Objective: To evaluate the effect of melatonin on nocturia.

Background: Nocturia is one of the commonest non motor symptoms in Parkinsons’ disease (PD), and has a highly significant negative impact on quality of life, affecting both the patients and their carers. It has been demonstrated that nocturia could be due to increased production of urine at night due to impaired circadian rhythm. We aimed to improve circadian regulation with melatonin with the aim to control symptoms and disability related to nocturia.

Methods: This was an open label clinical trial of sustained-release Melatonin 2mg once daily for 6 weeks in patients with PD. We included over 18 year old patients reporting nocturia based on to NMSQuest item 9 –“Getting up regularly at night to pass urine” two or more times at night. We excluded patients with cognitive decline (MOCA score <26), REM sleep behaviour disorder, significant retention on bladder scan, or bladder outflow obstruction on urodynamics. Assessments included urinary symptoms and quality of life questionnaires, bladder and sleep diaries Data of awakenings and quality of sleep was recorded using wrist accelerometer worn two weeks prior to starting melatonin, and during treatment. The primary analysis of “bother related to nocturia” compared the endpoints before (week 0) and whilst on treatment (week 6). The quality of life was assessed before and after treatment using EQ5D.

Results: The study is still ongoing 17 patients have included in the study, 10 have completed the study. A more detailed analysis with results will soon be available, but in the interim analysis, the mean age of the patients included was 68.4 years (SD =4.9). The average duration of PD was 7.2 years (SD=6.7). The drug was well tolerated in the 10 patients who completed the study. The bother related to nocturia averaged 6.9 before and 5.3 with treatment. The average EQ5D scores were 65.5 before and increased to 71 during treatment at 6 weeks. Seven patients continued on the medication after completion of trial as they found it helpful.

Conclusions: While we wait for more detailed results, it appears that melatonin was well tolerated and 70% continued the medication to help with nocturia after the treatment period. Melatonin may have a useful role in managing nocturia in patients with PD, but more detailed analysis of the data and larger studies will be needed to confirm this.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/single-centre-open-label-exploratory-phase-iib-pilot-study-of-exogenous-oral-melatonin-for-the-treatment-of-nocturia-in-adults-with-parkinsons-disease/