Study Investigating the Impact Burden of Nocturia Using the Nocturia Impact Diary

Exclusion Criteria

• •1. Chronic prostatitis (males)/chronic pelvic pain syndrome (CPPS)
• •2. Suspicion of bladder outlet obstruction (BOO) or a urine flow of \< 5 mL/s as confirmed by uroflowmetry performed after suspicion of BOO
• •3. Surgical treatment, including transurethral resection, for BOO or benign prostatic hyperplasia (males) within the past six months
• •4. Urinary retention or a post void residual volume \> 150 mL for females and \> 250 mL for males as confirmed by bladder ultrasound performed after suspicion of urinary retention
• •5. Central or nephrogenic diabetes insipidus
• •6. Syndrome of inappropriate antidiuretic hormone
• •7. Current or a history of urologic malignancies e.g. bladder cancer
• •8. Genito-urinary tract pathology e.g. infection or stone in the bladder and urethra causing symptoms
• •9. Neurogenic detrusor activity (detrusor overactivity)
• •10. Suspicion or evidence of cardiac failure
• •11. Chronic prostatitis (males)/chronic pelvic pain syndrome (CPPS)
• •12. Uncontrolled hypertension
• •13. Uncontrolled diabetes mellitus
• •14. Hyponatraemia: serum sodium level must be within normal limits
• •15. Renal insufficiency: Serum creatinine must be within normal limits and estimated glomerular filtration rate must be ≥ 50 mL/min
• •16. 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 \> 1.5 mg/dL
• •17. History of obstructive sleep apnea
• •18. Treatment with another investigational product (except desmopressin) within three months prior to screening and throughout the study
• •19. Concomitant treatment with loop diuretics (furosemide, torsemide, ethacrynic acid)
• •20. Pregnancy, breastfeeding, or an intention of becoming pregnant during the period of the clinical study. Female subjects of reproductive age must have documentation of a reliable method of contraception. All pre-and perimenopausal female subjects have to perform pregnancy tests. Amenorrhea of \> 12 months duration based on the reported date of the last menstrual period is sufficient documentation of post-menopausal status and does not require a pregnancy test
• •21. Known alcohol or substance abuse
• •22. Work or lifestyle that may interfere with regular night-time sleep e.g. shiftworkers 23. Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity, or language barrier which, in the judgment of the Investigator, would impair participation in the study