Kosin Med J.  2020 Dec;35(2):101-113. 10.7180/kmj.2020.35.2.101.

Therapeutic Effects of Prolonged Release Melatonin (Circadin^® ) in Patients with Overactive Bladder and Chronic Insomnia in More Than 55 Years Old

• Park MJ
• Seo SY
• Park HJ
• Park JH
• Lim MY
• Park NC

• KMID: 2510271
• DOI: http://doi.org/10.7180/kmj.2020.35.2.101

Abstract

Objectives
Bladder storage symptoms including nocturia is the most common cause of sleep disturbance in all age groups. Sleep disturbance is also a main cause of nocturia so that sleep recovery can clinically improve nocturia. Melatonin has main action to induce sleep and additional effects of smooth muscle relaxation, free radical scavenging, anti-inflammation, et cetera. This study was evaluated the improvement of sleep quality after administrating prolonged-release melatonin in elderly patients with overactive bladder and chronic insomnia.
Methods
This clinical trial was performed with a randomized single open study. Thirty-seven patients with overactive bladder and chronic insomnia were initially enrolled in this study. After 4 or 12 weeks treating with 2 mg of prolongedrelease melatonin, clinical outcomes were evaluated with OABSS, IPSS, PSQI and WHO 5 well-being index.
Results
Of the 37 patients, 34 (91.9%) were included in the ITT group and 26 (76.5%) in the PP group. In the primary outcome of PP group, significant improvements were observed in total OABSS and nocturia frequencies at 12 weeks, respectively. Secondary outcome measurement including in voiding, storage symptoms, and total IPSS scores showed the improvement at 4 and 12 weeks and in total and sleep quality PSQI scores at 12 weeks, and in quality of life scores of the WHO 5 well-being index at 12 weeks. Only one (3.8%) adverse event was observed.
Conclusions
These results suggest clearly that prolonged-release melatonin in elderly patients with overactive bladder and chronic insomnia has the potential to control concomitant voiding and sleep difficulty.

Keyword

Insomnia; Melatonin; Nocturia; Overactive Bladder

Figure

• 

  Fig. 1 Study design and flow of Circadin® clinical trial study

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  Fig. 2 Changes of total score of overactive bladder symptom score (OABSS) and nocturia frequency (A) Total OABSS, (B) The nocturia frequency, Values are presented as mean ± standard deviation. *P > 0.05 vs baseline, ** P < 0.01 vs baseline, *** P < 0.001 vs baseline

• 

  Fig. 3 Change in mean total IPSS, voiding and storage symptom, total PSQI, and sleep quality (A) Total IPSS Score, (B) Voiding Symptoms, (C) Storage Symptoms, (D) Total PSQI Score, (E) Quality of Sleep * P > 0.05 vs baseline, ** P < 0.01 vs baseline, *** P < 0.001 vs baseline. Values are presented as mean ± standard deviation.

• 

  Fig. 4 Changes of quality of life by WHO 5 well-being index Values are presented as mean ± standard deviation.* P < 0.001 vs baseline

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  Fig. 5 Physiologic actions of melatonin on bladder

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