven effective in nocturia due to idiopathic nocturnal polyuria. The timing of diuretics is an important consideration, and they should be taken mid-late afternoon, dependent on the specific serum half-life. Patients not responding to these basic treatments should be referred for specialist management.. The cause(s) of nocturia should be first evaluated in all patients. Afterwards, the underlying pathophysiology should be treated specifically, alone with lifestyle interventions or in combination with drugs or (prostate) surgery.

Topics: Antidiuretic Agents; Deamino Arginine Vasopressin; Humans; Life Style; Nocturia; Polyuria; Quality of Life

Topics: Adult; Aged; Antidiuretic Agents; Deamino Arginine Vasopressin; Humans; Hyponatremia; Incidence; Middle Aged; Nasal Sprays; Nocturia; Off-Label Use

Nocturia is the bothersome symptom of awakening one or more times per night to void. Desmopressin is a commonly used medication for treating nocturia.. To assess the effects of desmopressin as compared to other interventions in the treatment of nocturia in men.. We performed a comprehensive search of medical literature with no restrictions on the language of publication or publication status. The date of the latest search of all databases was August 2017.. We included randomized or quasi-randomized trials. Inclusion criteria were men with nocturia defined as one or more voids per night. Trials of children, adults with primary or secondary enuresis or underlying distinct disorders were excluded.. Two review authors independently classified studies and abstracted data from the included studies. We performed statistical analyses using a random-effects model and interpreted data according to the Cochrane Handbook for Systematic Reviews of Interventions.. We included 14 studies with 2966 randomized men across five comparisons. Desmopressin versus placebo: based on short-term follow-up (up to three months), desmopressin may have a similar effect on the number of nocturnal voids (mean difference (MD) -0.46, 95% confidence interval (CI) -0.94 to 0.01; low-quality evidence). We are uncertain about the effect of desmopressin on major adverse events at short-term follow-up (risk ratio (RR) 0.97, 95% CI 0.10 to 9.03; very low-quality evidence). For intermediate-term follow-up (three to 12 months), desmopressin may reduce the number of nocturnal voids in an appreciable number of participants (MD -0.85, 95% CI -1.17 to -0.53; low-quality evidence). Desmopressin may result in little or no difference in major adverse events at intermediate-term follow-up (RR 3.05, 95% CI 0.13 to 73.39; low-quality evidence). We found no evidence on quality of life. Subgroup analyses suggest a larger effect with oral, higher-dose formulations of desmopressin and in men with documented nocturnal polyuria. Desmopressin versus behavior modification: there were no data regarding the effect on the number of nocturnal voids, quality of life, or major adverse events. Desmopressin versus alpha-blocker: based on short-term follow-up, desmopressin likely has a similar effect on the number of nocturnal voids (MD 0.30, 95% CI -0.20 to 0.80; moderate-quality evidence) and quality of life (MD 0.00, 95% CI -0.35 to 0.35; moderate-quality evidence). There were no major adverse events in either study group. Desmopressin plus alpha-blocker versus alpha-blocker alone: based on short-term follow-up, combination therapy likely results in a small, unimportant reduction in the number of nocturnal voids (MD -0.47, 95% CI -0.73 to -0.21; moderate-quality evidence) and quality of life (MD -0.29, 95% CI -0.51 to -0.07; moderate-quality evidence). The risk of major adverse events may be similar (RR 0.30, 95% CI 0.01 to 7.32; low-quality evidence). Desmopressin plus alpha-blocker versus alpha-blocker plus an anticholinergic: based on short-term follow-up, combination therapy likely results in little or no difference in the number of nocturnal voids (MD -0.43, 95% CI -0.97 to 0.11; moderate-quality evidence). We found no evidence on quality of life. There were no major adverse events in either study group.. Desmopressin may reduce the number of nocturnal voids in an appreciable number of participants compared to placebo in intermediate-term (three to 12 months) follow-up without increase in major adverse events. We found no evidence to compare its effects to behavior modification. The effect on the number of nocturnal voids is likely similar to that of alpha-blockers short-term with very infrequent major adverse events. There appears to be no added benefit in the combined use of desmopressin with an alpha-blocker or an anticholinergic. The findings of this review were limited by short-term follow-up, study limitations, and imprecision.

Topics: Adrenergic alpha-Antagonists; Aged; Antidiuretic Agents; Cholinergic Antagonists; Deamino Arginine Vasopressin; Drug Therapy, Combination; Humans; Male; Middle Aged; Nocturia; Quality of Life; Randomized Controlled Trials as Topic; Withholding Treatment

Describe current shortcomings in clinical research on the treatment of nocturia in adults, and suggest new directions for future studies in this field.. A literature search was conducted using the keywords 'nocturia,' 'nocturnal polyuria,' 'sleep,' and 'hypertension.'. Nocturia, or waking up at night to void, is a highly prevalent and bothersome lower urinary tract symptom (LUTS) affecting up to 40% of adults. Since the majority of patients are diagnosed with nocturnal polyuria (NP) as one of the underlying causes, it is not surprising that the effect of treatments for overactive bladder (OAB) and bladder outlet obstruction (BOO) are disappointing with regard to nocturia. Therefore, we suggest to conduct studies in which nocturic patients are treated according to the underlying pathophysiology: (1) antimuscarinics or β3-agonists for OAB symptoms, (2) α-blockers or 5α-reductase inhibitors in men with BOO caused by enlarged prostates, (3) desmopressin or diuretics for NP, (4) continuous positive airway pressure in nocturic patients with obstructive sleep apnea, and (5) all its combinations in case of combined pathophysiology. Not only the effect on treatment efficacy or side effects needs to be assessed, but also the impact on related comorbidities such as sleep disorders, hypertension, and endocrine functions such as blood glucose regulation.. Future research needs to subtype nocturic patients in order to adapt treatment according to the underlying cause.

Topics: Antidiuretic Agents; Clinical Protocols; Deamino Arginine Vasopressin; Diuretics; Humans; Hypertension; Interdisciplinary Communication; Nocturia; Sleep Deprivation

Nocturia is a significantly underestimated disorder, resulting in general worsening of patients' quality of life, while morbidity and mortality are increasing. Several urologic and other pathologic causes can be described in the background including relatively severe conditions. Therefore, accurate evaluation and adequate treatment is recommended. In this review the authors summarize the international literature regarding nocturia. PubMed and ScienceDirect databases were accurately reviewed for the relevant information. Epidemiology, etiology, unfavourable effects, diagnosis and possible treatment options were analysed. They found that symptoms can be releaved by lifestyle changes and traditional therapy in several cases, but clinically significant improvement can be reached using desmopressin in patients suffering from nocturnal polyuria. The authors conclude that nocturia may have negative effects on patients' quality of life and also on the society. Early detection and proper treatment is essential. Orv. Hetil., 2016, 157(36), 1419-1426.

Topics: Deamino Arginine Vasopressin; Female; Humans; Male; Nocturia; Polyuria; Urinary Bladder, Overactive

We systematically reviewed desmopressin as treatment for nocturia in generally healthy adults with a focus on benefits and harms.. After a literature search we identified 10 articles (2,191 patients) that met our inclusion criteria of parallel group design, randomized, controlled trials with information on at least 1 benefit or harm of desmopressin in patients with nocturia. We evaluated the quality of included trials based on The Cochrane Collaboration criteria, assessed heterogeneity using the I(2) statistic and performed random effects meta-analysis.. Studies were generally of high quality, although 4 used an active run-in period to titrate the dose and exclude patients with adverse effects or who were nonresponders. Thus, they were at high risk for bias. Desmopressin doses of at least 25 mcg or greater decreased nocturnal voids and increased time to first void. A dose of 100 mcg provided just more than an hour of additional sleep before the first void compared with placebo as well as 0.72 fewer voids per night. Higher doses provided no significant increase in benefit. Hyponatremia (RR 5.1) and headache (RR 4.3) were the most common adverse effects. Serious adverse effects were rare.. Desmopressin appears to offer a modest benefit for treating nocturia in generally healthy adults with adequate safety. The initial dose should be between 50 and 100 mcg. Higher doses should only be used with caution and a lower initial dose of 25 to 50 mcg is appropriate in elderly patients. All patients should be monitored for hyponatremia. The drug should be used with caution in patients with chronic lung disease due to the rare occurrence of respiratory failure. Additional well designed, adequately powered studies 1 or more years in duration are needed.

Topics: Adult; Antidiuretic Agents; Deamino Arginine Vasopressin; Humans; Nocturia; Treatment Outcome

Topics: Antidiuretic Agents; Clinical Trials, Phase III as Topic; Deamino Arginine Vasopressin; Dose-Response Relationship, Drug; Humans; Nocturia; Randomized Controlled Trials as Topic; Receptors, Vasopressin; Tablets; Urea; Urination

Nocturia is a bothersome urologic symptom and is defined as awakening from sleep once or more times to void. The condition is highly prevalent in men and women and increases in prevalence with age. Impact on quality of life is substantial as is the associated morbidity and mortality.. A PubMed literature search was undertaken to identify evidence for the currently available and utilized pharmacotherapy options for the treatment of nocturia. Available pharmacologic treatments include desmopressin, α-blockers, antimuscarinics, and other less commonly utilized therapies. Desmopressin is generally found to have high-level evidence to support its use for the indication of nocturnal polyuria, a form of nocturia caused by excessive nighttime urine production. α-blockers and antimuscarinics are generally recommended in the setting of benign prostatic hypertrophy in men and overactive bladder in both men and women.. Clinical trials addressing nocturia often report statistically significant results that do not translate to clinically significant reductions in nighttime voids. As a result, the clinical utility of these agents has been called into question. Further drug development and clinical trials specifically focused on nocturia are needed. Furthermore, improved patient-focused assessment tools to measure the impact on symptom reduction, improvement in sleep quality, and improvement in quality of life are important in understanding what matters most to patients and what outcomes translate to patient satisfaction with care.

Topics: Adrenergic alpha-Antagonists; Age Factors; Antidiuretic Agents; Deamino Arginine Vasopressin; Humans; Muscarinic Antagonists; Nocturia; Prevalence; Quality of Life; Sleep Wake Disorders; Urination Disorders

Nocturia--waking up during the night due to the urge to urinate and empty the bladder--is a serious problem for affected patients. In the past decades, nocturia has been primarily regarded as an irritative symptom of benign prostate hyperplasia (BPH). This symptom is however frequently not influenced by different BPH treatments. In the last couple of years one has come to the conclusion that the prostate is less involved and in part responsible for the symptoms since women are also frequently affected. For these reasons nocturia is looked at differently. It is a highly prevalent symptom which neither qualitatively nor quantitative differs between men and women. Many factors lead to nocturia. The following diseases are involved: coronary heart disease, diabetes mellitus or insipidus, lower urinary tract symptoms (LUTS), states of anxiety or insomnia as well as behavioural and environmental factors. Nocturia can be categorised in nocturnal polyuria (overproduction of nightly urine) or a diminished bladder capacity or a combination of both. These entities can be easily differentiated by arithmetic analysis, e.g., a 48-hour voiding diary. Only recently nocturia has been classified according to the aetiology and pathogenesis, making a differentiated treatment possible. However, even in the cases in which the underlying cause cannot be found behavioural changes can help. Nevertheless, pharmacological treatments are inevitable. Medical treatments include: desmopressin, anticholinergics and antimuscarinics, general-medical measures like support stockings, different time for the intake of diuretics or in specific cases the nasal CPAP artificial respiration (continuous positive airway pressure). In spite of the partly high effectiveness of these measures, treatment should be customised taking possible side effects in account.

Topics: Deamino Arginine Vasopressin; Diagnosis, Differential; Female; Humans; Male; Nocturia; Polyuria; Prostatic Hyperplasia; Urodynamics

To explore the durability of efficacy and gender differences during chronic administration of desmopressin in nocturia.. This pooled analysis of three short-term efficacy studies, with extensions, of desmopressin administered as orally disintegrating tablet (ODT) or solid tablet in nocturia treatment, comprised 351 patients completing 40-56 weeks' treatment. Efficacy endpoints of change in number of nocturnal voids and duration of initial undisturbed sleep period from baseline were analyzed to determine response durability and gender differences.. The mean decrease in number of nocturnal voids during short-term treatment was maintained and further reduced during the long term. At 52 weeks, the mean decrease in number of nocturnal voids from baseline reached 1.4-2.1 voids for desmopressin ODT 25-100 µg. Following 40-week tablet treatment, the decrease in number of nocturnal voids was 0.8-1.5 for desmopressin 100-400 µg. The mean decrease in nocturnal voids (25-50 µg ODT) was greater for females than males. For females, the improvement in initial period of undisturbed sleep was 2.5-3 hr for desmopressin ODT 25-100 µg, compared with 1.3-2.6 hr for males. No gender difference in efficacy was seen in the tablet studies.. The decrease in nocturnal voids and improvement in sleep with short-term desmopressin treatment were maintained throughout long-term treatment. A durable gender difference in efficacy in favor of females was observed with desmopressin ODT 25 µg. Further, large-scale long-term trials are needed to confirm the durability of efficacy with gender-specific doses of desmopressin.

Topics: Adolescent; Child; Child, Preschool; Clinical Trials, Phase III as Topic; Deamino Arginine Vasopressin; Dose-Response Relationship, Drug; Double-Blind Method; Endpoint Determination; Female; Humans; Long-Term Care; Male; Medical Records; Nocturia; Randomized Controlled Trials as Topic; Renal Agents; Sex Factors; Surveys and Questionnaires; Tablets; Treatment Outcome

The purpose of this analysis was to evaluate the efficacy and safety of desmopressin for the treatment of nocturia.. Databases including MEDLINE, EMBASE, ISI web of knowledge, the Cochrane Controlled Trial Register of Controlled Trials and Chinese Biological Medical Database were searched to identify randomized controlled trials (RCTs) that referred to the efficacy and safety of desmopressin for the treatment of nocturia. A systematic review and meta-analysis were conducted.. Five studies involving 619 participants were included for the meta-analysis, and 8 RCTs of cross-over design were also identified for the systematic review. The analysis revealed that desmopressin might significantly decrease the frequency of nocturnal voids, nocturnal urine volume and nocturnal diuresis, potentially resulting in an extended duration of the first sleep period and improved sleep quality. The adverse effects of desmopressin were similar to those observed in the placebo group.. Administered desmopressin was an effective and well-tolerated treatment for nocturia.

