The Impact of Alna® Ocas® on Nocturia in Patients With Lower Urinary Tract Symptoms Suggestive of Benign Prostatic Hyperplasia (LUTS/BPH)
Completed
- Conditions
- Prostatic Hyperplasia
- Interventions
- Drug: ALNA®OCAS®
- Registration Number
- NCT02245542
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Study to assess efficacy, tolerability and safety parameters of a three month ALNA®OCAS® -treatment with special respect to nocturia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 5775
Inclusion Criteria
- Indication for treatment with ALNA®OCAS® according to the prescribing information for a minimum period of three months
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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
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description BPH patients ALNA®OCAS® -
- Primary Outcome Measures
Name Time Method Change from Baseline in Nocturia quality of life by means of a patient questionnaire Baseline, after 3 months Change from Baseline in International Prostatic Symptom Score (IPSS) by means of a patient questionnaire Baseline, after 3 months
- Secondary Outcome Measures
Name Time Method Change from Baseline in residual urine volume Baseline, after 3 months Number of patients with adverse events up to 3 months Assessment of tolerability by investigator on 4-point scale after 3 months Change from Baseline in Maximum urinary flow rate (Qmax) Baseline, after 3 months