Nocturia, defined by the U.S Food and Drug Administration (FDA) as the need to void two or more times per night, affects over 89 million adults in the U.S., While the condition is common, it is an understudied and often under-diagnosed urological disorder occurring in adults. The condition affects men and women almost equally across all age groups. Although it is more frequently diagnosed in older adults, nocturia is not a natural part of aging.
Currently, there is no FDA-approved drug indicated for the treatment of nocturia, even though the condition is the most common lower urinary tract symptom (LUTS). Nocturia is a leading reason for visits to urologists, and many patients also seek treatment for the condition from gynecologists, geriatric specialists, neurologists, sleep experts, endocrinologists and general practitioners, placing a large burden on the U.S. healthcare system.
 U.S. Food and Drug Administration. Need Relief From Overactive Bladder Symptoms? 2015 July. http://www.fda.gov/forconsumers/consumerupdates/ucm426099.htm
 Age Groups and Sex: 2000 data set: Census 2000 Summary File (SF1)
 Weiss JP, Blaivas JG, Bliwise DL, et al. The evaluation and treatment of nocturia: a consensus statement. BJU Int. 2011;108:6–21. http://www.ncbi.nlm.nih.gov/pubmed/21676145
 Bosch JL, Weiss JP. The prevalence and causes of nocturia. J Urol. 2010 Aug;184(2):440-6. doi: 10.1016/j.juro.2010.04.011.
 Miranda EP, Gomes CM, Torricelli FCM, de Bessa J Jr., de Castro JE, da Silva Ferreira BR, Scafuri AG, Bruschini H, Srougi M. Nocturia is the Lower Urinary Tract Symptom With Greatest Impact on Quality of Life of Men From a Community Setting. Int Neurourol J. 2014 June; 18(2): 86–90. Published online 2014 June 26. doi: 10.5213/inj.2014.18.2.86