Topics: Antidiuretic Agents; Deamino Arginine Vasopressin; Humans; Nocturia; Treatment Outcome; Urination

Nocturia is a bothersome and highly prevalent condition characterized by the need to wake to void at night. Nocturia is equally common in men and women, and although its prevalence increases with age, a significant proportion of younger people are also affected. Nocturia leads to fragmentation of sleep and consequently to a serious decline in daytime functioning and in quality of life and health. Its impact should not be underestimated by clinicians and therefore a review on nocturia is timely and relevant.. Traditionally, nocturia is regarded as a symptom of benign prostatic enlargement and/or overactive bladder syndrome, with treatment therefore directed toward increasing the capacity of the bladder to hold urine. Such treatments have proven ineffective in many patients because nocturnal polyuria, an overproduction of urine at night, has been found to be present in the majority of patients. Nocturia can be attributed to some underlying pathological factors but it can also be a distinct clinical entity with specific pathogenesis. Frequency-volume charts are recommended for routine use in clinical practice, to determine whether nocturia is a result of excessive urine production at night, or of small voided volumes due to bladder problems, or a combination of these factors. Desmopressin, a synthetic analogue of the antidiuretic hormone, should be considered in patients with nocturia where nocturnal polyuria is present.. Contrary to popular and medical misconception nocturia is an important condition leading to general morbidity and with serious impact on overall quality of life and health. We advise clinicians to pay attention to nocturia and diagnostics should be offered. Treatment modalities are available and have to be discussed with the patient.

Topics: Antidiuretic Agents; Deamino Arginine Vasopressin; Diuretics; Female; Humans; Male; Muscarinic Antagonists; Nocturia; Quality of Life; Sleep Deprivation

Nocturia is a bothersome and highly prevalent urological condition characterised by the need to wake to void at night. Contrary to popular misconception, nocturia is equally common in men and women, and although its prevalence increases with age, a significant proportion of younger people are also affected. Nocturia leads to repeated fragmentation of sleep and consequently to a serious decline in daytime functioning and in overall quality of life and health. As such, its impact should not be underestimated by clinicians. Traditionally, nocturia has been regarded as a symptom of benign prostatic enlargement and/or overactive bladder syndrome, with treatment therefore directed towards increasing the capacity of the bladder to hold urine. Such treatments have proven largely ineffective in many patients, likely because nocturnal polyuria (NP), a condition that results in overproduction of urine at night, has been found to be present in the majority of nocturia patients. As such, the traditional belief that nocturia is attributable to some other underlying pathological factors, is now being replaced by the acknowledgment that it can be a distinct clinical entity with specific pathogenesis. Frequency-volume charts are an invaluable tool, recommended for routine use in clinical practice, to determine whether nocturia is a result of excessive urine production at night, or of small voided volumes (indicating bladder storage problems), or indeed a combination of these factors. Given the specific antidiuretic action of desmopressin, a synthetic analogue of the body's own antidiuretic hormone, it should be considered as first-line therapy for patients with nocturia where NP is present.

Topics: Antidiuretic Agents; Deamino Arginine Vasopressin; Female; Humans; Male; Nocturia; Sex Factors; Sleep Wake Disorders; Urinary Bladder, Overactive

Nocturia is common in the elderly population and, aside from being a nuisance, it is associated with morbidity and mortality. Nocturia results from the complex interactions of several factors: changes in the urinary system and renal function with aging, the effects of sleep on renal function, changes in sleeping patterns associated with aging, and the presence of concurrent diseases and medications. Nocturia in the elderly can be caused by many conditions; a common cause is the syndrome of nocturnal polyuria. Although the pathophysiology of nocturnal polyuria remains obscure, some investigators believe that low night-time levels of antidiuretic hormone are involved. Proper management of nocturia requires identification of the specific underlying causes. This Review provides an overview of the mechanisms, evaluation and treatment of nocturia for the practicing nephrologist.

Topics: Aged; Aging; Antidiuretic Agents; Circadian Rhythm; Comorbidity; Deamino Arginine Vasopressin; Depression; Glomerular Filtration Rate; Humans; Kidney; Nocturia; Polyuria; Sleep; Sleep Apnea Syndromes; Sleep, REM; Syndrome; Urinary Bladder; Urination; Urodynamics

Desmopressin acetate is the synthetic analogue of the antidiuretic hormone arginine vasopressin. It has been employed clinically for >30 years in a range of formulations: intranasal solution (since 1972), injectable solution (since 1981), tablets (since 1987), and most recently, an oral lyophilisate (since 2005). The antidiuretic properties of desmopressin have led to its use in polyuric conditions including primary nocturnal enuresis, nocturia, and diabetes insipidus. While a large body of clinical data is available for desmopressin, and despite its widespread use, comprehensive reviews of the safety of desmopressin are lacking (although some case series have attempted to correlate patient and/or dosing characteristics with the occurrence of adverse reactions). The purpose of this paper is to review the safety of desmopressin, based on analyses of both published data (MedLine) and of adverse reactions reported to Ferring Pharmaceuticals, the major manufacturer of desmopressin. Based on the findings, suggested strategies to reduce the risk of adverse reactions are proposed. Treatment with intranasal and oral formulations of desmopressin is generally well tolerated, and side effects are usually minor. The risk of hyponatraemia, although small, can be reduced by adhering to the indications, dosing recommendations and precautions when prescribing desmopressin.

Topics: Adverse Drug Reaction Reporting Systems; Antidiuretic Agents; Clinical Trials as Topic; Deamino Arginine Vasopressin; Humans; Hyponatremia; Nocturia; Nocturnal Enuresis; Risk Factors

Nocturia may be attributable to nocturnal polyuria (nocturnal urine overproduction), a diminished nocturnal bladder capacity or a combination of the two conditions.A disorder of the vasopressin (antidiuretic hormone) system with very low or undetectable levels of vasopressin at night, affecting some elderly people, may cause an increase in the nocturnal urine output, which in the most extreme cases accounts for 85% of the 24-hour diuresis. The increased urine output can be treated with desmopressin orally at bedtime, generally using low doses. Self-imposed fluid restrictions before bedtime are not effective in reducing the nocturnal urine output in this condition. Nocturia is also more prevalent in association with a reduced bladder capacity. Antimuscarinic drugs are used in attempts to depress involuntary bladder contractions. Decreased nocturnal voided volumes in men and consequent increased nocturia may suggest difficulty in emptying the bladder or detrusor overactivity. alpha(1)-Adrenoceptor antagonists and 5alpha-reductase inhibitors are often used in men with symptoms indicative of benign prostatic hyperplasia, and one of their effects is reduction of nocturia. In women, estrogen deficiency, a common consequence of the menopausal transition, causes atrophic changes within the urogenital tract. Consequently, such women are more disposed to having urogenital symptoms, among them nocturia. This review emphasises the importance of correctly diagnosing and treating nocturia in elderly patients. This will improve patients' sleep and, in turn, reduce their risk of fall injuries and the associated detrimental consequences, thereby improving patients' health and quality of life.

Topics: Accidental Falls; Aged; Aged, 80 and over; Antidiuretic Agents; Deamino Arginine Vasopressin; Diuretics; Female; Humans; Male; Muscarinic Antagonists; Nocturia; Prevalence; Sleep Wake Disorders; Urinary Bladder; Urinary Bladder, Overactive

To investigate the long-term efficacy, quality of life (QoL), and safety of desmopressin orally disintegrating tablets (ODTs) in Japanese patients with nocturia.. 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).. 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.. 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.

Topics: Deamino Arginine Vasopressin; Female; Humans; Japan; Male; Middle Aged; Nocturia; Quality of Life; Surveys and Questionnaires; Time Factors; Treatment Outcome; Urological Agents

This study assessed the efficacy and safety of desmopressin orally disintegrating tablets (ODTs) in Japanese males (50 and 25 μg) and females (25 μg) with nocturia due to nocturnal polyuria (NP). Two Phase 3 randomized double-blind placebo-controlled studies of 342 males and 190 females with nocturia due to NP were conducted. The primary endpoint was change from baseline in mean number of nocturnal voids. In addition, time to first awakening to void, nocturnal urine volume, NP index (NPI), and quality of life were assessed during a 12-week treatment period. In males, 50 and 25 μg desmopressin ODTs significantly reduced the number of nocturnal voids by -1.21 (P < .0001) and - 0.96 (P = .0143), respectively, and significantly prolonged the time to first awakening to void by 117.60 minutes (P < .0001) and 93.37 minute (P = .0009), respectively, with no safety concerns. In females, 25 μg desmopressin ODT significantly prolonged the time to first awakening to void by 116.11 minutes (P = .0257), with no safety concerns. The reduction in the number of nocturnal voids (-1.11) was not significantly different compared with placebo (P = .0975). Desmopressin ODTs (50 and 25 μg) were an effective and well-tolerated treatment for nocturia due to NP in Japanese males, and desmopressin ODT 50 μg is an appropriate dose in these patients. For patients who are likely to experience hyponatremia, such as elderly males, starting with 25 μg desmopressin ODT should be considered.

Topics: Administration, Oral; Aged; Antidiuretic Agents; Deamino Arginine Vasopressin; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Japan; Male; Middle Aged; Nocturia; Polyuria; Tablets; Treatment Outcome

Clinical benefit has not been evaluated much in patients with nocturia.. To assess the clinical benefit of desmopressin orally disintegrating tablet (ODT) in women (25μg) and men (50μg) with nocturia due to nocturnal polyuria (NP).. Patients with NP from two randomised, placebo-controlled trials in men (CS41) and women (CS40) with two or more nocturnal voids per night were included.. Change from baseline in nocturnal voids, 33% and 50% responder status (average reduction of ≤33% and ≤50%, respectively, in the mean number of nocturnal voids vs baseline), and percentage of nights with at most one void or no voids (ie, complete response) during 3-mo treatment period were assessed for clinical benefit. Two-sided test (5% significance level) was used for all endpoints.. Demographics and baseline characteristics of patients in CS41 (N=230) and CS40 (N=232) were similar. A greater reduction in the mean number of nocturnal voids was seen with desmopressin ODT in men (treatment difference [TD]: -0.37 voids) compared with women (TD: -0.29 voids). For 33% and 50% responder status, TD with ODT versus placebo were 21% and 12%, respectively, in men, and 12% and 17%, respectively, in women. For the number of nights with at most one void, TDs were 11% and 13% (p<0.009 for both) for men and women, respectively. For complete response, TD was significant in men (TD: 9%, p<0.001). Limitations inherent in this analysis were evident as the data for cotreatments (baseline) and quality of life were not collected.. A stronger treatment effect with desmopressin ODT versus placebo and the magnitude of differences are indicative of clinical benefit in patients with NP.. We looked at the clinical benefit of desmopressin ODT in patients with nocturnal polyuria. We conclude that clinical benefit was observed with desmopressin ODT in these patients.

Topics: Administration, Oral; Aged; Deamino Arginine Vasopressin; Female; Humans; Male; Middle Aged; Nocturia; Polyuria; Tablets; Treatment Outcome

To compare the efficacy of desmopressin and placebo in independent geriatric outpatients with nocturnal polyuria (NP).. A prospective, randomized, single-center, national, double blind, placebo-controlled, fixed-dose, parallel group comparative trial was carried out. The study included 110 geriatric outpatients, 55 patients per treatment group using desmopressin acetate nasal spray (strength: 0.1 mg/ml) once daily of 10 μg/spray blast or placebo.. The NP positive geriatric outpatients with >33% nocturnal urine output volume, antidiuretic hormone (ADH) positive or negative were treated over 10 days with intranasal spray in the evening time (7 p.m.), drug or placebo. On day 1 voiding frequency, voiding volumes day and night, serum osmolarity and arginine-vasopressin (AVP) were measured at 7 p.m. On days 2, 5 and 10 creatinine, blood urea nitrogen (bun), blood count and C‑reactive protein (CrP), vena cava diameter and bioimpedance were measured and a structured interview was implemented (voiding frequency, sleeping behavior and subjective and cognitive behavior).. The NP patients showed a mean night voiding volume of 50.60%, 39.21% (n = 102) showed a low AVP level at baseline with no correlation to sodium concentration or voiding frequencies. The primary efficacy criterion, a decrease of the nocturnal voiding frequency during the course of the clinical trial as change from baseline at day 10 (visit 4) was 50% versus 41.40% in the verum versus placebo group, respectively but the differences were not significant. The U‑test showed superiority of AVP-positive NP patients to a positive reaction on desmopressin. Sleeping time hours increased in both groups without significant differences.. In this 10-day clinical trial desmopressin was not proven to be therapeutically superior to placebo with respect to micturition frequency or sleeping hours. Independent geriatric outpatients with decreased ADH levels seemed to respond and benefit from active treatment with desmopressin. The unexpected results in the placebo group may be due to the effect of intensive outpatient care and information on NP outpatients with normal AVP levels.

Topics: Aged; Deamino Arginine Vasopressin; Double-Blind Method; Female; Humans; Nocturia; Outpatients; Polyuria; Prospective Studies; Treatment Outcome

Evaluation of safety and efficacy of desmopressin/tolterodine combination therapy in women.. This double-blind, randomized, proof-of-concept study enrolled 106 patients (≥18 years), with overactive bladder (OAB) and nocturia, with ≥2 nocturnal voids, receiving a 3-month once-daily combination (desmopressin 25 µg, orally-disintegrating tablets [ODT]/tolterodine 4 mg [Detrol® LA]; n = 49) or monotherapy (tolterodine 4 mg/placebo ODT; n = 57). Primary endpoint was change from baseline in mean number of nocturnal voids. Secondary endpoints were change from baseline in nocturnal voided volume, time to first nocturnal void, and quality-of-life. Post-hoc exploratory analysis were performed for patients with and without baseline nocturnal polyuria (NP, n = 47 each).. Overall population showed a non-significant reduction in mean number of nocturnal voids with combination versus monotherapy (full analysis set: adjusted treatment contrast [TC], -0.34; P = 0.112). Change in mean nocturnal void volume (TC, -64.16 mL; P = 0.103), mean time to first nocturnal void (TC, 18.00 min; P = 0.385) and Nocturia Impact (NI) Diary. Low-dose desmopressin could be safely combined with tolterodine for treating nocturia in women with OAB, with a significant benefit in women with NP. Further, prospective validation studies of combination therapy are warranted in mixed NP/OAB population, based on this favorable proof-of-concept finding.

