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

Boehringer Ingelheim

Status: Completed

Conditions: Prostatic Hyperplasia

Treatments: Drug: Tamsulosin

Study type: Observational

Funder types: Industry

Identifiers

NCT02244320

527.38

Details and patient eligibility

About

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))

Enrollment: 4,150 patients

Sex: Male

Volunteers: No Healthy Volunteers

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

Trial design

4,150 participants in 1 patient group

functional BPH

Description:

patients with functional BPH who switched from phytotherapy to ALNA®

Treatment:

Drug: Tamsulosin