Efficacy of desmopressin (Minirin) in the treatment of nocturia: a double-blind placebo-controlled study in women. Reducing nocturia in the elderly: a randomized placebo-controlled trial of staggered furosemide and desmopressin. Efficacy of desmopressin in the treatment of nocturia: a double‐blind placebo‐controlled study in men The impact of adding low-dose oral desmopressin therapy to tamsulosin therapy for treatment of nocturia owing to benign prostatic hyperplasia An open, in-patient incremental safety and efficacy study of desmopressin in women with multiple sclerosis and nocturia. Desmopressin in the treatment of nocturia: a double-blind, placebo-controlled study. Efficacy of desmopressin in treatment of nocturia in elderly men Desmopressin in the management of nocturia in patients with multiple sclerosis. A double-blind, crossover trial. Low dose oral desmopressin for nocturnal polyuria in patients with benign prostatic hyperplasia: a double-blind, placebo controlled, randomized study. Low‐dose Desmopressin and Tolterodine Combination Therapy for Treating Nocturia in Women with Overactive Bladder: A Double‐blind, Randomized, Controlled Study Desmopressin orally disintegrating tablet effectively reduces nocturia: results of a randomized, double-blind, placebo-controlled trial. Desmopressin in the treatment of nocturia and enuresis in patients with multiple sclerosis. Oral desmopressin for nocturnal polyuria in elderly subjects: a double‐blind, placebo‐controlled randomized exploratory study Clinical experiences with desmopressin for long-term treatment of nocturia.
OBJECTIVE The purpose of this study was to investigate the efficacy and safety of oral desmopressin in the treatment of nocturia in women . STUDY DESIGN Women aged 18 years or older with nocturia ( > or=2 voids per night with a nocturia index score > 1 ) received desmopressin ( 0.1 mg , 0.2 mg , or 0.4 mg ) during a 3-week dose-titration period . After a 1-week washout period , patients who responded in this period received desmopressin or placebo in a double-blind fashion for 3 weeks . RESULTS In double-blind phase , 144 patients were r and omly assigned to groups  ( desmopressin , n=72 ; placebo , n=72 ) . For desmopressin , 33 ( 46 % ) patients had a 50 % or greater reduction in nocturnal voids against baseline levels compared with 5 ( 7 % ) patients receiving placebo ( P<.0001 ) . The mean number of nocturnal voids , duration of sleep until the first nocturnal void , nocturnal diuresis , and ratios of nocturnal per 24 hours and nocturnal per daytime urine volumes changed significantly in favor of desmopressin versus placebo ( P<.0001 ) . In the dose-titration phase headache ( 22 % ) , nausea ( 8 % ) , and hyponatremia ( 6 % ) were reported . Two deaths occurred , although neither could be directly associated with the study drug . CONCLUSION Oral desmopressin is an effective and well-tolerated treatment for nocturia in women AIMS 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 . METHODS 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 r and omized 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 . RESULTS In all , 82 patients were r and omized 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 result ed 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 . CONCLUSIONS Staggered furosemide and desmopressin provide an effective and well-tolerated treatment for nocturia in the elderly Objective To investigate the efficacy and safety of oral desmopressin in the treatment of nocturia in men Abstract Purpose 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 ) . Methods Eligible patients with BPH and nocturia ≥2/night were r and omly 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 question naire , 7-day voiding diary , urinalysis , serum sodium , abdominal ultrasonography and uroflowmetry . Results 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 Qmax were significantly improved with no statistical difference between both groups . No serious adverse effects were reported in both groups . Conclusion The addition of low-dose oral desmopressin therapy to an α-blocker tamsulosin provides effective treatment for nocturia in patients with LUTS/BPH OBJECTIVES To examine the safety and efficacy of desmopressin in three doses given to women with multiple sclerosis to treat nocturia with or without enuresis . PATIENTS AND METHODS Eight women with clinical ly confirmed multiple sclerosis and nocturia with or without enuresis were entered as in- patients into an open , nonr and omized , placebo-controlled study of incremental doses of 20 , 40 and 60 micrograms desmopressin .  Urinary and serum sodium , plasma arginine vasopressin and urine osmolality were monitored every 4 h for 24 h. A single dose of placebo or desmopressin was given during each of four 24-h periods . RESULTS There was a significant decrease in nocturnal urinary volumes and a significant increase in nocturnal urinary osmolalities in patients taking desmopressin when compared with those taking a placebo , but there was no difference among the desmopressin doses . There was no significant difference in serum sodium level between the desmopressin doses . However , at the end of the 24-h period with the 60 micrograms dose , serum sodium was decreased significantly . CONCLUSIONS Neither a significant decrease in nocturnal urinary volumes nor an increase in urinary osmolality was achieved by doses of desmopressin > 20 micrograms . A dose of 60 g was associated with a decreased serum sodium level at the end of the 24-h period but there was no biochemical hyponatraemia . Because there were no benefits and a possibility of clinical hyponatraemia with higher doses , doses of > 20 micrograms desmopressin can not be recommended OBJECTIVES To investigate efficacy , safety , and impact on quality of sleep of desmopressin in the treatment of