Benign Prostatic Hyperplasia
Conditions
Keywords
Lower urinary tract symptoms, benign prostatic hyperplasia
Brief summary
The purpose of this study is to confirm in a larger population in Europe the effectiveness and safety observed with silodosin in previous clinical trials.
Detailed description
The objective of the study is to confirm in a larger and less selected population (real life conditions) the positive risk-benefit balance observed with silodosin in double-blind, randomised clinical trials. The following aspects will be evaluated: * the effects on lower urinary tract symptoms (LUTS), by means of the International Prostate Symptoms Score (IPSS) questionnaire * the effect on the most frequent and bothersome symptoms, by means of International Continence Society (ICS)-male questionnaire * the effects on Quality of Life (QoL) due to urinary symptoms * the safety profile * the adherence to therapy * the patient satisfaction with treatment The effectiveness and safety of the drug will be investigated also in different subgroups of subjects according to age, severity of the disease, concomitant disease and medications.
Interventions
DRUGSilodosin
8 mg daily for 24 weeks
Sponsors
RECORDATI GROUP
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of Benign Prostatic Hyperplasia (BPH) by the urologist; * Male subjects aged 60 years or older; * IPSS total score equal or more than 12 at Visit 1 (Screening) and 2 (Baseline); * Able to comply with protocol procedures; * Written informed consent obtained before beginning any investigational procedures.
Exclusion criteria
* Hypersensitivity to the active substance or to any of the excipients; * Patients for whom cataract surgery is scheduled; * History of orthostatic hypotension or syncope; * Moderate or severe renal impairment (CLCR \<50 ml/min, as estimated by the Cockcroft Gault formula); * Severe hepatic impairment; * Concomitant use of other α-adrenoreceptor antagonists or natural/herbal products known to have an effect on LUTS (e.g. saw palmetto - serenoa serrulate/repens) . Patients already on treatment with those drugs may be enrolled after a 4 week wash-out period before Visit 2 (baseline); * Concomitant use with potent cytochrome P450 3A4 inhibitors, such as ketoconazole, itraconazole or ritonavir (possible pharmacokinetic interaction); * Prostate cancer; * History of prostate or bladder neck surgery, including transurethral prostatectomy, TUNA, laser or other minimally invasive therapy; * Active urinary tract infection; * Acute or recurrent prostatitis (more than 3 times in the last year); * History of neurological disease that may affect bladder function; * Unstable cardiovascular or cerebrovascular disease (including acute myocardial infarction, unstable angina pectoris, by-pass, percutaneous transluminal coronary angioplasty, congestive heart failure class III-IV, stroke, transient ischemic attack and episodes of cardiac arrhythmia requiring treatment in the last 6 months); * History or current evidence of drug or alcohol abuse within the last 12 months; * Participation in a study involving the administration of an investigational compound within the past 30 days; * Any other condition which, in the investigator's judgement, renders the subject unable to complete the study or increases the risk to the subject or which prevents optimal participation in achieving the objectives of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of the study is to evaluate the effects of silodosin on LUTS in terms of IPSS response rate (decrease from baseline ≥ 25% in the IPSS total score) | 6 months o treatment |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in IPSS total score | 4, 12, 24 weeks of treatment |
Other
| Measure | Time frame |
|---|---|
| Percentage of subjects improving each symptom of the ICS (International Continence Society) male questionnaire as compared to baseline; to evaluate the effect of silodosin on the most frequent and bothersome symptoms | 6 months of treatment |
Countries
Italy
Outcome results
None listed