Efficacy and Safety of Desmopressin Melt for the Treatment of Nocturia

Exclusion Criteria

• •Males:
• •1. Clinical suspicion of bladder outlet obstruction and/or urine flow \< 5 ml/s. If medical history and/or physical examination suggest bladder outlet obstruction, uroflowmetry should be performed to confirm the diagnosis
• •2. Surgical treatment for bladder outlet obstruction/benign prostatic hyperplasia performed within the past 6 months
• •Females:
• •3. Pregnancy. Females of reproductive age must have documentation of a reliable method of contraception.
• •4. Use of pessary for pelvic prolapse.
• •5. Unexplained pelvic mass.
• •Males and Females:
• •6. Clinical suspicion of urinary retention and/or post void residual volume \> 150 ml. If medical history and/or physical examination suggest urinary retention, bladder ultrasound or catheterization should be performed to confirm the diagnosis.
• •7. Current or past urologic malignancy (e.g., bladder cancer, prostate cancer).
• •8. Clinical evidence of current genitourinary tract pathology that could interfere with voiding.
• •9. History of neurogenic detrusor activity (previously known as detrusor hyperreflexia).
• •10. Suspicion or evidence of cardiac failure.
• •11. Uncontrolled hypertension.
• •12. Uncontrolled diabetes mellitus.
• •13. Renal insufficiency. Serum creatinine must be within normal limits and estimated glomerular filtration rate (eGFR) \>=60 mL/min.
• •14. Active hepatic and/or biliary disease. Aspartate transaminase (AST) or alanine transaminase (ALT) should not be \>2 times the upper limit of normal. Total bilirubin should not be \> 1.5 mg/dL.
• •15. Hyponatremia. Serum sodium level must be within normal limits
• •16. Syndrome of Inappropriate antidiuretic hormone secretion (SIADH).
• •17. Diabetes insipidus (urine output \> 40 ml/kg over 24 hours) as determined by the 3-day voiding diary.
• •18. Psychogenic or habitual polydipsia
• •19. Obstructive sleep apnea
• •Other
• •20. Known alcohol or substance abuse
• •21. Work or lifestyle potentially interfering with regular nighttime sleep (e.g., shift workers)
• •22. Previous desmopressin treatment for nocturia.
• •23. Any other medical condition, laboratory abnormality, psychiatric condition, mental incapacity or language barrier that, in the judgment of the investigator, could impair patient participation in the trial.
• •24. Use of loop diuretics (furosemide, torsemide, ethacrynic acid). Other classes of diuretics (thiazides, triamterene, chlorthalidone, amiloride, indapamide) were permitted, either as monotherapy or combination therapy. Subjects using a diuretic were to be encouraged to take it in the morning, if medically feasible.
• •25. Use of any other investigational drug within 30 days of screening.
• •Concomitant Medications
• •The following medications are permitted provided that the subject has been on a stable dose for the 3 months prior to the screening date (i.e. treatment has not been initiated or discontinued and there has been no change in dose):
• •Alpha-blockers: Cardura (doxazosin); Flomax (tamsulosin); Hytrin (terazosin); Uroxatral (alfuzosin)
• •5 alpha-reductase inhibitors: Avodart (dutasteride); Proscar (finasteride)
• •Antispasmodic, anticholinergic, antimuscarinic therapy for overactive bladder: Detrol, Detrol LA (tolterodine); Ditropan, Ditropan XL (oxybutynin); Enablex (darifenacin); Levsin(hyoscyamine); Oxytrol transdermal (oxybutynin); Sanctura (trospium); Vesicare (solifenacin)
• •Sedative/hypnotic medications for sleep disorders
• •Selective serotonin and mixed norepinephrine/serotonin reuptake inhibitors: Celexa (citalopram); Cymbalta (duloxetine); Effexor (venlafaxine); Lexapro (escitalopram); Paxil(paroxetine); Prozac (fluoxetine); Zoloft (sertraline)
• •Chronic use of nonsteroidal anti-inflammatory agents
• •Diabinese (chlorpropamide)
• •Carbamazepine (carbatrol/tegretol)
• •Amiodarone