Interstitial cystitis/Bladder Pain Syndrome is characterized by pain at the urinary bladder area, frequency and nocturia. According to the ICS definition, nocturia is the complaint that an individual has to awaken at night one or more times to void urine. Nocturia has a negative impact on quality of life, affecting both morbidity and mortality. It’s known that unfragmented sleep, 7 to 8 hours for most adults, is necessary for maintenance of physical, mental, and emotional well-being. Hence, our aim is a unfragmented sleep (7-8 hours) in patients with interstitial cystitis [1]. Melatonin can be promising medicine for that, because it's induce the sleep and has analgesic activity as well. Main problem of melatonin administration is a short time of its action.
After oral administration, plasma concentration peak arises within 60 minutes. A bioavailability study in four male healthy volunteers showed a plasma melatonin peak varying between 2 and 395 nmol/L and an elimination half-life of 47± 3 min (mean ± SD) after oral administration of a 500-µg dose [2]. Thus, for 8 hours unfragmented sleep we need slow-release melatonin. We've developed hydrogel-based slow-release melatonin. Aim of this study is evaluation of the efficacy this melatonin for nocturia treatment.

21 female patients with BPS participated in the study. Mean age was 42.6 + 6.9. All of them filled voiding diary (3 times) before the study. Two weeks before the trial participants stopped to take all medicines. All patients have taken 10 mg/10 ml hydrogel-based slow-release melatonin 2 hours before go to bed. Hydrogel is made of pectine and hyaluronic acid with preliminary dissolved melatonin. It’s releases melatonin gradually over 8-10 hours mimicking the body’s natural patterns of melatonin secretion.  The course of treatment lasted 30 days. All participants filled voiding diary 28, 29, 30 days of the study. No side effects have been observed.

According voiding diaries, nocturia before treatment was 5.1 + 1.45, after treatment became 1.33 + 0.97. This is significant difference. Most patients also noticed that bladder pain diminished as well.

Nocturia significantly diminished after the treatment with 10 mg of melatonin (slow-release hydrogel). Perhaps, higher dose of melatonin can be more effective, but we have to confirm it with another trial.

Treatment of nocturia in patients with bladder pain syndrome by slow-release hydrogel-based melatonin is a promising therapeutic option, but we need RCT. Hydrogel with melatonin can be a good treatment option for the bladder pain. The analgetic efficacy of melatonin in animal experiment with hot water tail flick test has started with 30 mg/kg of the rat’s weight [3]. The effect was dose-dependent. Thus, a gradual increase of the dose should be considered. The hydrogel-based slow-release melatonin allows to choose the dose.

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