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

Boehringer Ingelheim4,150 enrolled

Overview

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))

Study Type

OBSERVATIONAL

Enrollment

4,150

Conditions

Prostatic Hyperplasia

Interventions

TamsulosinDRUG

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Change in IPSS sum score

Time frame: Day 1, 2 months

Change in Quality-of-Life Index (QoL) rated on a 7-point scale

Time frame: Day 1, 2 months

Secondary Outcomes

Change in sexual satisfaction rated on a 4-point scale

Time frame: Day 1, 2 months

Change in maximum urinary flow rate (ml/sec)

Time frame: Day 1, 2 months

Change in residual urine volume (ml)

Time frame: Day 1, 2 months

Patient's global assessment of the preceding phytotherapy on a 3-point scale

Time frame: Day 1

Patient's global assessment of the therapy with ALNA® on a 3-point scale

Time frame: after 2 months

Efficacy assessment of the preceding phytotherapy by physician rated on 4-point scale

Time frame: Day 1

Efficacy assessment of the therapy with ALNA® by physician rated on 4-point scale

Time frame: after 2 months

Tolerability assessment of the preceding phytotherapy by physician rated on 4-point scale

Time frame: Day 1

Tolerability assessment of the therapy with ALNA® by physician rated on 4-point scale

Time frame: after 2 months

Data from ClinicalTrials.gov

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