Observational Study in Patients With Functional Benign Prostatic Hyperplasia Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)

Study Overview
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Brief Summary
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The objective of the observational study were to investigate the switch from phytotherapy to ALNA® after at least 4 weeks of phytotherapy and still presented with a symptom sum score of ≥ 8 points (International Prostate Symptom Score (IPSS))

Official Title
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Observational Study in Patients With Functional BPH (Benign Prostatic Hyperplasia) Symptoms Who Switched From Phytotherapy to ALNA® (Tamsulosin)

Conditions
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Prostatic Hyperplasia

Intervention / Treatment
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* Drug: Tamsulosin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients suffering from BPH symptoms Preceding treatment with a phytotherapeutic for at least 4 weeks IPSS sum score ≥ 8 points prior to treatment start with ALNA® Indication for a switch to treatment with ALNA® for a minimum period of 2 months Exclusion Criteria: Patients fulfilling one of the general or specific contraindications listed in the ALNA® Summary of Product Characteristic, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredient of the product, orthostatic dysregulation or severe liver insufficiency Patients receiving ALNA® within the 4 weeks prior to the start of the present observational study
Sexes Eligible for Study
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Male

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 |
| --- | --- |
| functional BPH<br>patients with functional BPH who switched from phytotherapy to ALNA® | Drug: Tamsulosin<br> <br> * Other names: ALNA®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in IPSS sum score |  | Day 1, 2 months | 
| Change in Quality-of-Life Index (QoL) rated on a 7-point scale |  | Day 1, 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sexual satisfaction rated on a 4-point scale |  | Day 1, 2 months | 
| Change in maximum urinary flow rate (ml/sec) |  | Day 1, 2 months | 
| Change in residual urine volume (ml) |  | Day 1, 2 months | 
| Patient's global assessment of the preceding phytotherapy on a 3-point scale |  | Day 1 | 
| Patient's global assessment of the therapy with ALNA® on a 3-point scale |  | after 2 months | 
| Efficacy assessment of the preceding phytotherapy by physician rated on 4-point scale |  | Day 1 | 
| Efficacy assessment of the therapy with ALNA® by physician rated on 4-point scale |  | after 2 months | 
| Tolerability assessment of the preceding phytotherapy by physician rated on 4-point scale |  | Day 1 | 
| Tolerability assessment of the therapy with ALNA® by physician rated on 4-point scale |  | after 2 months | 
| Number of patients with adverse drug reactions (ADR) |  | up to 2 months |