Table 2.
Inclusion and exclusion criteria of the DISTINCT Study
| Inclusion criteria | Exclusion criteria |
|---|---|
| 1. Nocturnal urinary frequency is 2 or more. | 1. Concentration of serum sodium is less than 135 mEq/L |
| 2. Nocturnal polyuria index is 0.33 or more. | 2. Habitual or psychogenic polydipsia |
| 3. FUSP is 2.5 h or less. | 3. Heart failure, the history of heart failure, or suspected heart failure |
| 4. Concentration of serum sodium is 135 mEq/L or more. | 4. Fluid retention that requires diuretic treatment, whether currently or in the patient’s medical history |
| 5. Creatinine clearance or eGFR is 50 mL/min/1.73m2 or more. | 5. Antidiuretic hormone incompatible secretion syndrome |
| 6. Patients with BPH or OAB are acceptable if the storage symptoms (urgency and daytime frequency) are well managed and stable for 3 months or more by any treatments or 6 months or more by 5-alpha reductase inhibitors. | 6. Moderate or severe renal failure (Creatinine clearance or eGFR < 50 mL/min/1.73m2) |
| 7. Hypersensitivity to desmopressin or the history, whether currently or in the patient’s medical history | |
| 8. Concomitant or scheduled administration of thiazides, thiazide-like diuretics, or loop diuretics | |
| 9. Concomitant or scheduled administration of corticosteroids | |
| 10. Cardiac pacemaker implantation | |
| 11. Judged to be inappropriate by the principal investigator or subinvestigators |
FUSP the first uninterrupted sleep period, BPH benign prostatic hyperplasia, OAB overactive bladder, eGFR estimate glomerular filtration rate