The Impact of Alna® Ocas® on Nocturia in Patients With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (LUTS/BPH)

Boehringer Ingelheim5,775 enrolled

Overview

Study to assess efficacy, tolerability and safety parameters of a three month ALNA®OCAS® -treatment with special respect to nocturia

Study Type

OBSERVATIONAL

Enrollment

5,775

Conditions

Prostatic Hyperplasia

Interventions

ALNA®OCAS®DRUG

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change from Baseline in International Prostatic Symptom Score (IPSS) by means of a patient questionnaire

Time frame: Baseline, after 3 months

Change from Baseline in Nocturia quality of life by means of a patient questionnaire

Time frame: Baseline, after 3 months

Secondary Outcomes

Change from Baseline in Maximum urinary flow rate (Qmax)

Time frame: Baseline, after 3 months

Change from Baseline in residual urine volume

Time frame: Baseline, after 3 months

Assessment of tolerability by investigator on 4-point scale

Time frame: after 3 months

Number of patients with adverse events

Time frame: up to 3 months

Data from ClinicalTrials.gov

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