Topics: Adult; Aged; Antidiuretic Agents; Deamino Arginine Vasopressin; Double-Blind Method; Drug Combinations; Female; Humans; Middle Aged; Nocturia; Proof of Concept Study; Quality of Life; Time Factors; Tolterodine Tartrate; Urinary Bladder, Overactive; Urine; Urological Agents

SER120 desmopressin intranasal spray is the first U.S. Food and Drug Administration approved pharmacotherapy for nocturia. We evaluated its efficacy and safety in 2 randomized, double-blind, placebo controlled studies, DB3 and DB4.. A total of 1,333 intent to treat patients 50 years old or older with 2.16 or more nocturic voids per night during a 2-week screening period were randomized equally to SER120 intranasal spray 1.66 or 0.83 mcg, or placebo for a 12-week treatment. Co-primary end points were the mean change from baseline in nocturic episodes per night and the percent of patients with a 50% or greater reduction in mean nocturic episodes per night. Secondary end points were the validated INTU (Impact of Nighttime Urination) quality of life questionnaire in DB4, time to the first nocturic void and the percent of nights with 1 or fewer nocturic voids.. Each SER120 dose showed statistical significance vs placebo for the 2 co-primary end points, including the mean nocturic episodes per night (-1.4 with 0.83 mcg and -1.5 with 1.66 mcg vs -1.2 with placebo, each p <0.0001), the percent of patients with a 50% or greater reduction in mean nocturic episodes per night (37.9% with 0.83 mcg and 48.7% with 1.66 mcg vs 30.3% with placebo, p = 0.0227 and <0.0001, respectively) as well as for all secondary end points in the pooled analyses. The 1.66 mcg dose demonstrated significant improvements in the INTU score (p = 0.0255). The incidence of hyponatremia, defined as serum sodium 125 mmol/l or less regardless of symptoms or less than 130 mmol/l with symptoms, was 1.1%, 0% and 0.2% in the 1.66 and 0.83 mcg, and placebo groups, respectively. Other adverse events were similar across treatment groups.. SER120 demonstrated significant improvements over placebo for co-primary and secondary efficacy end points that corresponded with quality of life improvements. SER120 at each dose had an acceptable safety profile.

Topics: Aged; Aged, 80 and over; Antidiuretic Agents; Deamino Arginine Vasopressin; Double-Blind Method; Female; Humans; Male; Middle Aged; Nasal Sprays; Nocturia; Treatment Outcome

We investigated the efficacy and safety of desmopressin add-on therapy for men with persistent nocturia on α-blocker for lower urinary tract symptoms in this placebo controlled study.. The study included men 40 to 65 years old with lower urinary tract symptoms and persistent nocturia despite α-blocker therapy for at least 8 weeks. Patients were randomized to once daily placebo or desmopressin 0.2 mg for 8 weeks. The primary end point was to assess changes in the mean number of nocturia episodes from baseline to the final assessment. Other secondary end points and adverse events were evaluated.. A total of 86 patients were randomized to treatment, including placebo in 39 and desmopressin 0.2 mg in 47. Baseline characteristics were similar in the 2 groups. The desmopressin add-on group was significantly superior to placebo in terms of the change from baseline in the mean number of nocturia episodes (-1.13 ± 0.92 vs -0.68 ± 0.79, p = 0.034), the changes in nocturnal urine volume (p <0.001), total I-PSS (International Prostate Symptom Score) (p = 0.041), the nocturnal polyuria index (p = 0.001) and ICIQ-N (International Consultation on Incontinence Questionnaire-Nocturia) (p = 0.001), and the willingness to continue (p = 0.025). The incidence of adverse events in the desmopressin add-on group was similar to that in the placebo group. Most adverse events were mild.. Desmopressin add-on therapy in men 40 to 65 years old with persistent nocturia on α-blocker monotherapy for lower urinary tract symptoms is effective and well tolerated.

Topics: Adrenergic alpha-Antagonists; Adult; Antidiuretic Agents; Deamino Arginine Vasopressin; Double-Blind Method; Drug Therapy, Combination; Humans; Male; Middle Aged; Nocturia; Placebos; Polyuria; Quality of Life; Treatment Outcome

To explore risk factors for desmopressin-induced hyponatraemia and evaluate the impact of a serum sodium monitoring plan.. This was a meta-analysis of data from three clinical trials of desmopressin in nocturia. Patients received placebo or desmopressin orally disintegrating tablet (ODT; 10-100 μg). The incidence of serum sodium <130 mmol/L was recorded by age, sex and dose. Potential predictors of clinically significant hyponatraemia were identified using multivariate analysis in a Cox proportional hazards model.. Dose, age, baseline serum sodium level and kidney function, according to estimated GFR clearance, were significant risk factors for hyponatraemia in both sexes; similar to the known risk factors associated with hyponatraemia in the general population. In men, arthritis and use of drugs for bone disease were also predictive of hyponatraemia, while in women, raised monocytes and absence of lipid-modifying drugs increased the risk of hyponatraemia. Use of the proposed monitoring scheme and the minimum effective dose would have omitted all patients with clinically significant hyponatraemia from further treatment.. The incidence of hyponatraemia can be reduced by using minimum effective gender-specific dosing with the ODT formulation of desmopressin (25 μg in women, 50 μg in men). A sodium monitoring plan is proposed whereby baseline sodium must be ≥135 mmol/L (especially important in the elderly), with additional monitoring at week 1 and month 1 for those at elevated risk because they are aged ≥65 years or receiving concomitant medication associated with hyponatraemia. This monitoring plan would help to prevent some at-risk patients developing hyponatraemia; retrospective application of the monitoring plan showed that, once at-risk patients were appropriately screened out, only mild, non-clinically significant hyponatraemia was observed, within ranges of other drugs associated with hyponatraemia and similar to the background prevalence in the treatment population.

Topics: Adult; Aged; Aged, 80 and over; Antidiuretic Agents; Deamino Arginine Vasopressin; Double-Blind Method; Drug Monitoring; Female; Humans; Hyponatremia; Male; Middle Aged; Network Meta-Analysis; Nocturia; Retrospective Studies; Sodium; Young Adult

To evaluate the efficacy and safety of adding a low-dose oral desmopressin to tamsulosin therapy for treatment of nocturia in patients with benign prostatic hyperplasia (BPH).. Eligible patients with BPH and nocturia ≥2/night were randomly allocated to two treatment groups; the first of which received 3-month treatment scheme of daily oral dose of tamsulosin OCAS 0.4 mg and desmopressin MELT 60 mcg (D/T group), while the second one received tamsulosin OCAS 0.4 mg only (T group). Patients were followed on monthly basis and changes in the parameters from baseline to 3 months after treatment were assessed on I-PSS/QoL questionnaire, 7-day voiding diary, urinalysis, serum sodium, abdominal ultrasonography and uroflowmetry.. A total of 248 patients were included within the study; 123 patients in the combined D/T group and 125 patients in T group. The frequencies of night voids decreased by 64.3% in D/T group compared to 44.6% in T group. The first sleep period, significantly increased from 82.1 to 160.0 min and from 83.2 to 123.8 min in D/T and T group, respectively; and significant differences between both groups were observed at the end of study (p < 0.001). I-PSS, QoL score, post-void residual urine volume and Q max were significantly improved with no statistical difference between both groups. No serious adverse effects were reported in both groups.. The addition of low-dose oral desmopressin therapy to an α-blocker tamsulosin provides effective treatment for nocturia in patients with LUTS/BPH.

Topics: Administration, Oral; Aged; Aged, 80 and over; Antidiuretic Agents; Deamino Arginine Vasopressin; Dose-Response Relationship, Drug; Drug Therapy, Combination; Humans; Male; Middle Aged; Nocturia; Prostatic Hyperplasia; Sulfonamides; Tamsulosin; Treatment Outcome; Urine; Urological Agents

The higher sensitivity to desmopressin (dDAVP) found in women and older patients with nocturnal polyuria (NP) has partially been unraveled, leading to adaptation of the dosage based on gender. However, besides age and gender, other factors might play a role in differences in sensitivity and side effects. The aim of this study is to design a pharmacokinetic/pharmacodynamic (PD) assay to identify appropriate treatment for different groups of patients, primarily dependent on differences in age and gender.. This interventional pilot study was carried out in Ghent University Hospital, Belgium, between 2011 and 2013. Patients with NP were subjected to a water load test (15 mL/kg), as well as an administration of 120 µg dDAVP oral disintegrating tablet (ODT) followed by blood analysis to determine plasma dDAVP levels and urine analysis for diuresis rate, osmolality, free water clearance and sodium clearance.. Six female and six male patients were included (range 30-89 years old; mean age 69 years; SD 18). Three groups based on plasma dDAVP levels were found: (1) high (only women), (2) intermediate (only men) and (3) low plasma levels. For the nighttime samples (3-12 h after intake) men presented with significantly higher variation in PD response, whereas 12-15 h after dDAVP ODT intake women presented with a less predictable outcome, although all patients but one (female) have a prolonged PD effect.. This study suggests the need for individualized dose titration rather than fixed dose regimens in NP patients with bothersome symptoms. Gender, body weight and results of nocturnal free water and sodium clearance need to be taken into account for more accurate individualized treatment to result in high response rates and low side effects.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antidiuretic Agents; Belgium; Deamino Arginine Vasopressin; Female; Humans; Male; Middle Aged; Nocturia; Nocturnal Enuresis; Pilot Projects; Sex Factors; Tablets

To assess the effect of oral desmopressin on nocturia and nocturnal enuresis in patients after orthotopic neobladder reconstruction.. Of 55 patients who underwent radical cystectomy and orthotopic neobladder reconstruction at our medical centre in the period 2004-2011, 34 patients were deemed eligible for the present study. Inclusion criteria were estimated glomerular filtration rate >50 mL/min/1.73 m(2) , normal baseline sodium serum level, intact daytime urinary continence, and any degree of nocturia or nocturnal enuresis. Patients were treated daily with oral desmopressin 0.1 mg at bedtime for 30 days and completed the Nocturia, Nocturnal Enuresis and Sleep Interruption Questionnaire at trial enrollment and closure. Sodium serum levels were monitored throughout.. Three patients withdrew from the trial because of headaches or anxiety. The mean (sd) number of nocturnal voids decreased from 2.5 (1.4)/night at baseline to 1.5 (1.3)/night at trial closure (P = 0.015). The number of patients with one or no episodes of nocturnal enuresis per week increased from six to 12 (19 to 39%; P = 0.065). Thirteen patients (42%) reported an increase of a minimum 1-2 h of sleep until the first nocturnal void; all of them asked to continue the drug. No significant adverse events or changes in sodium level were observed.. Bedtime treatment with low-dose oral desmopressin appears to decrease episodes of nocturia and nocturnal enuresis effectively and safely in ∼50% of the patients with neobladder, allowing longer undisrupted sleep time and improved quality of life. Further investigation is warranted to determine if higher doses would result in a more meaningful clinical response.

Topics: Aged; Antidiuretic Agents; Cystectomy; Deamino Arginine Vasopressin; Female; Humans; Male; Middle Aged; Nocturia; Nocturnal Enuresis; Quality of Life; Surveys and Questionnaires; Urinary Diversion

To evaluate the efficacy of desmopressin on nocturia, quality of sleep (QoS), and health-related quality of life (HRQoL) in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) and nocturia due to nocturnal polyuria (NP) as the predominant symptom.. A German observational, multicenter, post-marketing surveillance study including men with LUTS/BPH and nocturia due to NP starting 3 months of desmopressin treatment.. In total, 137 patients with a mean of 3.8 nocturnal voids (range 2-7) were included. Desmopressin significantly reduced the mean number of nocturnal voids by 53 %, mean IPSS nocturia question by 50 %, and the mean ratio of night/24-h urine volume by 39 % from baseline to endpoint. The hours of undisturbed sleep significantly increased by 74 %; 71 % of men reported about undisturbed sleep of ≥4 h at study end. Additionally, there was a significant reduction in the Leeds Sleep Evaluation Questionnaire score, indicating a clinically relevant QoS improvement. This was associated with an improved HRQoL, as shown by a significant improvement in both the mean IPSS-QoL question by 43 % and mean ICIQ-N nocturia problem question by 53 %. Concomitant alpha-blocker use had no effect on the efficacy of desmopressin. The incidence of adverse events was low (2.2 %). Hyponatremia was not observed in any patient. The majority of patients and physicians rated the efficacy and tolerability of desmopressin as good/very good.. Desmopressin is an effective and well-tolerated treatment for nocturia due to NP in patients with LUTS/BPH in daily practice under routine conditions.

Topics: Aged; Aged, 80 and over; Antidiuretic Agents; Deamino Arginine Vasopressin; Humans; Lower Urinary Tract Symptoms; Male; Middle Aged; Nocturia; Polyuria; Prostatic Hyperplasia; Quality of Life; Sleep

Urology clinical trials assessing bladder function have relied on the self-reported duration of the first uninterrupted sleep period (FUSP) as a proxy outcome for sleep, but the relationship between this measure and more conventional self-reported measures of sleep is unknown. In this study, we examined the association between changes in FUSP and a widely used self-reported measure of sleep, the Pittsburgh Sleep Quality Index (PSQI).. We conducted post hoc (secondary) analyses of unpublished data from a previously published randomized clinical trial (NCT00477490) of desmopressin (a medication used to treat nocturia) and examined relationships between baseline and 4-week change in FUSP and PSQI global and subscale scores for participants (N = 580 to N = 606) having complete data.. Data indicated strong associations between change in PSQI global score and FUSP change in six of seven subscale scores. A reduction of 1.8 points in the PSQI global score was associated with a 72-min lengthening of FUSP.. Results suggest that FUSP is a potentially valuable metric that correlates with changes in perceived sleep duration, depth, quality for the entire night, efficiency, latency, and daytime function. An increase in FUSP was related to improvement in nearly all PSQI subscales. The validity of this measure in the general population remains to be determined.

Topics: Adult; Aged; Aged, 80 and over; Antidiuretic Agents; Deamino Arginine Vasopressin; Female; Humans; Male; Middle Aged; Nocturia; Sleep; Sleep Deprivation; Time Factors; Young Adult

We investigated the efficacy and safety of 50 and 75 μg desmopressin orally disintegrating tablets in men with nocturia (2 or more nocturnal voids).. In this 3-month, randomized, double-blind, parallel study 50 and 75 μg desmopressin were compared with placebo. The co-primary efficacy end points were changes from baseline in mean number of nocturnal voids and proportions of patients achieving at least a 33% reduction from baseline in nocturnal voids (33% responders) during a 3-month treatment period.. The full analysis set comprised 385 men (age range 20 to 87 years). The 50 and 75 μg doses significantly reduced the number of nocturnal voids (-0.37, p <0.0001 and -0.41, p = 0.0003, respectively) and increased the odds of a 33% or greater response (OR 1.98, p = 0.0009 and OR 2.04, p = 0.0004, respectively) compared with placebo during 3 months. Desmopressin 50 and 75 μg increased the time to first void from baseline by approximately 40 minutes compared to placebo (p = 0.006 and p = 0.003, respectively). The response to desmopressin was seen by 1 week of treatment and was sustained. Significant increases in health related quality of life and sleep quality were observed compared to placebo. Desmopressin was well tolerated as only 2 subjects (age 74 and 79 years) on 50 μg had a serum sodium level of less than 130 mmol/L (vs 9 subjects on 75 μg).. Desmopressin (orally disintegrating tablet) is an effective and well tolerated treatment for men with nocturia. Treatment with 50 μg desmopressin, the minimum effective dose, provided sustained improvement of nocturia throughout the study and meaningful benefits to patients with an improved safety profile.

