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

NCT02244268 | Completed

• 1 other identifier: 527.20
• Study Type: observational
• Target: 3,629
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (2)

• Change in obstructive BPH symptoms

  up to 12 weeks

• Change in irritative BPH symptoms

  up to 12 weeks

Secondary Outcomes (7)

• Change in Residual Urine volume

  up to 12 weeks

• Number of patients with adverse events

  up to 12 weeks

• Assessment of the number of days on sick leave

  up to 12 weeks

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

  after 12 weeks

• Change in Quality-of-Life Index

  up to 12 weeks

Study Arms (1)

Patient with symptomatic of benign prostatic hyperplasia

Drug: ALNA®

Interventions

ALNA® DRUG

Also known as: tamsulosin

Patient with symptomatic of benign prostatic hyperplasia

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients suffering from symptomatic benign prostatic hyperplasia (BPH) syndrome recruited in urological practices

You may qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 18, 2014
• First Posted: September 19, 2014
• Study Start: October 1, 2000
• Primary Completion: December 1, 2001
• Last Updated: September 19, 2014

Record last verified: 2014-09