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Study to assess efficacy, tolerability and safety parameters of a three month ALNA®OCAS® -treatment with special respect to nocturia
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPH patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALNA®OCAS® | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in International Prostatic Symptom Score (IPSS) by means of a patient questionnaire | Baseline, after 3 months | |
| Change from Baseline in Nocturia quality of life by means of a patient questionnaire | Baseline, after 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Maximum urinary flow rate (Qmax) | Baseline, after 3 months | |
| Change from Baseline in residual urine volume | Baseline, after 3 months | |
| Assessment of tolerability by investigator on 4-point scale |
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Inclusion Criteria:
Exclusion Criteria:
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BPH patients who are indicated for treatment with ALNA®OCAS® with special respect to nocturia recruited at urologists
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| after 3 months |
| Number of patients with adverse events | up to 3 months |
| D052801 |
| Male Urogenital Diseases |