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• W2023731702 abstract "No AccessJournal of UrologyAdult Urology1 Sep 2013Efficacy and Safety of Low Dose Desmopressin Orally Disintegrating Tablet in Women with Nocturia: Results of a Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study Peter K. Sand, Roger R. Dmochowski, Jyotsna Reddy, and Egbert A. van der Meulen Peter K. SandPeter K. Sand NorthShore University HealthSystem, Evanston, Illinois Financial interest and/or other relationship with Allergan, Astellas, Ferring, Pfizer, Tena and Merck. More articles by this author , Roger R. DmochowskiRoger R. Dmochowski Department of Urology, Vanderbilt University, Nashville, Tennessee Financial interest and/or other relationship with Merck, Ferring, Johnson & Johnson and Allergan. More articles by this author , Jyotsna ReddyJyotsna Reddy Reproductive Health and Urology, Ferring International Pharmascience Center, Parsippany, New Jersey Financial interest and/or other relationship with Ferring Pharmaceuticals. More articles by this author , and Egbert A. van der MeulenEgbert A. van der Meulen Global Biometrics, Ferring International Pharmascience Center, Copenhagen, Denmark Financial interest and/or other relationship with Ferring Pharmaceuticals. More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2013.02.037AboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract Purpose: Previous studies suggest a lower dose of desmopressin orally disintegrating tablet may be effective in females compared to males with nocturia. We confirm the efficacy and safety of 25 μg desmopressin orally disintegrating tablet compared to placebo in female patients. Materials and Methods: In this 3-month, randomized, double-blind, parallel group study 25 μg desmopressin once daily was compared to placebo in women with nocturia (2 or more nocturnal voids). The co-primary efficacy end points were change from baseline in mean number of nocturnal voids and proportion of patients achieving at least a 33% reduction from baseline in the mean number of nocturnal voids (33% responders). Results: The full analysis set comprised 261 patients (age range 19 to 87 years). Desmopressin significantly reduced the mean number of nocturnal voids and increased the odds of a 33% or greater response compared to placebo during 3 months, assessed by longitudinal analysis (−0.22, p = 0.028 and OR 1.85, p = 0.006, respectively). Desmopressin increased the mean time to first nocturnal void by 49 minutes compared to placebo at 3 months (p = 0.003). The response to desmopressin was seen by week 1 of treatment and was sustained throughout the trial. Significant increases in health related quality of life and sleep quality were observed compared to placebo. Desmopressin was well tolerated. Serum sodium levels remained greater than 125 mmol/L throughout the trial and 3 transient decreases to less than 130 mmol/L were recorded. Conclusions: At a dose of 25 μg, desmopressin orally disintegrating tablet is an effective and well tolerated treatment for women with nocturia. Treatment provides rapid and sustained improvement in nocturia and quality of life. References 1 : The standardisation of terminology in nocturia: report from the Standardisation Sub-committee of the International Continence Society. Neurourol Urodyn2002; 21: 179. Google Scholar 2 : An International Urogynecological Association (IUGA)/International Continence Society (ICS) joint report on the terminology for female pelvic floor dysfunction. Int Urogynecol J2010; 21: 5. Google Scholar 3 : The prevalence and causes of nocturia. J Urol2010; 184: 440. Link, Google Scholar 4 : Nocturia and quality of life: results from the Boston Area Community Health survey. Eur Urol2012; 61: 78. 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Google Scholar © 2013 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetailsCited byErickson D (2018) What's in a Name?Journal of Urology, VOL. 191, NO. 1, (7-8), Online publication date: 1-Jan-2014.Ebell M, Radke T and Gardner J (2018) A Systematic Review of the Efficacy and Safety of Desmopressin for Nocturia in AdultsJournal of Urology, VOL. 192, NO. 3, (829-835), Online publication date: 1-Sep-2014.Clemens J (2018) Waking up to NocturiaJournal of Urology, VOL. 190, NO. 3, (838-839), Online publication date: 1-Sep-2013. Volume 190Issue 3September 2013Page: 958-964Supplementary Materials Advertisement Copyright & Permissions© 2013 by American Urological Association Education and Research, Inc.Keywordsnocturiaquality of lifeplacebosdeamino arginine vasopressinAcknowledgmentsMedical writing and editorial assistance provided by Dr. Kerry af Forselles, ApotheCom ScopeMedical Ltd, funded by Ferring Pharmaceuticals.MetricsAuthor Information Peter K. Sand NorthShore University HealthSystem, Evanston, Illinois Financial interest and/or other relationship with Allergan, Astellas, Ferring, Pfizer, Tena and Merck. More articles by this author Roger R. Dmochowski Department of Urology, Vanderbilt University, Nashville, Tennessee Financial interest and/or other relationship with Merck, Ferring, Johnson & Johnson and Allergan. More articles by this author Jyotsna Reddy Reproductive Health and Urology, Ferring International Pharmascience Center, Parsippany, New Jersey Financial interest and/or other relationship with Ferring Pharmaceuticals. More articles by this author Egbert A. van der Meulen Global Biometrics, Ferring International Pharmascience Center, Copenhagen, Denmark Financial interest and/or other relationship with Ferring Pharmaceuticals. More articles by this author Expand All Advertisement PDF downloadLoading ..." @default.
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