Topics: Administration, Oral; Adult; Age Factors; Aged; Aged, 80 and over; Antidiuretic Agents; Deamino Arginine Vasopressin; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Follow-Up Studies; Humans; Male; Middle Aged; Multivariate Analysis; Nocturia; Patient Safety; Reference Values; Risk Assessment; Treatment Outcome; Young Adult

Previous studies suggest a lower dose of desmopressin orally disintegrating tablet may be effective in females compared to males with nocturia. We confirm the efficacy and safety of 25 μg desmopressin orally disintegrating tablet compared to placebo in female patients.. In this 3-month, randomized, double-blind, parallel group study 25 μg desmopressin once daily was compared to placebo in women with nocturia (2 or more nocturnal voids). The co-primary efficacy end points were change from baseline in mean number of nocturnal voids and proportion of patients achieving at least a 33% reduction from baseline in the mean number of nocturnal voids (33% responders).. The full analysis set comprised 261 patients (age range 19 to 87 years). Desmopressin significantly reduced the mean number of nocturnal voids and increased the odds of a 33% or greater response compared to placebo during 3 months, assessed by longitudinal analysis (-0.22, p = 0.028 and OR 1.85, p = 0.006, respectively). Desmopressin increased the mean time to first nocturnal void by 49 minutes compared to placebo at 3 months (p = 0.003). The response to desmopressin was seen by week 1 of treatment and was sustained throughout the trial. Significant increases in health related quality of life and sleep quality were observed compared to placebo. Desmopressin was well tolerated. Serum sodium levels remained greater than 125 mmol/L throughout the trial and 3 transient decreases to less than 130 mmol/L were recorded.. At a dose of 25 μg, desmopressin orally disintegrating tablet is an effective and well tolerated treatment for women with nocturia. Treatment provides rapid and sustained improvement in nocturia and quality of life.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antidiuretic Agents; Deamino Arginine Vasopressin; Dose-Response Relationship, Drug; Double-Blind Method; Drug Administration Schedule; Female; Follow-Up Studies; Humans; Middle Aged; Multivariate Analysis; Nocturia; Patient Safety; Reference Values; Risk Assessment; Severity of Illness Index; Treatment Outcome; Young Adult

We aimed to compare the effectiveness of intranasal desmopressin and doxazosin treatments in patients with nocturia and benign prostatic hyperplasia (BPH).. Thirty one men with BPH and three or more episodes of nocturia were randomized to receive 2 mg doxazosin at night for two weeks increasing to 4 mg for a further two weeks versus 20 μg intranasal desmopressin at night. For all patients, number of nocturia, urinary flow rate, residual urine volume and quality of life score were checked. Outcomes were measured at two months. The comparison of before and after treatment changes between the groups were done by student's t-test.. In doxazosin group, mean number of nocturia were 3.2 &plus mn; 0.4 (3-4 times) times per night and 1.2 +/- 0.8 (0-3 times) times per night before and after treatment, respectively. In desmopressin group, mean number of nocturia were 3.4 +/- 0.5 (3-4 times) and 1.5 +/- 0.6 (1-3 times) times per night before and after treatment, respectively. In doxazosin group, mean residual urine volumes were 44.3 +/- 35.9 ml (range 0-120 ml) and 23.1 +/- 18.8 ml (range 0-50 ml) before and after treatment, respectively. In desmopressin group, mean residual urine volumes were 36.6 +/- 32.4 ml (range 0-120 ml) and 14.0 +/- 26.9 ml (range 0-90 ml) before and after treatment, respectively. Improvements in number of nocturia, residual urine volume, quality of life scores and peak urinary flow rates weren't statistically significant between two groups, whereas change in international prostate symptom score (IPSS) score was more significant in doxazosin group.. Intranasal desmopressin, is an effective symptomatic treatment of men with BPH complaining of nocturia, as well as doxazosin treatment.

Topics: Administration, Intranasal; Adrenergic alpha-1 Receptor Antagonists; Antidiuretic Agents; Deamino Arginine Vasopressin; Doxazosin; Humans; Male; Middle Aged; Nocturia; Pilot Projects

To compare efficacy of desmopressin for treatment of nocturia between patients with normal and high nocturnal bladder capacity index (NBCi).. Retrospective analysis of adult patients treated with desmopressin for nocturia. Patients were analyzed according to high or normal NBCi value before treatment.. 55 patients were identified, aged 49-84, 47 males, 8 females, who started desmopressin 0.2 mg nocte between 2009 and 2011. Two groups (N: normal and H: high NBCi) were similar regarding number, gender, age, 24 h urine volume, and nocturnal urine volume. On treatment, nocturnal volume decreased by mean of 364 mL. Number of nightly voids decreased in N group from 3.11 to 1.50, in H from 3.96 to 1.44. Nocturnal polyuria and nocturia indices also decreased significantly. NBCi remained the same in N group (0.56 on therapy) and in H group decreased to mean 0.63. All on-treatment values were statistically similar in N and H groups. Pretreatment differences were abolished with treatment. NBCi was significantly correlated to nocturia reduction-larger reduction was observed in patients with higher NBCi. In 8/55 patients, hyponatremia was detected, but without clinical consequences.. The results indicate that the effectiveness of desmopressin on nocturia is not dependent upon the patient's pretreatment NBCi.

Topics: Aged; Aged, 80 and over; Antidiuretic Agents; Deamino Arginine Vasopressin; Female; Humans; Male; Middle Aged; Nocturia; Retrospective Studies; Treatment Outcome; Urinary Bladder

WHAT'S KNOWN ON THE SUBJECT? AND WHAT DOES THE STUDY ADD?: Desmopressin orally disintegrating tablet (ODT) 60-240 μg has proved an effective and well-tolerated antidiuretic treatment in male and female patients with nocturia. The main adverse event is hyponatraemia. Recent studies suggest that female patients are more sensitive to desmopressin ODT, achieving the same efficacy at lower doses than male patients. The study demonstrates the efficacy of desmopressin ODT in male and female Japanese patients with nocturia. It provides further evidence that the optimum desmopressin dose for the treatment of nocturia is lower in females than in males. Tailoring the dose according to gender provides an improved therapeutic window with the benefits of a decreased risk of hyponatraemia without compromising efficacy.. To establish the dose-response efficacy of desmopressin in a Japanese patient population for the treatment of nocturia. To explore gender differences in sensitivity to desmopressin in Japanese patients with nocturia.. A phase II multicentre, randomized, placebo-controlled, double-blind, parallel-group, comparative clinical trial was conducted. Subjects aged 55-75 years, with a mean of ≥2 voids per night, were included and randomized to receive placebo or one of four doses of desmopressin orally disintegrating tablet (ODT): 10 μg, 25 μg, 50 μg or 100 μg. The dose-response relationship of pharmacodynamic variables measured after a single dose of desmopressin administered to water-loaded subjects (treatment period 1) was compared with the primary clinical endpoint of change from baseline in mean number of nocturnal voids, after 28 days of desmopressin treatment (treatment period 2).. A total of 116 patients were treated in treatment period 1 of whom 113 qualified for treatment period 2, and 111 completed the study. In treatment period 1 a dose-response relationship was observed, both overall and in each gender group. Overall, the duration of antidiuretic action (DOA; time with urine osmolality >200 mOsm/kg) for the 25, 50 and 100 μg doses was 2 h (P = 0.010), 3.45 h (P < 0.001) and 5.74 h (P < 0.001), respectively; all statistically significant compared with placebo. Female patients were found to be more sensitive to desmopressin; DOA in female patients was longer than in male patients after desmopressin 25 and 50 μg. Extrapolation suggests that male patients require ∼58 μg to achieve similar DOA to females receiving 25 μg. A dose-response relationship was also seen in treatment period 2 for the group overall with a greater reduction in mean number of nocturnal voids from baseline to day 28 at higher doses, and with significant reductions in the 25- (P = 0.015) 50- (P < 0.001) and 100-μg (P = 0.001) dose groups compared with placebo. Similar dose-response relationships were also seen when the data were analysed by gender. Desmopressin ODT was well tolerated with no serious or severe adverse events.. A dose-response relationship for desmopressin ODT was shown in a population of Japanese patients with nocturia. The study suggests that the optimum desmopressin dose for the treatment of nocturia is lower in females than in males, indicating a gender-specific therapeutic window with a decreased risk of hyponatraemia without compromising efficacy on reduction of nocturnal voids. Further dose-finding studies are planned to confirm the recommended dose for the treatment of nocturia in a Japanese patient population.

Topics: Aged; Antidiuretic Agents; Deamino Arginine Vasopressin; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Male; Middle Aged; Nocturia; Sex Factors; Treatment Outcome

The primary objective was to investigate the efficacy of desmopressin orally disintegrating tablet versus placebo in patients with nocturia. Pharmacodynamics, safety and patient-reported quality of life (QoL) outcomes were also evaluated. One of several benefits of the new formulation is increased bioavailability. Exploring lower doses allows for a better evaluation of therapeutic effect versus tolerability.. This was a 4-week, randomized, double-blind study comparing 10, 25, 50, or 100 µg desmopressin versus placebo in adults with defined nocturia.. The intent to treat population comprised 757 patients experiencing ∼3 voids/night and a high prevalence of nocturnal polyuria (∼90%). Increasing doses of desmopressin were associated with decreasing numbers of nocturnal voids and voided volume, greater proportions of subjects with >33% reduction in nocturnal voids, and increased duration of first sleep period. The lowest dose reaching statistical significance (P < 0.05 vs. placebo) varied by endpoint. Improvements were clinically meaningful, meaning that patients actually had fewer nightly voids. Post hoc analyses by gender suggested a lower minimum effective dose for women. Desmopressin was generally well tolerated. Reductions in serum sodium to <125 mmol/L in six women (taking >25 µg desmopressin) and two men (aged 67 and 82) taking 100 µg, support lower and gender-specific dosing to reduce the small but clinically significant risk of hyponatraemia. Each void reduced/hour of sleep gained was associated with significant improvements in QoL.. Desmopressin orally disintegrating tablet is an effective and well-tolerated treatment for patients with nocturia. Further exploration of the lower dose range is warranted.

Topics: Administration, Oral; Aged; Aged, 80 and over; Antidiuretic Agents; Deamino Arginine Vasopressin; Double-Blind Method; Female; Humans; Male; Middle Aged; Nocturia; Surveys and Questionnaires; Treatment Outcome

The purpose of this study was to investigate efficacy, safety, and impact on quality of sleep of staggered furosemide and desmopressin in the treatment of nocturia in the elderly.. Patients aged >60 years with nocturia at least two voids per night were screened for enrollment into the study. A 3-week dose-titration phase established the optimum desmopressin dose (0.1, 0.2, or 0.4 mg). After a 1-week "washout" period, patients who showed sufficient response during the dose-titration period were randomized to receive staggered furosemide and the optimal dose of desmopressin or placebo in a double-blind design for 3 weeks. Voiding diaries were assessed before and after the treatment.. In all, 82 patients were randomized to either staggered furosemide and desmopressin (n=41) or placebo (n=41). In the study group, most patients reported a good response with both reduced nocturnal voids (3.5 vs. 2.0, P<0.01) and urine volume (919.6 ml vs. 584.2 ml, P<0.01). The mean duration of the first sleep period was improved by 70 min (133.6 vs. 203.2, P<0.01). Compared to placebo, staggered furosemide and desmopressin resulted in a significant reduction in the mean number of nocturnal voids (43% vs. 9%; P<0.01), nocturnal urine volume (37% vs. 5%; P<0.01), and increase in the mean duration of the first sleep period (52% vs. 19%, P<0.01). Adverse events were mild.. Staggered furosemide and desmopressin provide an effective and well-tolerated treatment for nocturia in the elderly.

Topics: Age Factors; Aged; Aged, 80 and over; China; Deamino Arginine Vasopressin; Diuretics; Double-Blind Method; Drug Administration Schedule; Drug Therapy, Combination; Female; Furosemide; Humans; Male; Middle Aged; Nocturia; Placebo Effect; Sleep; Time Factors; Treatment Outcome; Urodynamics

Increased age and female gender are well-known risk factors for the development of desmopressin-induced hyponatremia. However, little focus has been on exploring gender differences in the antidiuretic response to desmopressin. Based on an exploratory analysis from three clinical trials, we report a significant gender difference in the effects of desmopressin on nocturnal urine volume that could not be explained by pharmacokinetic differences. Mean desmopressin concentration profiles were tested for covariates, and age and gender were not statistically significant and only weight was significant for log(C(max)) (P = 0.0183) and borderline significant for log(AUC) (P = 0.0571). The decrease in nocturnal urine volume in nocturia patients treated with desmopressin over 28 days was significantly larger for women at the lower desmopressin melt doses of 10 and 25 μg than for men. The ED(50) for men was modeled to be 43.2 μg and 16.1 μg for women, with the ED(50) men/women estimated to be 2.7 (1.3-8.1 95% CI), corresponding to significantly higher sensitivity to desmopressin in women. An increasing incidence of hyponatremia with increasing dose was found, and at the highest dose level of 100 μg decreases in serum sodium were approximately twofold greater in women over 50 yr of age than in men. A new dose recommendation stratified by gender is suggested in the treatment of nocturia: for men, 50- to 100-μg melt is an efficacious and safe dose, while for women a dose of 25 μg melt is recommended as efficacious with no observed incidences of hyponatremia. Areas for further research are proposed to uncover pathophysiological mechanism(s) behind these gender differences.

