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Impact of desmopressin on nocturia due to nocturnal polyuria in men with lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH)

From: R. Berges, K. Höfner, M. Gedamke and M. Oelke.

World Journal of Urology, Volume 32, Issue 5, pages 1163-1170, October 2014

Editor’s comments:
This multicenter study was conducted in 69 centers across Germany and included 137 men affected by LUTS/BPH with nocturia due to nocturnal polyuria (NP), and who were treated with desmopressin. 

Included patients exhibiting ≥2 nocturia episodes/night due to NP, and who started desmopressin treatment in a 3-month period between January 2009 and March 2010. Desmopressin 0.1 mg before going to bed was the first dose proposed to patients; which could be increased or decreased by request of the patient after one week, to a minimum of 0.05 mg or a maximum dose of 0.4 mg/day. Efficacy of treatment was evaluated at baseline and after 12 weeks by means of a voiding diary and the following questionnaires: IPSS, IPSS-Q7and ICIQ-N and Leeds Sleep Evaluation Questionnaire (LSEQ). Safety evaluation was performed on any patient-reported, treatment-related, adverse effects and serum sodium concentration. 12 weeks after treatment it was observed that desmopressin statistically and clinically improved nocturia in patients. In particular,  nocturia significantly reduced from 3.8 to 1.7 voids/night (-53%), and 87% of patients reported a reduction of nocturia to ≥1 void/night. The ratio night/24-h urine volume decreased from 35.5 to 21.5% (−39%, p < 0.0001) and mean hours of undisturbed sleep increased from 138 minutes to 240 minutes (+74 %, p < 0.0001). With regards to treatment safety, 1.5% of patients complained of diarrhea and 0.7% of them presented gynecomasta: two effects which induced discontinuation of the treatment. Serum sodium concentration remained stable throughout the study and hyponatremia  (<130 µmol/l) was not observed in any of the patients.

The study demonstrates that desmopressin is effective and well tolerated by patients, with fewer side effects in respect of treatment-related compared to placebo-controlled studies previously published. The results in this study also show that it is possible to treat nocturia in men affected by LUTS/BPH when nocturnal polyuria, as an aetiology of nocturia, is adequately investigated and treated.

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. © 2014 Springer-Verlag Berlin Heidelberg.

Author keywords:
Benign prostatic hyperplasia; Desmopressin; Lower urinary tract symptoms; Nocturia; Nocturnal polyuria; Observational study; Quality of life