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) receiveddesmopressin (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 randomly 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.
RCT Entities:
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 randomly 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.
Authors: Casey G Kowalik; Joshua A Cohn; Sophia Delpe; W Stuart Reynolds; Melissa R Kaufman; Doug F Milam; Alan J Wein; Roger R Dmochowski Journal: Rev Urol Date: 2018
Authors: Kari A O Tikkinen; Anssi Auvinen; Theodore M Johnson; Jeffrey P Weiss; Tapani Keränen; Aila Tiitinen; Olli Polo; Markku Partinen; Teuvo L J Tammela Journal: Am J Epidemiol Date: 2009-06-10 Impact factor: 4.897