Clinical trial NCT01757769: Effectiveness and Safety of Silodosin in the Treatment of Benign Prostatic Hyperplasia
Official title: Effectiveness and Safety of Silodosin in the Treatment of LUTS in Patients With Benign Prostatic Hyperplasia: a European Phase IV Clinical Study. The Silodosin in Real-life Evaluation Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Benign Prostatic Hyperplasia
Keywords: Lower urinary tract symptoms
benign prostatic hyperplasia
Lead sponsor: RECORDATI GROUP
Sponsor class: INDUSTRY
First posted: 2012-12-31
Enrollment: 1036
Sex: MALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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)
timeFrame: 6 months o treatment
Secondary outcomes:
measure: Change from baseline in IPSS total score
timeFrame: 4, 12, 24 weeks of treatment
Other outcomes:
measure: 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
timeFrame: 6 months of treatment
Locations:
city: Milan
country: Italy
facility: Vita e Salute University, Department of Urology, Istituto Scientifico Ospedale San Raffaele
Study officials:
affiliation: Urology Department, Royal Hallamshire Hospital, University of Sheffield, Glossop Road, Sheffield, S10 2JF, UK
name: Christopher R Chapple, MD
role: STUDY_CHAIR
References:
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