1953 TREATMENT OF NOCTURIA IN WOMEN: RESULTS OF A RANDOMIZED, CONTROLLED, DOUBLE-BLIND, 3-MONTH, PHASE III, SAFETY AND EFFICACY STUDY OF DESMOPRESSIN ORALLY DISINTEGRATING TABLET

Abstract

You have accessJournal of UrologyUrodynamics/Incontinence/Female Urology: Non-neurogenic Voiding Dysfunction1 Apr 20131953 TREATMENT OF NOCTURIA IN WOMEN: RESULTS OF A RANDOMIZED, CONTROLLED, DOUBLE-BLIND, 3-MONTH, PHASE III, SAFETY AND EFFICACY STUDY OF DESMOPRESSIN ORALLY DISINTEGRATING TABLET Roger R. Dmochowski, Peter K. Sand, Egbert A. van der Meulen, and Jens Peter Nørgaard Roger R. DmochowskiRoger R. Dmochowski Nashville, TN More articles by this author , Peter K. SandPeter K. Sand Evanston, IL More articles by this author , Egbert A. van der MeulenEgbert A. van der Meulen Copenhagen, Denmark More articles by this author , and Jens Peter NørgaardJens Peter Nørgaard Copenhagen, Denmark More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.2372AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Nocturia interrupts sleep and is associated with multiple negative outcomes, especially when occurring ≥2 times/night. Desmopressin is the only medication that specifically targets nocturnal polyuria, which is the most common cause of nocturia. The objective of this study was to confirm the optimal dose of an orally disintegrating tablet (ODT) formulation in women with nocturia. METHODS Randomized, controlled, double-blind, age-stratified, 3-month study at 39 centers, comparing 25 mcg desmopressin ODT vs. placebo in women with ≥2 voids/night and no evidence of severe daytime voiding dysfunction (e.g. >8 daytime voids). Endpoints/analyses were pre-defined and as per International Conference on Harmonisation (ICH) guidelines and FDA consultation. RESULTS 261 women (age range 19-87 years) with an average of ∼3 voids/night were included in the full analysis set. Baseline characteristics were comparable. 89% of randomized patients completed the study. 25 mcg desmopressin ODT: 1.Significantly reduced the mean number of nocturnal voids by -1.46 (treatment difference vs. placebo: -0.22; p = 0.028) and increased the odds of a ≥33% response vs. placebo by 85% (OR: 1.85; p = 0.006) during 3 months. The effect of desmopressin was rapid (week 1), sustained, and similar in those <65 and ≥65 years. 2.Significantly increased the mean time to first nocturnal void by +155 min (treatment difference vs. placebo: 49 min; p = 0.003) and reduced the nocturnal urine volume by 235 ml (difference: 83 ml; p = 0.003) at month 3. 3.Significantly improved health-related quality of life (N-QoL questionnaire; total and 2 sub-domain scores), sleep related visual analogue score for quality of sleep and feeling refreshed the next morning, and overall activity (Work Productivity and Activity Impairment questionnaire) at month 3. 4.Did not result in any serum sodium drops <125 mmol/L or treatment withdrawal due to hyponatremia. Overall, the adverse event profile was comparable to placebo. CONCLUSIONS The major new finding of this study is the confirmation of the efficacy of 25 mcg desmopressin orally disintegrating tablet for the treatment of nocturia in women of all ages combined with the absence of clinically significant reductions in sodium levels/hyponatremia. The finding of improved quality of life and sleep quality further supports the value of desmopressin. This study supports recommendations for future gender-specific desmopressin doses for the treatment of nocturia. © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 189Issue 4SApril 2013Page: e800 Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.MetricsAuthor Information Roger R. Dmochowski Nashville, TN More articles by this author Peter K. Sand Evanston, IL More articles by this author Egbert A. van der Meulen Copenhagen, Denmark More articles by this author Jens Peter Nørgaard Copenhagen, Denmark More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...