Nocturia
Conditions
Brief summary
Observation of safety and efficacy of Minirin Melt® in adult patients with nocturia
Interventions
DRUGDesmopressin
60μg or 120μg once daily at bedtime
Sponsors
Ferring Pharmaceuticals
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Adult aged between 19 and 65 years * Patients having nocturia * Decision made to prescribe Minirin Melt according to prescription information * Willingness and ability to provide written informed consent
Exclusion criteria
* When patients have habitual or psychogenic polydipsia (resulting in a urine production exceeding 40ml/kg/24hours) * When patients have a history of known or suspected cardiac insufficiency and other conditions requiring treatment with diuresis * When patients have moderate and severe renal insufficiency (creatinine clearance below 50ml/min) * When patients have known hyponatremia * When patients have secretion Syndrome of Inappropriate Antidiuretic Hormone Secretion (SIADH) * When patients have hypersensitivity to the active substances or to any of the excipients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in mean number of nocturnal voids | Baseline and treatment-related visits up to 3 months | Calculated by 72 hour frequency volume chart (FVC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction from baseline in the mean number of nocturnal voids | Baseline and treatment-related visits up to 3 months | Assessed as a (50% decrease) or reduction of nocturnal diuresis (\>20%) |
Countries
South Korea
Outcome results
None listed