Efficacy of desmopressin in the treatment of nocturia: a double‐blind placebo‐controlled study in men

Abstract

Objective To investigate the efficacy and safety of oral desmopressin in the treatment of nocturia in men. Patients and methods Men aged o18 years with verified nocturia (otwo voids/night) and nocturnal urine production greater than their maximum functional bladder capacity were recruited. A 3-week dosetitration phase established the optimum desmopressin dose (0.1, 0.2 or 0.4 mg). After a 1-week 'washout' period, patients who responded in the dose-titration period were randomized to receive the optimal dose of desmopressin or placebo in a double-blind design for 3 weeks. Results In all, 151 patients entered the double-blind period (86 treated with desmopressin, 65 with placebo). In the desmopressin group 28 (34%) patients and in the placebo group two (3%) patients (P<0.001) had fewer than half the number of nocturnal voids relative to baseline; the mean number of nocturnal voids decreased from 3.0 to 1.7 and from 3.2 to 2.7, respectively, reflecting a mean decrease of 43% and 12% (P<0.001). The mean duration of the first sleep period increased by 59% (from 2.7 to 4.5 h) in the desmopressin group, compared with an increase of 21% (from 2.5 to 2.9 h) in the placebo group (P<0.001). The mean nocturnal diuresis decreased by 36% (from 1.5 to 0.9 mL/min) in the desmopressin group and by 6% (from 1.7 to 1.5 mL/min) in the placebo group (P<0.001). The mean ratio of night/24-h urine volume decreased by 23% and 1% (P<0.001), and the mean ratio of night/day urine volume decreased by 27% and increased by 3% (P<0.001) for the desmopressin and placebo groups, respectively. In the double-blind treatment period, similar numbers of patients had adverse events; 15 (17%) patients in the desmopressin and 16 (25%) patients in the placebo group. Most adverse events were mild. Serum sodium levels were <130 mmol/L in 10 (4%) patients and this occurred during dose-titration. Conclusions Orally administered desmopressin is an effective and well-tolerated treatment for nocturia in men.

Desmopressin treatment in nocturia; an analysis of risk factors for hyponatremia

“…Serum sodium concentration was measured before screening, after each period in dose titration, after washout (except in the mixed gender study) and after the double-blind period. Patients who experienced a serum sodium concentration below 125 mmol/L were to be withdrawn from the study (Lose et al, 2003;Mattiasson et al, 2002;van Kerrebroeck et al, 2002).…”

“…Oral desmopressin, a vasopressin analogue, has shown efficacy in treatment of nocturia (the complaint that the individual has to wake at night one or more times to void (van Kerrebrock et al, 2002)) due to nocturnal polyuria (Lose et al, 2003;Mattiasson et al, 2002). The safety profile of desmopressin treatment in diabetes insipidus and nocturnal enuresis is well established (Drincic and Robertson, 1999;Glazener and Evans) and the only potentially serious adverse effect, hyponatremia, is a rare occurrence (<1/10 000).…”

“…The incidence of hyponatremia reported in nocturia has been significantly higher, with 12-22% of patients experiencing one or more episodes of serum sodium concentration below normal range (Lose et al, 2003;Lose et al, 2004;Mattiasson et al, 2002;Rembratt et al, 2003). Serum sodium concentration has been assessed in many clinical trials involving desmopressin, but rarely as frequently as in the large nocturia trials published by Mattiasson et al and Lose et al Consequently, it is expected that these trials unearth a higher frequency of non-symptomatic low serum sodium concentration.…”

Antidiuretic hormone in elderly male patients with severe nocturia: a circadian study

“…Oral desmopressin has been used to treat adult nocturia by decreasing nocturnal urine production [5,6]. In our experience nocturia of once or twice per night can be tolerated by most elderly people and can be treated by conventional medication in some patients.…”

Diagnosis and management of the overactive bladder syndrome in women

“…Desmopressin is effective in reducing the number of nocturnal voids. 30 Patients should be closely monitored as it can cause fl uid retention and hyponatraemia. It is not suitable for patients over the age of 65 years or those with renal impairment and cardiovascular disease.…”