nocturia . METHODS 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 . RESULTS 127 patients were r and omised 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 result ed 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 . CONCLUSIONS 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 BACKGROUND : Nocturia may be due to urological and non-urological diseases and some of the possible underlying non-urological diseases may be life-threatening . We investigated the efficacy and safety of lowest dose of oral desmopressin in treatment of nocturia in elderly men . METHODS : 60 old men referring to urology clinic of Imam Reza hospital in Tehran , Iran from 2008 - 2009 for treatment of nocturia were included in a double-blind placebo-controlled study . Patients were r and omly divided into 2 study groups ( 30 patients in each group ) . Care was taken to match the patients of the 2 groups by age and clinical criteria . They complained of about 2 voids per night . We divided the patients into 2 study groups . Patients belonging to group A ( n = 30 ) received placebo and patients of group B ( n = 30 ) received 0.1 mg desmopressin at bed time for 8 weeks . Patients were assessed after 4 and 8 weeks of treatment . The means were compared using paired sample t-test and chi-square test for time of nocturia before and after treatments and also between the two groups . ANOVA test was used for assessement of statistical differences between outcomes of the two groups . RESULTS : Mean number of nocturia before and after receiving desmopressin were 2.6 and 1.6 respectively which differed significantly ( p < 0.001 ) . Mean number of nocturia before and after receiving placebo were 2.5 and 2.3 respectively with no significant difference ( p = 0.344 ) . After 4 weeks of treatment with desmopressin , 17 patients ( 56.7 % ) had less than 2 voids , 5 patients ( 16.7 % ) had 2 voids and 8 ( 26.7 % ) had more than 2 voids per night ( p < 0.05 ) . After 8 weeks , patients were evaluated and it was noticed that in group B , 4 patients ( 13.3 % ) had 2 voids , 24 ( 80 % ) had less than 2 voids and 2 patients ( 6.7 % ) had more than 2 voids per night ( p = 0.004 ) . CONCLUSIONS : Oral administration of desmopressin is an effective and well-tolerated treatment for nocturia in elderly men BACKGROUND Neurogenic bladder affects up to 80 % of patients with multiple sclerosis ( MS ) and , in 50 % of these patients , it is a significant cause of disability . The current management of neurogenic bladder , based on fluid restriction , anticholinergic agents , intermittent self-catheterization , and , in some cases , surgical intervention , often fails to relieve all symptoms . Furthermore , anticholinergic drugs have significant adverse effects and may be medically contraindicated . Nocturia is a particularly disabling symptom of neurogenic bladder ; by disrupting sleep patterns , it aggravates the chronic fatigue of MS , imposes serious dem and s on caregivers , and can lead to institutionalization . To evaluate a novel approach to the symptomatic management of nocturia in patients with MS , we have conducted a trial of desmopressin acetate ( 1-desamino-8-D-arginine vasopressin ) , a synthetic analogue of antidiuretic hormone . OBJECTIVE To evaluate the efficacy and short-term safety of desmopressin therapy in the symptomatic treatment of nocturia in patients with MS . METHODS Seventeen patients were enrolled in a double-blind , crossover trial of desmopressin administered at bedtime . Patients with both relapsing-remitting and chronic-progressive forms of MS were admitted . Night time voiding diaries were maintained for the 6 weeks of the trial ; similarly , serum electrolyte levels and plasma osmolality were measured twice weekly and urinalyses and urine cultures were performed weekly during the trial . RESULTS Desmopressin reduced the percentage of nights with nocturia in patients from 97 % to 66 % . The average number of episodes of nocturia per night in patients decreased from 2.35 to 1.09 and the maximum hours of sleep uninterrupted by nocturia increased from 3.74 to 5.77 . These results were highly significant . Four of the 17 patients discontinued participation in the study after developing asymptomatic or minimally symptomatic hyponatremia . CONCLUSIONS Desmopressin was found effective ; no tolerance and only minimal adverse effects have been observed . Our results suggest that desmopressin , either alone or in combination with other therapeutic modalities , is effective in the symptomatic management of nocturia in patients with MS . The only adverse effect attributed to desmopressin was hyponatremia , which occurred in 4 of 17 patients and appeared to be dose related PURPOSE We evaluated the long-term efficacy and safety of low dose oral desmopressin in elderly patients with benign prostatic hyperplasia with more than nocturnal voids and nocturnal polyuria more than 30 % of total daily urine volume . MATERIAL S AND METHODS Eligible patients with benign prostatic hyperplasia older than 65 years with nocturia , nocturnal polyuria and International Prostate Symptom Score 14 or greater were included in the study . All patients received placebo or 0.1 mg desmopressin orally at bedtime . Patients were required to visit the outpatient clinic from the first visit , and after 1 , 3 , 6 and 12 months of treatment . Patients maintained flow volume charts and used diaries to record voiding data throughout the study . During followup urinalysis , urine sodium , urine osmolality , serum electrolytes , prostate specific antigen , International Prostate Symptom Score , quality of life , transrectal ultrasonography of prostate , uroflowmetry and post-void residual urine volume were performed at each visit . RESULTS A total of 115 patients were enrolled in the study and r and omized as 58 in the placebo group and 57 in