Investigation of the Superiority Effect of Orally Disintegrating Desmopressin Tablets to Placebo in Terms of Night Voids Reduction in Nocturia Adult Male Patients

Exclusion Criteria

• •Evidence of severe daytime voiding dysfunction defined as: Urge urinary incontinence (more than 1 episode/day in the 3-day diary period), Urgency (more than 1 episode/day in the 3-day diary period), Frequency (more than 8 daytime voids/day in the 3-day diary period)
• •Interstitial Cystitis
• •Chronic prostatitis/chronic pelvic pain syndrome
• •Suspicion of bladder outlet obstruction (BOO) or a urine flow of less than 5 mL/s as confirmed by uroflowmetry performed after suspicion of BOO
• •Surgical treatment, including transurethral resection, for BOO or benign prostatic hyperplasia within the past 6 months
• •Urinary retention or a post void residual volume in excess of 250 mL as confirmed by bladder ultrasound performed after suspicion of urinary retention
• •Habitual or psychogenic fluid intake resulting in a urine production exceeding 40 mL/kg/24 hours
• •Central or nephrogenic diabetes insipidus.
• •Syndrome of inappropriate anti-diuretic hormone.
• •Current or a history of urologic malignancies e.g. urothelium, prostate, or kidney cancer
• •Genitourinary tract pathology e.g. infection or stone in the bladder and urethra causing symptoms
• •Neurogenic detrusor activity (detrusor overactivity)
• •Suspicion or evidence of cardiac failure
• •Uncontrolled hypertension
• •Uncontrolled diabetes mellitus
• •Hyponatraemia: Serum sodium level must be within normal limits
• •Renal insufficiency: Serum creatinine must be within normal limits and estimated glomerular filtration rate must be more than or equal to 50 mL/min
• •Hepatic and/or biliary diseases: Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) levels must not be more than twice the upper limit of normal range. Total bilirubin level must not be more than 1.5 mg/dL
• •History of obstructive sleep apnea
• •Previous desmopressin treatment for nocturia
• •Treatment with another investigational product within 3 months prior to screening
• •Concomitant treatment with any prohibited medication, i.e. loop diuretics (furosemide, torsemide, ethacrynic acid) and any other investigational drug
• •Known alcohol or substance abuse
• •Work or lifestyle that may interfere with regular nighttime sleep e.g. shift workers
• •Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, or language barrier that, in the judgment of the investigator, would impair participation in the trial