Topics: Adolescent; Adult; Age Factors; Aged; Antidiuretic Agents; Controlled Clinical Trials as Topic; Cross-Over Studies; Deamino Arginine Vasopressin; Diuresis; Dose-Response Relationship, Drug; Double-Blind Method; Female; Humans; Hyponatremia; Male; Middle Aged; Nocturia; Risk Assessment; Risk Factors; Sex Factors; Sodium; Time Factors; Treatment Outcome; Urodynamics; Young Adult

To investigate the efficacy and safety of desmopressin in patients with mixed nocturia, Patients aged ≥ 18 yr with mixed nocturia (≥ 2 voids/night and a nocturnal polyuria index [NPi] >33% and a nocturnal bladder capacity index [NBCi] >1) were recruited. The optimum dose of oral desmopressin was determined during a 3-week dose-titration period and the determined dose was maintained for 4 weeks. The efficacy was assessed by the frequency-volume charts and the sleep questionnaire. The primary endpoint was the proportion of patients with a 50% or greater reduction in the number of nocturnal voids (NV) compared with baseline. Among 103 patients enrolled, 94 (79 men and 15 women) were included in the analysis. The proportion of patients with a 50% or greater reduction in NV was 68 (72%). The mean number of NV decreased significantly (3.20 to 1.34) and the mean nocturnal urine volume, nocturia index, NPi, and NBCi decreased significantly. The mean duration of sleep until the first NV was prolonged from 118.4 ± 44.1 to 220.3 ± 90.7 min (P<0.001). The overall impression of patients about their quality of sleep improved. Adverse events occurred in 6 patients, including one asymptomatic hyponatremia. Desmopressin is an effective and well-tolerated treatment for mixed nocturia.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antidiuretic Agents; Deamino Arginine Vasopressin; Drug Administration Schedule; Female; Humans; Male; Middle Aged; Nocturia; Polyuria; Prospective Studies; Sleep; Surveys and Questionnaires; Urinary Bladder; Urodynamics

To investigate efficacy, safety, and impact on quality of sleep of desmopressin in the treatment of nocturia.. Adults aged > or =18 yr with nocturia (> or =2 voids/night) received desmopressin tablets (0.1, 0.2, or 0.4 mg) during a 3-wk dose-titration period. Patients should show sufficient response during the dose-titration period (> or =20% reduction in nocturnal diuresis) and a return of nocturnal diuresis to > or =80% of baseline levels during washout. Eligible patients then entered a 3-wk double-blind treatment period and received either desmopressin or placebo.. 127 patients were randomised to either desmopressin (n=61) or placebo (n=66). Twenty (33%) desmopressin-treated patients compared with seven (11%) placebo-treated patients showed a clinical response, defined as a > or =50% reduction in the number of nocturnal voids compared with baseline (p=0.0014). Compared with placebo, desmopressin resulted in a significant reduction in the mean number of nocturnal voids (39% reduction with desmopressin vs. 15% with placebo; absolute difference -0.84, p<0.0001) and duration of the first sleep period (prolonged by 108 min with desmopressin vs. 41 min with placebo; p<0.0001). Quality of sleep was also improved with desmopressin versus placebo (statistically significant for one of the two parameters evaluated). Adverse events were mainly mild.. Oral desmopressin tablets provide an effective and well-tolerated treatment for nocturia. Compared with placebo, nocturnal voiding frequency is reduced, duration of the first sleep period is increased, and sleep quality may be improved.

Topics: Administration, Oral; Adult; Aged; Aged, 80 and over; Antidiuretic Agents; Deamino Arginine Vasopressin; Dose-Response Relationship, Drug; Double-Blind Method; Female; Follow-Up Studies; Humans; Male; Middle Aged; Nocturia; Sleep; Treatment Outcome; Urodynamics

To identify whether oral desmopressin (ddAVP) reduced nocturnal urine volume (NUV) in older men with nocturia without obvious bladder outlet obstruction and to determine whether deficiencies in arginine vasopressin (AVP) release and action demonstrated using water deprivation testing predicted responsiveness to ddAVP.. Participants had a 2-day Clinical Research Center (CRC) evaluation followed by a double-blinded, placebo-controlled, crossover trial of individually titrated oral ddAVP.. Participants were from a single Department of Veterans Affairs Medical Center.. Maximum urine osmolality and percentage increase in osmolality were measured after subjects received aqueous vasopressin as part of the overnight water deprivation study; these data were used to categorize participants as normal, having partial central AVP deficiency, or having impaired renal responsiveness to AVP. Response to ddAVP was assessed using data from frequency-volume records.. Fourteen participants completed the CRC stay and ddAVP trial. Subjects given ddAVP reduced NUV significantly from baseline (P=.02) and had significantly lower NUV than when on placebo (P=.01). The mean net reduction in NUV from ddAVP compared to placebo was 14+/-18%. Using water deprivation testing to categorize participants, 10 were normal, two had partial central AVP deficiency, and two had impaired renal responsiveness. The mean net reduction in NUV for those with abnormal water deprivation tests was 11+/-25%, versus 15+/-16% for those with normal water deprivation testing (P=.70).. In this small randomized, controlled trial in older men with nocturia, ddAVP reduced NUV. Counter to expectations, participants deemed normal according to water deprivation tests had approximately equivalent responsiveness to ddAVP. Although this study cannot offer definitive conclusions on the lack of prediction of water deprivation testing for ddAVP benefit, these data offer additional information that may help clarify the pathophysiology and optimal treatment of nocturia in older men.

Topics: Administration, Oral; Aged; Aged, 80 and over; Antidiuretic Agents; Arginine Vasopressin; Cross-Over Studies; Deamino Arginine Vasopressin; Double-Blind Method; Humans; Male; Nocturia; Pilot Projects; Severity of Illness Index; Water Deprivation

Increased calcium excretion due to desmopressin has been reported in children with nocturnal enuresis. Desmopressin is often used to treat adult patients with nocturnal polyuria. However, data on the effect of desmopressin on water/electrolyte excretion in adults are scarce. We present the short-term effects of desmopressin on water and electrolyte excretion in adult patients with nocturnal polyuria.. A total of 16 male patients with nocturnal polyuria, mean age 76.3 years, received 0.1 or 0.2 mg desmopressin before sleep. Frequency volume chart was recorded, and daytime and nighttime urine samples were collected separately before and after desmopressin administration. Urinary excretions of sodium, potassium and calcium were determined, and compared before and after treatment with desmopressin.. Desmopressin significantly increased urine osmolality, decreased nocturnal total urine volume, reduced the ratio of nocturnal urine volume-to-whole day urine volume and decreased nocturnal voiding frequency. Nocturnal urinary excretion of calcium (mean 0.137 vs 0.169 mg/kg body weight per hour, p = 0.004) and whole day excretion of calcium (mean 165.9 vs 200.0 mg per day, p = 0.012) were increased after desmopressin treatment. Nocturnal urinary potassium excretion (mean 0.030 vs 0.025 mEq/kg body weight per hour, p = 0.030) and whole day potassium excretion (mean 40.7 vs 36.1 mEq per day, p = 0.017) were decreased by desmopressin treatment. However, desmopressin treatment did not significantly change urinary secretion of sodium and chloride at nighttime or for the whole day.. Desmopressin reduces nocturnal urine volume and nocturnal voiding frequency in male patients with nocturnal polyuria. However, increased calcium and decreased potassium excretion following desmopressin treatment deserve attention particularly when it is used on a long-term basis.

Topics: Aged; Aged, 80 and over; Antidiuretic Agents; Calcium; Deamino Arginine Vasopressin; Drug Administration Schedule; Electrolytes; Humans; Male; Middle Aged; Nocturia; Polyuria; Potassium; Sodium; Water-Electrolyte Balance

There is no consistent opinion on the optimal initial dose of desmopressin for patients with nocturnal polyuria. Over a period of 12 weeks, we investigated the safety and efficacy of an initial dose of 50 μg of desmopressin for elderly men.. Eighty patients (mean age: 78.8 years) were started on an initial dose of 50 μg of desmopressin for nocturia associated with nocturnal polyuria. Safety and efficacy were evaluated after 1, 4, and 12 weeks using a frequency-volume chart, Athens Insomnia Scale, Patient Global Impression of Improvement scale, physical examination, blood tests, and a body composition analyzer.. Along with reduction in the frequency and volume of night-time urination, improvements in hours of undisturbed sleep, nocturnal polyuria index, and International Prostate Symptom Score, and Overactive Bladder Symptom Scores on quality of life measures were also observed. Hyponatremia was observed in 15 patients (18.7%). However, only 5.0% of patients had hyponatremia after the dose was reduced to 25 μg, and the continuation rate at 12 weeks was high at 87.5%. Age and other physical factors, such as body mass index, body water content, body fat mass, and muscle mass were not significant predictors of adverse events.. Our study suggests that an initial dose of 50 μg is more effective than a uniformly minimum dose based on factors such as age and physique. Furthermore, a high continuation rate can be achieved by appropriately reducing the dose, if adverse events occur.

Topics: Aged; Antidiuretic Agents; Deamino Arginine Vasopressin; East Asian People; Humans; Hyponatremia; Male; Nocturia; Polyuria; Quality of Life

Nocturnal enuresis (NE) is a common disease with multiple pathogenic mechanisms. This study aimed to compare levels of metabolites and proteins between wet and dry nights in urine samples from children with monosymptomatic NE (MNE).. Ten boys with MNE and nocturnal polyuria (age: 7.6 ± 1.3 years) collected their total nighttime urine production during a wet and a dry night. Untargeted metabolomics and proteomics were performed on the urine samples by liquid chromatography coupled with high-mass accuracy tandem mass spectrometry (LC-MS/MS).. On wet nights, we found reduced urine osmolality (P = 0.025) and increased excretion of urinary potassium and sodium by a factor of, respectively, 2.1 (P = 0.038) and 1.9 (P = 0.19) compared with dry nights. LC-MS identified 59 metabolites and 84 proteins with significantly different levels between wet and dry nights (fold change (FC) < 0.67 or > 1.5, P < 0.05). Some compounds were validated by different methodologies. During wet nights, levels of compounds related to oxidative stress and blood pressure, including adrenalin, were increased. We found reduced levels of aquaporin-2 on wet nights. The FCs in the 59 metabolites were positively correlated to the FCs in the same metabolites identified in urine samples obtained during the evening preceding wet and dry nights.. Oxidative stress, which in the literature has been associated with nocturia and disturbances in sleep, might be increased during wet nights in children with MNE. We further found evidence of increased sympathetic activity. The mechanisms related to having wet nights in children with MNE seem complex, and both free water and solute handling appear to be important. A higher resolution version of the Graphical abstract is available as Supplementary information.

Topics: Child; Chromatography, Liquid; Deamino Arginine Vasopressin; Humans; Male; Metabolome; Nocturia; Nocturnal Enuresis; Polyuria; Proteome; Tandem Mass Spectrometry

To clarify Japanese real-world clinical data on the use of desmopressin 25 and 50 μg orally disintegrating tablets (ODT) for male patients with nocturia and evaluate the predictive factors to improve nighttime frequency.. We retrospectively accumulated real-world clinical data from 27 institutions in Japan. Male patients with two or more episodes of nocturia who received desmopressin ODT for nocturnal polyuria (NP) from 2019 through 2021 were included. The primary endpoint was the change of nighttime frequency until 3 months after desmopressin administration. The secondary endpoints were to clarify the persistence rate, adverse events, and predictive factors of decreasing nighttime frequency.. A total of 118 patients were eligible to participate in this study. The persistence rate of desmopressin on the Kaplan-Meier curve at week 12 was 51.3. The reason for discontinuation was mainly the occurrence of adverse events in 67 patients (56.8%), particularly hyponatremia in 7 patients (5.9%). Nighttime frequencies at baseline, - 1 month and 1 - 3 months after desmopressin administration were 4.1 ± 1.3, 2.9 ± 1.4 (P < .01), and 2.6 ± 1.3 (P < .01), respectively. The mean nighttime urine volume voided at baseline was significantly larger in patients whose nighttime frequency decreased by two or more times than in those with a decrease of less than two times.. Desmopressin 25 and 50 μg ODT treatments are feasible for male patients with NP in Japanese real-world clinical practice. Patients with higher voided volumes, particularly in the nighttime, may have great benefit from desmopressin.

Topics: Deamino Arginine Vasopressin; Humans; Japan; Male; Nocturia; Retrospective Studies; Tablets

(Objective) Nocturia, an important male lower urinary tract symptom (LUTS), is often difficult to treat. Herein, we report our experience of the initial treatment of nocturia with the novel drug desmopressin. (Subjects and methods) Subjects included 25 patients with LUTS treated with desmopressin who had the chief complaint of nocturia. Before treatment, the frequency of nocturnal urination (≥2) and nocturnal polyuria index (≥0.33) were confirmed based on the urination diary for ≥ 72 h. Before sleep, 25 or 50 mg desmopressin (Minirin

Topics: Antidiuretic Agents; Deamino Arginine Vasopressin; Humans; Male; Nocturia; Polyuria; Quality of Life

Topics: Antidiuretic Agents; Contraindications; Deamino Arginine Vasopressin; Humans; Nocturia; Treatment Outcome

Topics: Aged; Aged, 80 and over; Deamino Arginine Vasopressin; Drug Prescriptions; Female; Humans; Male; Medicare Part D; Nocturia; Potentially Inappropriate Medication List; United States

Nocturia is one of the most bothersome lower urinary tract symptoms and often impairs sleep quality in the elderly. Although previous studies on nocturia have indicated that the successful treatment of nocturia improves sleep quality, most used questionnaires and activity devices to analyze sleep/wake patterns. Therefore, there is little information about the treatment effects of desmopressin on objective sleep quality. The aim of the DISTINCT study is to investigate the change in subjective and objective sleep quality using electroencephalography (EEG) and the Pittsburgh Sleep Quality Index (PSQI) after the administration of desmopressin in patients with nocturia due to nocturnal polyuria.. A total of 20 male patients, ≥65 years old, with nocturnal polyuria, defined as a nocturnal polyuria index (NPi) (nocturnal urine volume / 24 h urine volume) value ≥0.33, will participate in this study. The participants must have a nocturnal frequency of ≥2 and the first uninterrupted sleep period (FUSP) must occur within < 2.5 h. Desmopressin 50 μg per day will be orally administered before going to bed for 4 weeks. Urinary frequency volume charts (FVC) and EEG will be recorded prior to treatment and at 1 week and 4 weeks after the initiation of treatment. The PSQI will be completed before and 4 weeks after treatment. The primary endpoint is the change from baseline in the mean time of slow-wave sleep (sleep stages N3 and N4) at 4 weeks. The secondary endpoints include the change in the mean value of each sleep variable, the mean delta power during the FUSP, the correlation between nocturnal urinary frequency and slow-wave sleep time, and the change in PSQI score before and after treatment.. The DISTINCT study will provide valuable evidence to indicate that oral desmopressin treatment for nocturnal polyuria prolongs the FUSP, resulting in the extension of slow-wave sleep time associated with sleep quality.. The Japan Registry of Clinical Trials ( jRCTs051190080 ). Registered 9 December, 2019.

Topics: Administration, Oral; Deamino Arginine Vasopressin; Electroencephalography; Humans; Male; Nocturia; Polyuria; Research Design; Sleep, Slow-Wave

We designed a retrospective, monocentric, observational study to assess the efficacy and short-term side effect profile of desmopressin, a synthetic analogue of antidiuretic hormone, in 42 elderly patients affected by nocturnal polyuria (NP), a subset of nocturia (nocturnal overproduction of urine at night), which is characterised by nocturnal urine volume (NVU) exceeding 33% of the 24-hours total urine output.. The subjects had NP and included 25 males, which had benign prostatic hyperplasia (12 out of 25 had been surgically or endoscopically operated) and 15 females that had increased urinary frequency, night-time voiding, loss of bladder control and recurrent bladder infections, due to perineal wall weakness and vaginal or bladder prolapse. Patients recorded the number of voids during waking hours using a digital continuous urine meter. The quality of life (QoL) and efficacy of desmopressin were assessed at baseline and 12 weeks after treatment using the International Consultation on Incontinence Questionnaire Nocturia Quality of Life Module (ICIQ-Nqol) and International Prostate Symptom Score questionnaire (IPPS-Q8). The dosage of desmopressin acetate varied according to the discretion of the physician, usually beginning with one tablet before going to bed at night for 3 months. The dose was increased at 1-week intervals if a reduction in the NVU or night-time frequency was not achieved.. We found that desmopressin treatment reduced the nocturnal voided volume (P < .0001), ICIQ-Nqol (P < .0001) and IPPS-Q8 (P < .0001). No significant serum sodium alterations or modifications in serum creatine, potassium, or body weight were observed in all the patients. No adverse effects were observed.. Our findings show efficacy of desmopressin in the elderly for NP treatment supporting further clinical trials in larger cohorts of patients.

