Oral desmopressin for nocturnal polyuria in elderly subjects: a double-blind, placebo-controlled randomized exploratory study.

OBJECTIVE

To evaluate the decrease in nocturnal diuresis, nocturnal polyuria and the safety of oral desmopressin in elderly subjects with nocturia.

SUBJECTS AND

METHODS

After being identified using a population-based questionnaire, subjects were included in the study if they; (i) were healthy and free from medication with possible influence on the diuresis or voiding pattern; (ii) had an increased nocturnal frequency (>/=2 nocturnal voids/night, as reported before screening); (iii) had a nocturnal urinary output of >/=0.9 mL/min; (iv) completed and responded to an initial dose-titration study. Twelve men and five women (mean age 67.7 years, sd 4.6 years) met these criteria and were treated with oral desmopressin or placebo at bedtime for 2 weeks on each medication in a randomized, double-blind, crossover design.

RESULTS

Subjects treated with desmopressin had a significantly reduced nocturnal diuresis of 0.59 mL/min compared with those on placebo (95% confidence interval, CI, 0.33-0.85). The 24-h diuresis was unaffected by desmopressin treatment. Patients treated with desmopressin had fewer micturitions at night than had those on placebo (1.1 and 1.7, respectively; P<0.001; mean difference=0.59; 95% CI, 0.32-0.85). The reduction in nocturnal diuresis was dependent on the baseline level of night-time diuresis (r=0.886; r2=0.785; P<0.0001) and the nocturnal part of the baseline 24 h-diuresis (r=0.708; r2=0.502; P<0.001). After desmopressin treatment was withdrawn, diuresis returned to the levels before treatment. The time from falling asleep to first awakening was improved by 1.4 h in patients treated with desmopressin. There was no change in body weight or ankle circumference during desmopressin treatment. Overall, the treatment was well tolerated and no serious adverse events were observed.

CONCLUSION

Desmopressin was effective in reducing nocturnal diuresis and nocturnal voids in polyuric elderly subjects, with no significant adverse events or inconvenience to the patient. The length of uninterrupted sleep was also improved.