Comparative Trial to Investigate the Efficacy and Safety of Desmopressin for the Treatment of Nocturia in Adult Men

Inclusion criteria

• Has given written consent prior to any trial-related activity is performed
• Male sex, aged 20 years or older
• At least 2 nocturnal voids every night in a consecutive 3-day period as documented in the diary during the screening period
• Has given agreement about contraception during the trial

Exclusion criteria

• Suspicion of bladder outlet obstruction or a urine flow of less than 5 mL/s as confirmed by uroflowmetry after suspicion of bladder outlet obstruction
• A surgical treatment for bladder outlet obstruction or prostatic hyperplasia within the past 6 months
• Showing symptoms of any of the following diseases: Benign prostatic obstruction; Interstitial cystitis; Overactive bladder, defined as >6 daytime voids, ≥1 urgency episode, and ≥1 urge urinary incontinence episode per 24 hours as documented in the 3-day diary period; Severe stress urinary incontinence
• Chronic prostatitis/chronic pelvic pain syndrome
• Psychogenic or habitual polydipsia
• Urinary retention or a post void residual volume in excess of 150 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention
• Cancer
• A history of urologic malignancies or a history of cancer which has not been in remission for the last 5 years
• Genito-urinary tract pathology
• Neurogenic detrusor activity
• Suspicion or evidence of heart failure
• Uncontrolled hypertension
• Uncontrolled diabetes mellitus
• Hepatobiliary diseases: Aspartate aminotransferase >80 U/L or alanine aminotransferase >90 U/L; Total bilirubin >1.5 mg/dL
• Renal insufficiency: Serum creatinine level >1.09 mg/dL; Estimated glomerular filtration rate <50 mL/min
• Hyponatraemia: Serum sodium level <135 mEq/L
• Central or nephrogenic diabetes insipidus
• Syndrome of inappropriate antidiuretic hormone
• Obstructive sleep apnea
• Previous desmopressin treatment
• Treatment with another investigational product within the past 3 months
• Concomitant treatment with any prohibited medication
• Alcohol or substance abuse
• A job or lifestyle that may interfere with regular night-time sleep
• A mental condition, lack of decision-making ability, dementia, a speech handicap, or any other reason which, in the judgement of the investigator (sub-investigator), would impair the participation in the trial