Abstract
Purpose
To evaluate the efficacy of desmopressin on nocturia, quality of sleep (QoS), and health-related quality of life (HRQoL) in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) and nocturia due to nocturnal polyuria (NP) as the predominant symptom.
Methods
A German observational, multicenter, post-marketing surveillance study including men with LUTS/BPH and nocturia due to NP starting 3 months of desmopressin treatment.
Results
In total, 137 patients with a mean of 3.8 nocturnal voids (range 2–7) were included. Desmopressin significantly reduced the mean number of nocturnal voids by 53 %, mean IPSS nocturia question by 50 %, and the mean ratio of night/24-h urine volume by 39 % from baseline to endpoint. The hours of undisturbed sleep significantly increased by 74 %; 71 % of men reported about undisturbed sleep of ≥4 h at study end. Additionally, there was a significant reduction in the Leeds Sleep Evaluation Questionnaire score, indicating a clinically relevant QoS improvement. This was associated with an improved HRQoL, as shown by a significant improvement in both the mean IPSS-QoL question by 43 % and mean ICIQ-N nocturia problem question by 53 %. Concomitant alpha-blocker use had no effect on the efficacy of desmopressin. The incidence of adverse events was low (2.2 %). Hyponatremia was not observed in any patient. The majority of patients and physicians rated the efficacy and tolerability of desmopressin as good/very good.
Conclusions
Desmopressin is an effective and well-tolerated treatment for nocturia due to NP in patients with LUTS/BPH in daily practice under routine conditions.
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Acknowledgments
This study was supported by an unconditional educational grant of FERRING GmbH which had no influence on the content of this publication. The authors would like to thank Dr. Jörg Schnitker, Institute for Statistics, Bielefeld, Germany for biometrical evaluation of the study data and the participating physicians for including their patients into this study and careful data collection.
Conflict of interest
Richard Berges is a lecturer, advisor and/or study participant in the field of LUTS/BPH for Astellas, GlaxoSmithKline, Ferring, Lilly, Pfizer, and Recordati. Klaus Höfner is a lecturer, advisor and/or study participant in the field of LUTS/BPH for Astellas, GlaxoSmithKline, Ferring, and Lilly. Michael Gedamke is employee of Ferring Arzneimittel GmbH in Germany. Matthias Oelke is a lecturer, advisor and/or study participant in the field of LUTS/BPH for Apogepha, Astellas, Biocompatibles, GlaxoSmithKline, Ferring, Lilly, Mundipharma, Pfizer, and Recordati.
Ethical standard
Ethics committee approval (study number FE992026_CS33) and written informed consent were obtained from all study participants. The study was designed and performed according to the German GCP recommendations and the 1964 Declaration of Helsinki.
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Berges, R., Höfner, K., Gedamke, M. et al. Impact of desmopressin on nocturia due to nocturnal polyuria in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH). World J Urol 32, 1163–1170 (2014). https://doi.org/10.1007/s00345-014-1381-7
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DOI: https://doi.org/10.1007/s00345-014-1381-7