Topics: Aged; Antidiuretic Agents; Deamino Arginine Vasopressin; Female; Humans; Male; Nocturia; Polyuria; Quality of Life; Retrospective Studies

The goal of this study was to determine if the US adult population with nocturia (waking from sleep at night to void) can easily take medications (desmopressin acetate) approved by the US Food and Drug Administration for nocturia. The study examined: (1) the prevalence of comorbid conditions, laboratory abnormalities, and concomitant medications that increase risk of desmopressin use; and (2) whether these factors are associated with age or nocturia frequency.. Using a cross-sectional analysis of four US National Health and Nutrition Examination Survey (NHANES) waves (2005-2012), a total of 4111 participants aged ≥50 years who reported ≥2 nightly episodes of nocturia were identified. The main outcome was frequency of contraindications and drug interactions as described in US Food and Drug Administration-approved prescribing information. These prescribing concerns were matched to examination findings, medical conditions, concomitant medications, and laboratory results of NHANES participants. The associations between prescribing concerns and nocturia severity and age groups were examined.. The mean participant age was 65.7 years (95% CI, 65.3-66.1), and 45.5% were male. Desmopressin prescribing concerns were present in 80.5% (95% CI, 78.0-82.9) of those ≥50 years of age with nocturia; 50.0% (95% CI, 47.0-53.0) had contraindications, and 41.6% (95% CI, 39.3-44.0) took a concomitant drug that could increase risk of low serum sodium. Desmopressin contraindications were higher with older age (P < 0.001) and present in 73.2% (95% CI, 69.3-77.1) of those ≥80 years of age.. Using NHANES data, this study showed that older US adults with nocturia have a high prevalence of medical conditions, concomitant medications, and baseline laboratory abnormalities that likely increase the risk of potentially severe adverse side effects from desmopressin use. A medication designed and approved for a clinical symptom that is most common in older adults could not be taken by most of the older adults with the symptom.

Topics: Aged; Aged, 80 and over; Antidiuretic Agents; Comorbidity; Deamino Arginine Vasopressin; Drug Approval; Drug Interactions; Female; Humans; Male; Middle Aged; Nocturia; Nutrition Surveys; Polypharmacy; United States; United States Food and Drug Administration

Nocturia may be a multifactorial condition and should be regarded as a syndrome rather than a diagnosis, with many factors contributing to the clinical presentation. The effects of sleep deprivation can have a severely detrimental impact on the quality of life and productivity of the working age population, with considerable economic implications. Patients are unlikely to seek an appointment with their GP complaining of nocturia - they are more likely to complain of the effects of the condition, such as chronic tiredness, or injuries resulting from falls. The main criterion in deciding whether a patient should undergo further investigations into suspected nocturia is the degree to which the patient finds the condition bothersome. In some patients, lifestyle modifications may be an effective way to manage nocturia before medication is considered. As the only licensed product for all adults including those over 65 years of age, low dose desmopressin (Noqdirna

Topics: Algorithms; Antidiuretic Agents; Deamino Arginine Vasopressin; Deprescriptions; Diet, Sodium-Restricted; Drinking Behavior; Drug-Related Side Effects and Adverse Reactions; Humans; Life Style; Nocturia

Desmopressin was approved by the Food and Drug Administration (FDA) in 1978 for use in diabetes insipidus and bleeding disorders, but it is also prescribed off-label for patients with nocturia. Quantifying the potential risks facing adult patients taking desmopressin has taken on added importance because a new intranasal formulation of desmopressin was approved by the FDA in 2017. Like the old formulation, the main active ingredient is desmopressin acetate, but the new formulation also contains an excipient designed to enhance absorption. Our objective was to quantify the rate of hyponatremia in routine clinical care for patients prescribed the older formulation of desmopressin.. We conducted a population-based new-user cohort study from 1 February 2006 to 1 February 2017 using a nationwide commercial health plan database. Patients newly prescribed the older formulation of desmopressin were propensity-score (PS)-matched to patients newly prescribed oxybutynin. As a sensitivity analysis, tamsulosin was used as the comparator rather than oxybutynin. The primary outcome was a primary position diagnosis of hyponatremia. Proportional hazard models after 1:1 PS matching were used to estimate hazard ratios (HRs) and 95% confidence intervals (CI). We identified 3,137 adults who were newly prescribed desmopressin and matched them to 3,137 adults who were newly prescribed oxybutynin. Mean age was 70, 55% were male, 13% filled a prescription for a diuretic during the baseline time period, and the mean baseline sodium prior to receiving either study drug was 140 mmol/L (normal: 135-145). The rate of hyponatremia was 146 per 1,000 person-years for adults prescribed desmopressin compared to 11 per 1,000 person-years for adults prescribed oxybutynin, corresponding to a 13-fold higher rate (HR 13.19; 95% CI 6.69, 26.01; p < 0.01). When follow-up was truncated at 30 days, a similar increased rate was observed (HR 19.41; 95% CI 7.11, 52.99; p < 0.01). A higher rate of hyponatremia was also observed with desmopressin when tamsulosin was the comparator (HR 12.10; 95% CI 6.54, 22.37; p < 0.01). Important limitations of our study include unmeasured confounding (for example, over-the-counter medication use, dietary intake), missing data (i.e., only 20% of patients had a baseline serum sodium), and a lack of data on the newer formulation of desmopressin.. Use of an older formulation of desmopressin was associated with a marked increased rate of subsequent hyponatremia compared to use of other medications indicated for lower urinary tract symptoms. Such risks should be clearly communicated to patients prescribed this formulation of desmopressin.

Topics: Administration, Intranasal; Aged; Aged, 80 and over; Cohort Studies; Deamino Arginine Vasopressin; Female; Hemostatics; Humans; Hyponatremia; Male; Mandelic Acids; Middle Aged; Nocturia; Propensity Score; Proportional Hazards Models; Risk Factors; Tamsulosin; Treatment Outcome

This study investigated how desmopressin is prescribed to adults in Denmark.. All adult users of desmopressin over an 8-year period were identified from the Danish National Prescription Registry. Adult patients with nocturia or nocturnal enuresis (NE) were identified by indication codes for "frequent nocturnal voiding" or "involuntary nocturnal voiding", respectively. Patient demographics, desmopressin formulation and dose, and concomitant medication were investigated.. In all, 13 871 adults with nocturia and 2872 adults with chronic (i.e. >10 prescriptions) NE were given 102 547 and 43 712 desmopressin prescriptions, respectively. Across the entire patient cohort, 57% were women and mean patient age was 62 years. Over 40% of prescriptions were to elderly patients (≥65 years), and desmopressin use for adult enuresis increased with age. Orally disintegrating tablets were the most frequently used formulation (57%-65% of prescriptions), and a greater proportion of women than men used low-dose desmopressin (60 μg). Concomitant use of painkillers (opioids: 18%-26.7% of prescriptions; non-steroidal anti-inflammatory drugs: 14.2%-16.4% of prescriptions) and antidepressants (14.4%-18.1% of prescriptions) was common in both conditions, and 5.4%-9.2% of concomitant prescriptions were for overactive bladder medications.. This study provides insights into desmopressin use among Danish adults. Nearly half the prescriptions were to patients aged ≥65 years, despite historical manufacturer recommendations that desmopressin be restricted to patients <65 years of age. NE is considered a childhood condition, but desmopressin use for adult NE increased with age. A greater proportion of desmopressin prescriptions to women than men were for the lowest dose, consistent with greater sensitivity to desmopressin in women.

Topics: Adolescent; Adult; Age Factors; Aged; Aged, 80 and over; Antidiuretic Agents; Deamino Arginine Vasopressin; Denmark; Drug Prescriptions; Female; Humans; Male; Middle Aged; Nocturia; Nocturnal Enuresis; Registries; Sex Factors; Young Adult

To characterize the current evaluation, and efficacy of treatments in patients with the primary complaint of nocturia.. A retrospective chart review was performed of new patient encounters seen in a tertiary urology practice from May 2010 to September 2016 with the primary diagnosis of nocturia (ICD-9 788.43 and ICD-10 R35.1).. 595 patients were identified. 403 met inclusion criteria. The median patient reported that nocturia episodes were 4 (1-20). 192 patients (48%) reported previous treatment for nocturia. After the index visit, a bladder diary (BD) was utilized in 50% of patients, with a 62% (n = 124) completion rate at follow-up visit. On BD analysis, the most common etiologies of nocturia were nocturnal polyuria 76% (n = 90) and overactive bladder in 21% (n = 26). Patient reported improvement with therapy after BD completion was 46% (n = 34), similar to patients without voiding diaries (43% improvement, n = 153). Anticholinergics and alpha blockers were the most commonly recommended drug, but no specific medication was associated with nocturia improvement. Oral desmopressin was used in 5% of patients.. Nocturia is a common condition and very commonly patients have sought treatment prior to presentation. Bladder diaries were recommended to half of the patients. Patient reported that improvement did not seem to correlate with completion of a bladder diary. Though most patients had NP the use of desmopressin was very low. Current treatments used in managing nocturia may lack efficacy.

Topics: Adrenergic alpha-Antagonists; Adult; Aged; Aged, 80 and over; Antidiuretic Agents; Cholinergic Antagonists; Deamino Arginine Vasopressin; Female; Humans; Male; Medical Records; Middle Aged; Nocturia; Polyuria; Retrospective Studies; Urinary Bladder, Overactive; Young Adult

Patients with nocturia have to face many hurdles before being diagnosed and treated properly. The aim of this paper is to: summarize the nocturia patient pathway, explore how nocturia is diagnosed and treated in the real world and use the Delphi method to develop a practical algorithm with a focus on what steps need to be taken before prescribing desmopressin.. Evidence comes from existing guidelines (Google, PubMed), International Consultation on Incontinence-Research Society (ICI-RS) 2017, prescribing information and a Delphi panel (3 rounds). The International Continence Society initiated this study, the authors represent the ICI-RS, European Association of Urology, and Society of Urodynamics, Female Pelvic Medicine and Urogenital Reconstruction (SUFU).. Diagnostic packages: consensus on, history taking for all causalities, intake diary (fluid, food) and bladder diary, not for its duration. Pelvic (women) or rectal (men) examination, prostate-specific antigen, serum sodium check (SSC), renal function, endocrine screening: when judged necessary. Timing or empty stomach when SSC is not important. Therapeutic packages: the safe candidates for desmopressin can be phenotyped as no polydipsia, heart/kidney failure, severe leg edema or obstructive sleep apnea syndrome. Lifestyle interventions may be useful. Initiating desmopressin: risk management consensus on three clinical pictures. Follow-up of desmopressin therapy: there was consensus on SSC day 3 to 7, and at 1 month. Stop therapy if SSC is <130 mmol/L regardless of symptoms. Stop if SSC is 130 to 135 mmol/L with symptoms of hyponatremia.. A summary of the nocturia patient pathway across different medical specialists is useful in the visualization and phenotyping of patients for diagnosis and therapy. By summarizing basic knowledge of desmopressin, we aim to ease its initiation and shorten the patient journey for nocturia.

Topics: Adult; Aged; Antidiuretic Agents; Consensus; Deamino Arginine Vasopressin; Female; Humans; Life Style; Male; Middle Aged; Nocturia; Societies; Urodynamics

Topics: Antidiuretic Agents; Deamino Arginine Vasopressin; Humans; Nocturia; Polyuria; Tablets

Hyponatraemia is a well-known side effect of desmopressin therapy. Nocturia in elderly patients can be treated with desmopressin, which usually induces mild and reversible hyponatraemia. This case report is about two patients, in which severe hyponatriaemia, at least partly induced by desmopressin, was observed. The patients were affected by nausea, vomiting and confusion. These symptoms are caused by brain swelling, which can result in coma and death. The case reports illustrate the importance in measuring baseline P-sodium concentration during therapy and examining current medication before prescribing desmopressin.

Topics: Aged, 80 and over; Antidiuretic Agents; Deamino Arginine Vasopressin; Female; Humans; Hyponatremia; Nocturia; Sodium

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.. Nykturie, definiert als Miktion von mindestens 1 Mal pro Nacht, ist eines der am häufigsten vorkommenden Symptome bei Männern mit benignem Prostatasyndrom (BPS) und oft Ursache für Arztkonsultationen. Nykturie ist für den Betroffenen nicht nur lästig, sondern auch für eine erhöhte Morbidität und Mortalität verantwortlich. Nykturie kann durch eine vermehrte Flüssigkeitsaufnahme, gesteigerte Diurese oder verminderte Blasenkapazität verursacht werden. Häufig liegen beim einzelnen Mann mehrere Ursachen vor, die nur durch systematische Abklärung detektiert und differenziert werden können. Das Blasentagebuch für drei Tage ist ein essenzieller Bestandteil bei der Abklärung der zugrundeliegenden Pathophysiologie, die Grundlage für eine rationelle Therapie der Nykturie darstellt. Behandlungsziele sind die Reduktion der Miktion auf weniger als 2 Mal pro Nacht, die Verlängerung der ersten Schlafphase auf über 4 Stunden, die durch den Schlafmangel ausgelöste verminderte Lebensqualität wieder herzustellen und die mit Nykturie assoziierte Morbidität und Mortalität zu senken. Liegt beim Patienten mit BPS eine funktionell reduzierte Blasenkapazität durch Restharnbildung vor, können α-Blocker, 5α-Reduktasehemmer, Phosphodiesterase Typ 5-Inhibitoren, Pflanzenextrakte oder Prostataoperationen (z. B. TURP) die Nykturiefrequenz signifikant senken. Liegt jedoch eine nächtliche Polyurie vor, wie bei 80 % der BPS-Patienten mit Nykturie nachgewiesen wurde, sollte das therapeutische Ziel die Verminderung des nächtlichen Urinvolumens sein. Bei Mangel des antidiuretischen Hormons (Arginin-Vasopressin) ist die Einnahme von Desmopressin vor dem Schlafengehen die erste Therapiewahl. Eine neue galenische Zubereitung von Desmopressin reduziert die Wahrscheinlichkeit der Hyponatriämie und kann daher auch bei Männern über 65 Jahre sicher eingesetzt werden. Eine Medikamentenkombination könnte bei Männern mit mehreren Ursachen für die Nykturie sinnvoll sein.

