Study to Evaluate the Effect of ALNA® (Tamsulosin) on the Primary Symptoms of Benign Prostatic Hyperplasia

Overview

The aims of this observational study are to identify the primary BPH symptoms responsible for the patients to consult a urologic practice, resulting in the prescription of ALNA®, to assess the clincial efficacy on an improved occupational performance of the patients being still employed. Additionally to obtain relevant information for the 5-year report of experience with this product according to the requirements in § 49, para 6 of the German Medicines Act.

Full Title of Study: “Effect of ALNA® (Tamsulosin) on the Primary Symptoms of BPH (Benign Prostatic Hyperplasia) Syndrome”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2001

Interventions

  • Drug: ALNA®

Arms, Groups and Cohorts

  • Patient with symptomatic of benign prostatic hyperplasia

Clinical Trial Outcome Measures

Primary Measures

  • Change in obstructive BPH symptoms
    • Time Frame: up to 12 weeks
  • Change in irritative BPH symptoms
    • Time Frame: up to 12 weeks

Secondary Measures

  • Change in Residual Urine volume
    • Time Frame: up to 12 weeks
  • Number of patients with adverse events
    • Time Frame: up to 12 weeks
  • Assessment of the number of days on sick leave
    • Time Frame: up to 12 weeks
  • Global assessment of efficacy by investigator on a 4-point scale
    • Time Frame: after 12 weeks
  • Change in Quality-of-Life Index
    • Time Frame: up to 12 weeks
  • Global assessment of tolerability by investigator on a 4-point scale
    • Time Frame: after 12 weeks
  • Changes in urinary flow rate
    • Time Frame: up to 12 weeks

Participating in This Clinical Trial

Inclusion Criteria

  • Patients suffering from symptomatic benign prostatic hyperplasia (BPH) symptoms and receiving ALNA® treatment are to be included in the observation according to the prescribing information

Exclusion Criteria

No exclusion criteria is defined, prescribing information is to be considered

Gender Eligibility: Male

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Boehringer Ingelheim
  • Provider of Information About this Clinical Study
    • Sponsor

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