Prostatic Hyperplasia
Conditions
Brief summary
Study to assess efficacy, tolerability and safety parameters of a one month ALNA® - treatment after switch from Terazosin-treatment
Interventions
DRUGALNA®
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Suffering from BPS symptoms * Preceding treating with Terazosin for at least one month * IPSS sum score \>= 8 points prior to treatment start with ALNA® or complaints due to BP reduction by Terazosin * Indication for a switch to treatment with ALNA® according to its Summary of Product Characteristics (SPC) for a minimum period of one month
Exclusion criteria
* Patients fulfilling one of the general or specific contraindications listed in the ALNA® SPC, particularly patients with known hypersensitivities against tamsulosin hydrochloride or any other ingredients of the product, orthostatic dysregulation or severe liver insufficiency could not be included in the Post Marketing Surveillance (PMS) study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in International Prostatic Symptom Score (IPSS) by means on patient questionnaire | Baseline, after 1 month |
| Change of Quality of Life (QoL) Index by means on patient questionnaire | Baseline, after 1 month |
| Global comparative assessment of Terazosin and ALNA® treatment by investigator on a 3 point-scale | after 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline in Pulse rate (bpm) | Baseline, after 1 month | — |
| Change in complications due to low blood pressure | Baseline, after 1 month | Patient is asked for complications (weakness, dizziness, nausea) |
| Change from Baseline in maximum urinary flow rate (Qmax) | Baseline, after 1 month | — |
| Global assessment of tolerability by investigator on 4-point scale | after 1 month | — |
| Global assessment with BPS- treatment by investigator on a 4-point scale | Baseline, after 1 month | Switch from Terazosin therapy to ALNA® |
| Global assessment of efficacy by investigator on 4-point scale | after 1 month | — |
| Change from Baseline in residual urinary volume | Baseline, after 1 month | — |
| Change from Baseline in blood pressure | Baseline, after 1 month | — |
Outcome results
None listed