Topics: Aged; Deamino Arginine Vasopressin; Humans; Lower Urinary Tract Symptoms; Male; Middle Aged; Nocturia; Polyuria; Prostatic Hyperplasia; Quality of Life; Transurethral Resection of Prostate

Topics: Aged; Antidiuretic Agents; Deamino Arginine Vasopressin; Drug Industry; Geriatrics; Humans; Inappropriate Prescribing; Marketing; Nocturia; Societies, Medical; United States

Topics: Administration, Inhalation; Adult; Advisory Committees; Child; Deamino Arginine Vasopressin; Drug Approval; Humans; Hyponatremia; Nocturia; Product Surveillance, Postmarketing; United States; United States Food and Drug Administration

The American Urological Association (AUA) stands at the forefront of technology development and urological education for urologists and urological healthcare professionals worldwide. The 112th annual meeting brought together a wide range of researchers in the field of urology to access knowledge, up-to-date clinical guidelines and advances in research. The meeting consisted of plenary and moderated poster, podium and video sessions highlighting the latest research and advances in urological medicine. This report highlights some of the presentations on therapeutic developments for a range of urological conditions.

Topics: Acetanilides; Administration, Intranasal; Aged; Aged, 80 and over; Antibiotics, Antineoplastic; Carcinoma, Transitional Cell; Clinical Trials, Phase III as Topic; Deamino Arginine Vasopressin; Delayed-Action Preparations; Double-Blind Method; Drug Combinations; Humans; Hydrogels; Mitomycin; Multicenter Studies as Topic; Nocturia; Randomized Controlled Trials as Topic; Solifenacin Succinate; Thiazoles; United States; Urinary Bladder Neoplasms; Urinary Bladder, Overactive; Urology

Desmopressin has been used for many years in the treatment of diabetes insipidus, nocturnal enuresis (involuntary urination while asleep) and nocturia associated with multiple sclerosis (in adults aged up to 65 years); it has also been recommended in certain circumstances for the treatment of nocturia in men and women (previously, an unlicensed use).

Topics: Administration, Sublingual; Adult; Aged; Deamino Arginine Vasopressin; Dose-Response Relationship, Drug; Female; Humans; Male; Middle Aged; Nocturia; Polyuria; Treatment Outcome

We investigated the efficacy of desmopressin in elderly patients with nocturnal polyuria (NP) to evaluate its effects on sleep quality.. Patients with NP (defined as the nighttime urine production >33% of total 24-hour urine volume determined from a frequency-volume chart) were recruited. Desmopressin (0.2 mg) was treated orally at bedtime for 12 weeks. The participants completed the Medical Outcomes Study (MOS) Sleep Scale.. The mean patient age was 62.7 ± 13.0 (range 42-78 years). The mean symptom duration was 42.2 ± 39.7 months. The number of nocturia episodes (from 3.49 ± 1.83 to 2.03 ± 1.35, p = 0.01), nocturnal urine volume (p = 0.01), NP index (p = 0.01), and nocturia index (p = 0.01) decreased significantly after treatment with desmopressin. Among the MOS Sleep Scale categories, hours slept/night (p = 0.042), shortness of breath (p = 0.019), and adequacy of sleep (p = 0.001) changed significantly with a decrease in the number of nocturia episodes. Adverse events were mild.. Desmopressin is an effective treatment for NP and improved sleep quality in elderly men.

Topics: Adult; Aged; Antidiuretic Agents; Deamino Arginine Vasopressin; Humans; Male; Middle Aged; Nocturia; Polyuria; Prospective Studies; Quality of Life; Sleep; Treatment Outcome

Primary care physicians commonly see men or women with nocturia (or nocturnal polyuria). Nocturia can have a dramatic impact on a patient's physical and emotional quality of life, including work performance or ability to function, because of the interrupted sleep patterns. It has also been determined that the most important sleep interval is the time from first falling asleep until first awakening. Nocturia is one of the most common and most bothersome symptoms of lower urinary tract symptoms (LUTS). In a man, LUTS is most commonly caused by benign prostatic obstruction (BPO) related to the enlargement of the prostate. In a woman, the most common cause of LUTS is overactive bladder (OAB). This article first explores the different causes and types of nocturia, then describes how to diagnose different types of nocturia (including use of frequency-volume charts), and last, discusses different approaches for managing nocturia (including the use of desmopressin), depending on the type and cause.

Topics: Antidiuretic Agents; Deamino Arginine Vasopressin; Female; Humans; Life Style; Male; Nocturia; Physicians, Primary Care; Sex Factors

Experimental studies disrupting sleep and epidemiologic studies of short sleep durations indicate the importance of deeper and longer sleep for cardiometabolic health. We examined the potential beneficial effects of lengthening the first uninterrupted sleep period (FUSP) on blood glucose. Long-term data (≥3 months of treatment) were derived from three clinical trials, testing low-dose (10-100 µg) melt formulations of desmopressin in 841 male and female nocturia patients (90 % of which had nocturnal polyuria). We performed post hoc multiple regression with non-fasting blood glucose as dependent variable and the following potential covariates/factors: time-averaged change of FUSP since baseline, age, gender, race, ethnicity, baseline glucose, baseline weight, change in weight, patient metabolic status (normal, metabolic syndrome, type II diabetes), dose, follow-up interval, and time of random glucose sampling. Increases in FUSP resulted in statistically significant reductions in blood glucose (p = 0.0131), even after controlling for all remaining covariates. Per hour increase in time to first void was associated with glucose decreases of 1.6 mg/dL. This association was more pronounced in patients with increased baseline glucose levels (test of baseline glucose by FUSP change interaction: p < 0.0001). Next to FUSP change, other statistically significant confounding factors/covariates also associated with glucose changes were gender, ethnicity, metabolic subgroup, and baseline glucose. These analyses indicate that delaying time to first void may have beneficial effects on reducing blood glucose in nocturia patients. These data are among the first to suggest that improving sleep may have salutary effects on a cardiometabolic measure.

Topics: Aged; Antidiuretic Agents; Blood Glucose; Deamino Arginine Vasopressin; Diabetes Mellitus, Type 2; Female; Humans; Male; Metabolic Syndrome; Middle Aged; Nocturia; Sleep; Treatment Outcome; Urination

To evaluate the safety and efficacy of low-dose desmopressin in elderly men with and without nocturnal polyuria (NP) in real-life practice.. Patients with lower urinary tract symptoms (LUTS)/ benign prostate hyperplasia (BPH) who were≧ 65 years old with refractory nocturia were enrolled in this study. We retrospectively analysed elderly men treated with adding desmopressin to current medications for nocturia according to category of the baseline nocturnal urine volume. The 48-h frequency volume chart (FVC), International Prostate Symptom Score (IPSS) and quality of life (QoL) were initially assessed and re-evaluated 12 weeks later. Serum sodium level was checked 1 week, 4 weeks, and 12 weeks after initiation of desmopressin therapy or suspected hyponatremia event. The mean change in numbers of nocturnal voids was evaluated for efficacy of treatment.. A total of 136 patients were included with 55 in non-NP group and 81 in NP group. Hypertension was more common in NP group in regard of comorbidities. During treatment period, there were significant reductions of nocturnal voids from 4.22 ± 1.38 to 2.31 ± 0.98 (p < 0.001) in non-NP group and from 4.52 ± 1.23 to 2.07 ± 0.89 (p < 0.001) in NP group. The reduction in nocturnal voids was more significant in NP group (2.44 ± 1.15 vs. 1.91 ± 1.48, p = 0.003). The mean decrease in serum sodium levels were 3.89 ± 1.22 mmol/l (p < 0.001) in non-NP group and 4.69 ± 3.5 mmol/l (p < 0.001) in NP group at the extreme value.. Long-term treatment with low-dose desmopressin is safe and effective for nocturia with or without NP in elderly patients with LUTS/BPH during real-life practice. Patients should be well informed about the disease and are closely followed.

Topics: Aged; Aged, 80 and over; Antidiuretic Agents; Deamino Arginine Vasopressin; Humans; Male; Middle Aged; Nocturia; Polyuria; Prostatic Hyperplasia; Retrospective Studies

Topics: Circadian Rhythm; Deamino Arginine Vasopressin; Humans; Nocturia; Polyuria

Topics: Antidiuretic Agents; Deamino Arginine Vasopressin; Humans; Incidence; Nocturia

Topics: Antidiuretic Agents; Deamino Arginine Vasopressin; Humans; Nocturia

The aim of study was to evaluate the influence of ageing, lifestyle, and co morbid illnesses on treatment outcome of nocturia among men with BPH.. Patients with BPH on medical therapy of least 6 months and up to 48 months were interviewed. Nocturia episodes, co morbid illnesses, beverage intake frequency, medications and work history were documented. Body Mass Index (BMI), waist circumference (WC), prostate volume, and prostate specific antigen (PSA) were recorded. Treatment failure is defined as persistent nocturia despite on medical therapy for BPH.. In 156 patients, the prevalence of nocturia was 96.7% while nocturia of 2 or more was 85.9%. Factors associated with treatment failure was older age (p < 0.01), usage of diuretics (p = 0.03), and antimuscarinics (p < 0.01), while active working status (p < 0.01), use of desmopression (p = 0.01), and increased coffee intake (p = 0.02) were associated with nocturia improvement. Co-morbid illnesses, obesity, WC, alcohol intake, PSA, prostate volume, and use of BPH medical therapy did not influence treatment outcome.. Advancing age has a significance negative outcome on nocturia treatment, while standard BPH medical therapy and co morbid illnesses have an insignificant impact. However, alleviation of bothersome symptoms is possible with the understanding of its patho-physiology and individual-based approach to treatment and expected outcome.

Topics: 5-alpha Reductase Inhibitors; Adrenergic alpha-Antagonists; Aged; Aging; Antidiuretic Agents; Body Constitution; Comorbidity; Cross-Sectional Studies; Deamino Arginine Vasopressin; Drug Combinations; Humans; Life Style; Male; Middle Aged; Muscarinic Antagonists; Nocturia; Prostatic Hyperplasia; Risk Factors; Treatment Outcome

Desmopressin is used for treating nocturnal polyuria, but hyponatremia is an associated concern in the elderly due to impaired urinary dilution. This study was undertaken to characterize hyponatremia occurring in adults using desmopressin for nocturnal polyuria.. Data from 172 patients who were prescribed desmopressin for nocturnal polyuria at a urology clinic from September 2010 through February 2013 were retrospectively analyzed. Demographic and laboratory parameters were investigated to examine the risk factors for desmopressin-associated hyponatremia.. The average follow-up serum sodium measured 21 ± 22 days after using desmopressin was 138 ± 5 mmol/l. Hyponatremia (<135 mmol/l) was found in 24 patients (14%), and it was severe in 7 (<126 mmol/l). In the hyponatremic patients, serum sodium decreased by 11 ± 6 mmol/l. Patients with hyponatremia were older than those with normonatremia (78 ± 7 vs. 68 ± 9 years, p < 0.0001). The presence of either hyponatremia-predisposing comorbidities or concurrent medications was associated with hyponatremia. Patients with hyponatremia had lower basal hemoglobin (11 ± 2 vs. 13 ± 2 g/dl, p < 0.001) and serum sodium (139 ± 2 vs. 140 ± 2 mmol/l, p < 0.05) than those with normonatremia. Multivariate logistic regression after adjustment for basal serum sodium showed that advanced age (OR 1.15; 95% CI 1.03-1.27) and lower hemoglobin level (OR 0.64; 95% CI 0.43-0.94) were independently associated with hyponatremia.. Hyponatremia is not infrequently associated with desmopressin use. Those with advanced age (≥65 years) and lower hemoglobin are at risk of desmopressin-associated hyponatremia and need to be carefully monitored.

Topics: Adult; Age Factors; Aged; Aged, 80 and over; Antidiuretic Agents; Comorbidity; Deamino Arginine Vasopressin; Female; Hemoglobins; Humans; Hyponatremia; Logistic Models; Male; Middle Aged; Nocturia; Polyuria; Retrospective Studies; Risk Factors; Sodium

Topics: Antidiuretic Agents; Deamino Arginine Vasopressin; Female; Humans; Male; Nocturia

Topics: Antidiuretic Agents; Deamino Arginine Vasopressin; Female; Humans; Nocturia

Desmopressin is used widely to treat nocturnal polyuria (NP), but there is concern of hyponatremia especially in elderly patients. This study aimed to evaluate the safety and efficacy of long-term desmopressin treatment in elderly patients with NP.. Patients who were ≥65 years old with NP were analyzed. All patients were started on 0.1 mg desmopressin, and the dose was escalated to 0.2 mg depending on patient symptoms. All patients were educated the mechanism of desmopressin. The voiding diary and serum sodium levels were evaluated at baseline, 3-7 days after starting treatment and every 3-6 months. Safety was evaluated by hyponatremia, hyponatremic symptoms and other adverse drug events. The mean changes in number of nocturia and nocturnal urine volume (NUV) were evaluated for efficacy.. A total of 68 patients were included. The mean age was 72.6 (66-85) years. The mean night-time frequency was 3.0 ± 1.8 day, and the mean serum sodium level was 141.2 ± 2.1 mEq/L at baseline. The mean follow-up period was 27.9 months. The mean decrease in serum sodium level was 1.3 ± 3.4 mEq/L at the last follow-up (p = 0.003). Hyponatremia incidence was 4.4 %, and all patients recovered by stopping medication. Severe adverse events were not observed. The mean night-time frequency had decreased by 2.1, and the NUV had decreased by 374.2 ± 261.3 mL at the last follow-up (p < 0.001).. Desmopressin at doses below 0.2 mg is safe and effective in elderly patients with NP if patients are well informed and are closely followed up.

Topics: Aged; Aged, 80 and over; Antidiuretic Agents; Deamino Arginine Vasopressin; Female; Follow-Up Studies; Humans; Hyponatremia; Male; Nocturia; Sodium; Time Factors

To assess the effect of desmopressin on serum testosterone level in men with nocturia and late onset hypogonadism.. We prospectively enrolled men with nocturia and symptoms of late onset hypogonadism. Desmopressin (0.1 mg) was administered once daily to patients for 12 weeks, and we then compared serum testosterone levels, electrolytes, frequency volume chart indices, and changes in the International Prostate Symptom Score (IPSS), International Index of Erectile Function, and Aging Male's Symptom scales before and after treatment. Patients with a history of cardiovascular disease or hyponatremia, those using hypnotics, and those who had primary hypogonadism or hypogonadotrophic hypogonadism were excluded from the study.. Sixty-two men (mean age, 68.4 years) completed pre- and post-treatment questionnaires and underwent laboratory testing. At the end of the study, the testosterone levels in men with low testosterone levels (<3.5 ng/mL) increased after the 12-week desmopressin treatment (2.85 ± 0.58 to 3.97 ± 1.44 ng/mL; P = .001). Mean scores had decreased from 17.7 to 13.9 (IPSS), 3.8 to 3.2 (IPSS-Quality of Life), and 33.7 to 31.1 (Aging Male's Symptom). On the frequency volume chart, nocturnal urine volume, nocturnal polyuria index, actual number of nocturia events, nocturia index, and nocturnal bladder capacity index were significantly decreased.. Desmopressin improved nocturia and other urinary symptoms. Moreover, serum testosterone levels increased significantly in men with low testosterone levels after 12-week desmopressin treatment.

