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#344 - Multicenter randomized controlled trial of life style measures alone versus life style measures plus ramelteon for nocturia
K. Yoshimura, H. Ito, H. Okuno, S. Ishitoya, H. Onishi, K. Nishizawa, A. Terai, Y. Shimizu, N. Ito, A. Sengiku, K. Ogura, O. Ogawa
By Donald Bliwise
Yoshimura et al presented results from a RCT comparing life style interventions for nocturia with a drug targeting sleep, rather than bladder or renal physiology. The drug under study, ramelteon, is a prescription melatonin receptor (M1/M2) agonist, which has indications both in Japan and the US for poor sleep. Noteworthy about this trial is that there have been very few studies attempting to effect nocturia as an outcome by manipulating sleep per se. The study was designed to include 100 subjects randomized equally to both groups, however, the trial was stopped after an interim analysis showed no benefit ascribed to ramelteon over life style interventions.
Commentary: Although it is tempting to dismiss the role of a medication to improve sleep as a treatment for nocturia on this basis of these interim results, ramelteon is known to not be a particularly potent hypnotic and, in fact, that arm of the study did not result in statistically significant improvement in sleep, as measured with the PSQI. Thus, the original goal could never be addressed since the drug targeting sleep did not have its desired effect.