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OpenTrials
Completed

NCT Number: NCT02244268

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

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.

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Key information

Conditions

Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Urogenital Diseases

Sex eligibility

Male

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ALNA®

Drug

Other names: tamsulosin

Primary outcomes

  1. Change in obstructive BPH symptoms

    Time frame: up to 12 weeks

  2. Change in irritative BPH symptoms

    Time frame: up to 12 weeks

Secondary outcomes

  1. Change in Residual Urine volume

    Time frame: up to 12 weeks

  2. Number of patients with adverse events

    Time frame: up to 12 weeks

  3. Assessment of the number of days on sick leave

    Time frame: up to 12 weeks

  4. Global assessment of efficacy by investigator on a 4-point scale

    Time frame: after 12 weeks

  5. Change in Quality-of-Life Index

    Time frame: up to 12 weeks

  6. Global assessment of tolerability by investigator on a 4-point scale

    Time frame: after 12 weeks

  7. Changes in urinary flow rate

    Time frame: up to 12 weeks

Sponsors and collaborators

Lead sponsor

Boehringer Ingelheim

Industry

Registry information

Official study title

Effect of ALNA® (Tamsulosin) on the Primary Symptoms of BPH (Benign Prostatic Hyperplasia) Syndrome

Important dates

Study start
2000
Primary completion
2001
First posted
Sep 19, 2014
Registry last updated
Sep 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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