Topics: Aged; Aging; Deamino Arginine Vasopressin; Electrolytes; Humans; Hypogonadism; Male; Middle Aged; Nocturia; Penile Erection; Prospective Studies; Quality of Life; Surveys and Questionnaires; Testosterone

Nocturia, or waking at night to void, is a common symptom that leads to substantial morbidity. Men and women are both affected across a wide age range, such that the objective evaluation of nocturia remains a challenge, due largely to its multifactorial etiology. While for some patients, nocturia is caused by common structural conditions such as prostatic obstruction, for others it is due to a complex interplay between multiple underlying systemic diseases. For this reason, persistent nocturia merits particularly careful consideration. The purpose of this review is to describe the most recent salient research in the field of nocturia, with a particular emphasis on its evaluation and management.

Topics: Adrenergic alpha-Antagonists; Antidiuretic Agents; Botulinum Toxins, Type A; Deamino Arginine Vasopressin; Drinking Behavior; Female; Humans; Male; Muscarinic Antagonists; Nocturia; Quality of Life

Topics: Aged; Antidiuretic Agents; Deamino Arginine Vasopressin; Female; Humans; Incidence; Male; Middle Aged; Nocturia; Quality of Life; Severity of Illness Index; Treatment Outcome; Wakefulness

Topics: Antidiuretic Agents; Deamino Arginine Vasopressin; Female; Humans; Male; Nocturia

Alpha-blockers improve lower urinary tract symptoms associated with benign prostatic obstruction. Nocturia, a storage symptom, is a common complaint in men. However, it does not fully respond to α-blocker therapy, likely due to its multifactorial pathophysiology. We evaluated the efficacy and safety of desmopressin as add-on therapy for refractory nocturia in men previously treated with an α-blocker for lower urinary tract symptoms.. Eligible patients were men 50 years old or older with lower urinary tract symptoms and persistent nocturia despite α-blocker treatment for a minimum of 4 weeks. The optimum dose of oral desmopressin was determined during a 4-week dose titration period and this dose was maintained for 24 weeks. Flow volume charts, International Prostate Symptom Score total and subscores, uroflowmetry and post-void residual urine volume were assessed.. A total of 216 patients were enrolled in the study. Of these patients there were 158 (76%) with nocturnal polyuria, 15 (7.2%) with decreased nocturnal bladder capacity and 35 (16.8%) with nocturia due to both causes. The number of nocturnal voids significantly decreased from a baseline mean of 7.0 to 5.7 episodes for 3 days at the 24-week visit. The average International Prostate Symptom Score total and subscore significantly decreased by 4 weeks and were maintained at 24 weeks. In patients younger than 65 years, International Prostate Symptom Score voiding subscores were significantly improved at 24 weeks compared to those age 65 years or older.. Desmopressin add-on therapy for refractory nocturia in men previously treated with an α-blocker for lower urinary tract symptoms improved voiding symptoms as well as nocturia, storage symptoms.

Topics: Adrenergic alpha-Antagonists; Aged; Analysis of Variance; Cohort Studies; Confidence Intervals; Deamino Arginine Vasopressin; Dose-Response Relationship, Drug; Drug Administration Schedule; Drug Therapy, Combination; Follow-Up Studies; Humans; Lower Urinary Tract Symptoms; Male; Middle Aged; Nocturia; Prospective Studies; Prostatic Hyperplasia; Quality of Life; Risk Assessment; Severity of Illness Index; Treatment Outcome; Urodynamics

Desmopressin is occasionally used to reduce the frequency of nocturnal toilet visits. We describe an 86-year-old woman with nocturnal incontinence due to a urinary tract infection, and a 49-year-old man with frequent toilet visits in the night, known to consume excessive amounts of alcohol. They were admitted to hospital with neurological symptoms due to severe hyponatraemia, 114 and 102 mmol/l respectively, while using desmopressin. After the desmopressin had been discontinued and the fluid balance restored, they recovered completely. Hyponatraemia is inherent to the mechanism of action of desmopressin. Desmopressin should be prescribed only on sound indication, and risk factors for developing severe hyponatraemia should always be taken into consideration. Proper instruction and follow-up are important to prevent severe complications.

Topics: Aged, 80 and over; Deamino Arginine Vasopressin; Female; Humans; Hyponatremia; Male; Middle Aged; Nocturia

Nocturnal polyuria is a common but often overlooked cause of nocturia. We investigated the proportion of adults with 2 or greater voids nightly who had nocturnal polyuria in 2 cohorts from the United States and Europe.. Data on nocturnal polyuria were obtained from 3 or 7-day frequency-volume charts completed by patients as part of screening for inclusion in subsequent trials of nocturia therapy. Patients recorded the time and volume of each void. Nocturnal polyuria was defined as nocturnal urine volume greater than 33% of 24-hour volume, including the first morning void.. In the first cohort 1,003 patients were screened, of whom 846 provided evaluable diary data, including 641 (76%) with nocturnal polyuria. Of the total screened population of 1,003 patients 641 (64%) had confirmed nocturnal polyuria. The prevalence of nocturnal polyuria increased with age but was high in all age groups. In the second cohort 1,412 patients were screened, of whom 917 provided evaluable diary data, including 806 (88%) with nocturnal polyuria. Of the total screened population of 1,412 patients 806 (57%) had confirmed nocturnal polyuria. The prevalence of nocturnal polyuria increased with age but was high in all age groups. Of 158 patients receiving benign prostatic hyperplasia and/or overactive bladder medication 141 (89%) had nocturnal polyuria. In each cohort the nocturnal polyuria prevalence was high in all ethnic groups (63% or greater).. In this large study nocturnal polyuria was present in most patients with nocturia regardless of gender, age, ethnicity, country and concomitant benign prostatic hyperplasia/overactive bladder therapy.

Topics: Antidiuretic Agents; Circadian Rhythm; Deamino Arginine Vasopressin; Female; Humans; Male; Middle Aged; Nocturia; Polyuria; Randomized Controlled Trials as Topic

Topics: Antidiuretic Agents; Deamino Arginine Vasopressin; Epidemiologic Methods; Humans; Male; Nocturia; Quality of Life

Topics: Antidiuretic Agents; Deamino Arginine Vasopressin; Humans; Medical Records; Nocturia; Urination

Desmopressin, a synthetic analog of the antidiuretic hormone, is used in the treatment of enuresis nocturna in children and increasingly also in adults. Nocturia in the elderly causes sleeping disorders and is associated with a higher risk of falling and increased mortality. Desmopressin leads to a significant decrement of nocturia and consequently, a better sleep quality and is for this reason increasingly prescribed in the old. Desmopressin causes borderline hyponatremia (130-135 mmol/l) in 15% and severe hyponatremia in 5% of all adult users. Factors that predispose to hyponatremia are a higher dose, age > 65 years, a low-normal serum sodium, a high 24-hour urine volume and co-medication (thiazide diuretics, tricyclic antidepressants, serotonin-reuptake-inhibitors, chlorpromazine, carbamazipine, loperamide, Non-Steroidal-Anti-Inflammatory-Drugs). Hyponatremia is associated with headache, nausea, vomiting, dizziness, and can cause somnolence, loss of consciousness and death. We present two cases where initiation of desmopressin led to hyponatremia, requiring hospitalization. In view of the high risk of desmopressin-associated hyponatremia in the older population, alternative treatment strategies for nocturia must be considered first. If desmopressin is prescribed, strict follow-up of serum sodium levels is necessary.

Topics: Aged; Aged, 80 and over; Antidiuretic Agents; Deamino Arginine Vasopressin; Female; Humans; Hyponatremia; Nocturia; Risk Assessment; Risk Factors; Sodium

The aim of the study is to evaluate the efficacy of desmopressin therapy in the symptomatic treatment of nocturia in patients with multiple sclerosis (MS) and neurogenic detrusor overactivity, and to investigate the validity of maximal bladder capacity as a predictor of response to intranasal desmopressin inhalation.. A set of 20 women with MS and neurogenic detrusor overactivity enrolled in a prospective pilot study and were divided into two groups: Group A, the large bladder capacity group (maximal bladder capacity >250 ml, compliance >20 ml/cm H(2)O, n=10) and Group B, the small bladder capacity group (maximal bladder capacity <250 ml, compliance <20 ml/cm H(2)O, n=10). Maximal bladder capacities were measured by urodynamic evaluation. The dosage selected for the study was based on the established dose of commercially available desmopressin nasal spray (20 mug before bedtime) and on clinical trial experience. All patients were monitored for arterial blood pressure before and after treatment and for weight increase for the first 5 days of treatment. Night time voiding diaries were maintained for the 6 weeks of the trial; similarly, serum electrolyte levels and urine osmolality were measured twice weekly during the trial.. The mean volume of nocturnal incontinence decreased significantly in both groups (P<0.005). The average number of episodes of nocturia per night in Group A decreased from 2.35 to 0.89 and in Group B from 2.31 to 1.65. The maximum hours of sleep uninterrupted by nocturia increased from 2.54 to 4.62 in Group A and from 2.45 to 3.23 in Group B. Side effects were infrequent; only 2 patients complained of transient headaches. Neither hyponatremia nor serum electrolyte abnormalities occurred.. Our results suggest that desmopressin is effective in the symptomatic management of nocturia in patients with MS and neurogenic detrusor overactivity. Maximal bladder capacity is a valuable predictor of response to desmopressin.

Topics: Administration, Intranasal; Antidiuretic Agents; Deamino Arginine Vasopressin; Female; Humans; Middle Aged; Multiple Sclerosis; Nocturia; Pilot Projects; Prospective Studies; Sleep; Time Factors; Treatment Outcome; Urinary Bladder; Urodynamics

The aims of this study were to analyze the prescription pattern of desmopressin before and after the new indication was approved for treatment of nocturia in the elderly in Sweden in 2002 and to analyze to what extent other drugs potentially inducing hyponatremia were prescribed in combination with desmopressin.. We conducted epidemiological analyzes of the Swedish Prescribed Drug Register from 2000 to March 2007. All patients older than 60 years who were prescribed desmopressin in Sweden during the study period were included.. A marked increase in filled prescriptions of desmopressin in elderly patients was noticed after the new approval in 2002. The therapeutic intensity peaked in 2005 and has thereafter markedly decreased. The magnitude of concurrent treatment with any of the following drugs was assessed: diuretics, tricyclic antidepressants, selective serotonin reuptake inhibitors (SSRI), chlorpromazine, carbamazepine, loperamide, and nonsteroid anti-inflammatory drugs. More than half of the patients on desmopressin during July 2005 and March 2007 filled a prescription of any of the potentially harmful drugs within 30 days of a filled prescription of desmopressin.. The use of desmopressin in the elderly after the new approval in 2002 showed a similar prescription pattern to any newly introduced drug or after a changed indication. A large part of the elderly on desmopressin also receives other drugs that are potentially harmful in combination with desmopressin. Increased awareness of potentially interacting concomitant medication can improve medication safety in this fragile group.

Topics: Aged; Databases, Factual; Deamino Arginine Vasopressin; Drug Interactions; Drug Prescriptions; Drug Utilization; Female; Humans; Hyponatremia; Male; Middle Aged; Nocturia; Renal Agents; Sweden

Against the background of the approval of the use of desmopressin in the treatment of nocturia in adults, the aim of the present study was to describe patterns of its use in elderly patients in Denmark from 2000 to 2004.. Data were obtained from the Danish Register of Medicinal Product Statistics on nationwide sales of desmopressin and two commonly used measures of drug utilisation: 1-year prevalence (number of patients treated at least once during 1 year/1000 inhabitants) and therapeutic intensity (Daily Defined Doses (DDD)/1000 inhabitants/day).. In 2002, the 1-year prevalence rose ranging from a 5-fold increase among men aged 60-69 years to a 14-fold increased prevalence in men >/=90 years. In women, relative increases of the same magnitude were noted. Similarly, marked increases of the therapeutic intensities were observed in both men and women in 2002, this was followed by steady growth in most age groups. By the end of the study period in 2004, the highest therapeutic intensities were observed in men (1.06 DDD/1000 inhabitants/day) and women (0.92 DDD/1000 inhabitants/day) aged 80-89 years.. After approval in 2002 of the use of desmopressin in the management of nocturia in adults, a substantial increased utilisation was observed in patients >/=80 years. Given the high prevalence of risk factors for hyponatremia in these elderly patients, the pattern of utilisation is noteworthy and may need to be reviewed.

Topics: Adult; Adverse Drug Reaction Reporting Systems; Age Factors; Aged; Antidiuretic Agents; Community Pharmacy Services; Deamino Arginine Vasopressin; Denmark; Drug Monitoring; Female; Humans; Hyponatremia; Male; Middle Aged; Nocturia; Prevalence; Registries; Reproducibility of Results; Risk Factors; Time Factors

We assessed the effects of long-term oral desmopressin on serum sodium and baseline antidiuretic hormone secretion in elderly patients with nocturia.. A total of 15 elderly male patients with severe nocturia (greater than 3 voids nightly) who did not show hyponatremia within 7 days of administration of 0.2 mg desmopressin were enrolled in this study. Desmopressin (0.2 mg) was administered orally nightly for 1 year. Before and 1 month after the 1-year medication 24-hour circadian studies were performed to monitor changes in antidiuretic hormone. Every 3 months during the 1-year medication serum changes and timed urine chemistry were monitored.. Desmopressin significantly decreased nocturnal urine output and the number of nocturia episodes (p<0.01). Compared to before treatment desmopressin gradually decreased serum sodium and induced statistically but not clinically significant hyponatremia after 6 months of treatment. After discontinuing desmopressin serum sodium returned to the normal range in all patients. There were no significant differences when baseline and posttreatment endogenous antidiuretic hormone were compared. No serious systemic complications were found during medication.. Long-term desmopressin administration gradually decreased the serum concentration and induced significant hyponatremia from 6 months in patients who did not show initial hyponatremia. Long-term administration of desmopressin for 1 year in elderly patients did not affect baseline antidiuretic hormone secretion. For long-term desmopressin administration serum sodium should be assessed regularly, at least every 6 months.

Topics: Aged; Aged, 80 and over; Antidiuretic Agents; Circadian Rhythm; Deamino Arginine Vasopressin; Humans; Middle Aged; Nocturia; Osmolar Concentration; Sodium; Vasopressins