Study to Evaluate the Effect of ALNA® (Tamsulosin) on the Primary Symptoms of Benign Prostatic Hyperplasia
Completed
- Conditions
- Prostatic Hyperplasia
- Interventions
- Drug: ALNA®
- Registration Number
- NCT02244268
- Lead Sponsor
- Boehringer Ingelheim
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Male
- Target Recruitment
- 3629
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
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Exclusion Criteria
No exclusion criteria is defined, prescribing information is to be considered
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patient with symptomatic of benign prostatic hyperplasia ALNA® -
- Primary Outcome Measures
Name Time Method Change in obstructive BPH symptoms up to 12 weeks Change in irritative BPH symptoms up to 12 weeks
- Secondary Outcome Measures
Name Time Method 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 Global assessment of tolerability by investigator on a 4-point scale after 12 weeks Changes in urinary flow rate up to 12 weeks