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

Completed

• Conditions: Prostatic Hyperplasia
• Interventions: Drug: Tamsulosin

• Registration Number: NCT02244320
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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))

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2003-05
• Status Verified: 2014-09
• Study First Submitted: 2014-09-18
• Study First Submitted QC: 2014-09-18
• Last Update Submitted: 2014-09-18
• Study First Posted: 2014-09-19
• Last Update Posted: 2014-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 4150

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
functional BPH	Tamsulosin	patients with functional BPH who switched from phytotherapy to ALNA®

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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