NOCDURNA PASS Study Using Registries in Denmark, Germany and Sweden

Study Overview
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Brief Summary
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A study using medical records to evaluate safety issues for the NOCDURNA drug using national register data from Denmark and Sweden, and a health care register covering parts of Germany.

Official Title
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Post-authorisation Safety Study of NOCDURNA for the Symptomatic Treatment of Nocturia Due to Idiopathic Nocturnal Polyuria: A Multi-country Cohort Study Using Secondary Data

Conditions
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Adverse Drug Event

Intervention / Treatment
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* Other: NOCDURNA Cohort
* Other: LUTS Cohort


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Usage of NOCDURNA recorded as dispensations from drugstores in adults or or usage of drugs for LUTS. Exclusion Criteria: Multiple dispensation of NOCDURNA on the same day or treatment with vasopressin 6 months before study start.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| NOCDURNA cohort<br> | Other: NOCDURNA Cohort<br>* Non intervention<br>|
| Lower urinary tract symptoms (LUTS) Cohort<br> | Other: LUTS Cohort<br>* Non intervention<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of symptomatic hyponatraemia | Symptomatic hyponatraemia was defined as a primary or secondary diagnosis of hyponatraemia. | Through study completion, typically 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence rate of hyponatraemia requiring hospital intensive care | Hyponatraemia requiring hospital intensive care was defined as a primary or secondary diagnosis of hyponatraemia recorded in an intensive care unit. | Through study completion, typically 2 months | 
| Incidence and severity of clinically significant hyponatraemia | Clinically significant hyponatraemia was defined as a serum sodium concentration of <130 mmol/L. Severity of hyponatraemia was categorized as mild hyponatraemia (serum sodium concentration: 130 to <135 mmol/L), moderate hyponatraemia (serum sodium concentration: >125 to <130 mmol/L) and severe hyponatraemia (serum sodium concentration: less than equal to [≤]125 mmol/L). | Through study completion, typically 2 months | 
| Rate of all-cause mortality | All-cause mortality was defined as death from any cause. | Through study completion, typically 2 months | 
| Incidence rate of major adverse cardiovascular events (MACE) | Major adverse cardiovascular events were defined as a record of myocardial infarction and stroke. Fatal and non-fatal events will be considered separately. | Through study completion, typically 2 months | 
| Incidence rate of major venous thromboembolic events (VTEs) | Venous thromboembolic events were defined as a record of a deep vein thrombosis, pulmonary embolism or portal vein thrombosis. Fatal and non-fatal events will be considered separately. | Through study completion, typically 2 months | 
| Incidence rate acute exacerbation of congestive heart failure | Acute exacerbation of congestive heart failure was defined as primary diagnosis of acute or acute-on-chronic heart failure from hospital inpatient care or the acute and emergency ward, or death from heart failure as the underlying or contributory cause. | Through study completion, typically 2 months | 
| Incidence of serious adverse events of MACE and VTE in Sweden |  | Through study completion, typically 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Nocturia, NOCDURNA, Post-authorisation Safety Study