Prostatic Hyperplasia
Conditions
Brief summary
Study to assess efficacy, tolerability and safety parameters of a three month ALNA®OCAS® -treatment with special respect to nocturia
Interventions
DRUGALNA®OCAS®
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Indication for treatment with ALNA®OCAS® according to the prescribing information for a minimum period of three months
Exclusion criteria
* Patients fulfilling one of the general or specific contraindications listed in the ALNA®OCAS® Summary of Product Characteristics (SPC), particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency could not be included in the Post Marketing Study (PMS) study
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 | after 3 months |
| Number of patients with adverse events | up to 3 months |
Outcome results
None listed