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Exploratory pilot study of exogenous sustained‐release melatonin on nocturia in Parkinson's disease
Author(s) -
Batla Amit,
Simeoni Sara,
Uchiyama Tomoyuki,
deMin Lorenzo,
Baldwin Joanne,
Melbourne Charles,
Islam Saiful,
Bhatia Kailash P.,
Pakzad Mahreen,
Eriksson Sofia,
Panicker Jalesh N.
Publication year - 2021
Publication title -
european journal of neurology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.881
H-Index - 124
eISSN - 1468-1331
pISSN - 1351-5101
DOI - 10.1111/ene.14774
Subject(s) - nocturia , medicine , melatonin , overactive bladder , international prostate symptom score , parkinson's disease , adverse effect , urology , disease , lower urinary tract symptoms , physical therapy , urinary system , prostate , alternative medicine , pathology , cancer
Nocturia is one of the commonest non‐motor symptoms in Parkinson's disease (PD). Nocturia has evolved from being understood as a symptom of urological disorders or neurogenic bladder dysfunction to being considered as a form of circadian dysregulation. Exogenous melatonin is known to help circadian function and can be an effective strategy for nocturia in PD. Methods In this open‐label, single‐site, exploratory, phase 2 pilot study, adults with PD and nocturia underwent assessments using standardized questionnaires, urodynamics studies and a bladder scan. This was followed by completion of a frequency volume chart (FVC) and 2‐week sleep diary. Sustained‐release melatonin 2 mg was then administered once‐nightly for 6 weeks. A repeat assessment using questionnaires, the FVC and sleep diary was performed whilst on treatment with melatonin. Companion or bed partners filled in sleep questionnaires to assess their sleep during the intervention. Results Twenty patients (12 males; mean age 68.2 [SD = 7.8] years; mean PD duration 8.0 [±5.5] years) with PD reporting nocturia were included. Administration of melatonin was associated with a significant reduction in the primary outcome bother related to nocturia measured using the International Consultation on Incontinence Questionnaire Nocturia (ICIQ‐N) ( p = 0.01), number of episodes of nocturia per night ( p = 0.013) and average urine volume voided at night ( p = 0.013). No serious adverse events were reported. No significant improvement was noted in bed partner sleep scores. Conclusions In this preliminary open‐label study, administration of sustained‐release melatonin 2 mg was found to be safe for clinical use and was associated with significant improvements in night‐time frequency and nocturnal voided volumes in PD patients.