the desmopressin group . Desmopressin significantly decreased nocturnal urine output and the number of nocturia episodes , and prolonged the first sleep period ( p < 0.01 ) . Compared to before treatment desmopressin gradually decreased serum sodium and induced statistically but not clinical ly significant hyponatremia after 12 months of treatment . No serious systemic complications were found during medication . CONCLUSIONS Low dose oral desmopressin is an effective and well tolerated treatment for nocturnal polyuria in the lower urinary tract symptoms of patients with benign prostatic hyperplasia . Long-term desmopressin therapy gradually decreases serum sodium and it might induce hyponatremia even in patients without initial hyponatremia . For long-term desmopressin administration serum sodium should be assessed carefully , at least at 1 week after treatment OBJECTIVE Evaluation of safety and efficacy of desmopressin/tolterodine combination therapy in women . METHODS This double-blind , r and omized , 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 ) . RESULTS 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 © scores were comparable . In post-hoc analysis , NP patients showed a benefit with combination versus monotherapy for nocturnal void volume ( P = 0.034 ) and time to first nocturnal void ( P = 0.045 ) , and a non-significant improvement in NI Diary © scores . Safety profile was comparable between treatments . A single transient event of asymptomatic clinical ly significant hyponatremia in combination group resolved subsequently . CONCLUSION 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 , prospect i ve validation studies of combination therapy are warranted in mixed NP/OAB population , based on this favorable proof-of-concept finding AIMS 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 . METHODS This was a 4-week , r and omized , double-blind study comparing 10 , 25 , 50 , or 100 µg desmopressin versus placebo in adults with defined nocturia . RESULTS 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 clinical ly 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 clinical ly significant risk of hyponatraemia . Each void reduced/hour of sleep gained was associated with significant improvements in QoL. CONCLUSIONS Desmopressin orally disintegrating tablet is an effective and well-tolerated treatment for patients with nocturia . Further exploration of the lower dose range is warranted OBJECTIVES To assess whether the synthetic vasopressin analogue desmopressin [ 1-desamino 8-D-arginine vasopressin ] is efficacious and safe in the management of nocturia + /- enuresis in patients with multiple sclerosis . PATIENTS AND METHODS Twenty-two women and 11 men , under 65 years of age , with clinical ly definite multiple sclerosis and nocturnal frequency + /- enuresis were entered into the study . A two week placebo run-in , to establish normal voiding patterns , followed by a double-blind , placebo-controlled , cross-over study of 20 micrograms intranasal desmopressin at night-time was carried out . RESULTS Desmopressin caused a significant decrease in nocturnal urinary frequency , nocturnal urinary volume and the percentage of total daily urine passed at night . There was no significant fall in plasma sodium with desmopressin although there were two cases of asymptomatic hyponatraemia . CONCLUSION Desmopressin is an efficacious and safe treatment for nocturia + /- enuresis in patients with multiple sclerosis To evaluate the decrease in nocturnal diuresis , nocturnal polyuria and the safety of oral desmopressin in elderly subjects with nocturia PURPOSE To our knowledge we report the first long-term use of desmopressin for nocturia .  Patients previously responding to desmopressin in short-term studies were enrolled in this long-term open label study . MATERIAL S AND METHODS Patients received treatment for 10 or 12 months with the optimal desmopressin dose ( 0.1 , 0.2 or 0.4 mg orally at bedtime ) . Patients were followed a further month without treatment . Of the patients completing the short-term study 132 males ( 92 % ) and 117 females ( 83 % ) were recruited , and 95 ( 72 % ) and 87 ( 75 % ) , respectively , completed long-term treatment . RESULTS The mean number of nocturnal voids was decreased in males and females throughout the study ( 1.3 to 1.6 and 1.2 to 1.3 ) compared with baseline ( 3.1 and 2.9 , respectively ) . After followup the number of voids increased after treatment cessation . From baseline to 12 months the mean duration of the first sleep period gradually increased in males ( 157 to 288 minutes ) and females ( 142 to 310 minutes ) . After followup the mean duration of the first sleep period decreased , confirming that it was a treatment related benefit . Desmopressin was well tolerated with few males ( 14 % ) or females ( 10 % ) withdrawing due to adverse events . Most adverse events were mild ( 44 % ) or moderate ( 44 % ) in severity . Four males experienced serious drug related adverse events , namely dizziness in 1 , cardiac failure , headache and vomiting in 2 , and chest pain and hypertension in 1 . A female experienced 4 serious drug related adverse events , that is hyponatremia , headache , nausea and vertigo . Two patients had clinical ly significant hyponatremia . CONCLUSIONS This long-term study shows that desmopressin is a generally well tolerated and effective treatment for nocturia
The analysis revealed that desmopressin might significantly decrease the frequency of nocturnal voids , nocturnal urine volume and nocturnal diuresis , potentially result ing 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 .
Conclusions Administered desmopressin was an effective and well-tolerated treatment for nocturia
Purpose The purpose of this analysis was to evaluate the efficacy and safety of desmopressin for the treatment of nocturia .