Prostatic Hyperplasia
Conditions
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.
Interventions
DRUGALNA®
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in obstructive BPH symptoms | up to 12 weeks |
| Change in irritative BPH symptoms | up to 12 weeks |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Outcome results
None listed