Benign prostatic hyperplasia MedDRA version: 20.0 Level: PT Classification code 10004446 Term: Benign prostatic hyperplasia System Organ Class: 10038604 - Reproductive system and breast disorders
Conditions
Interventions
Trade Name: UROREC - 8 MG - CAPSULA RIGIDA - USO ORALE - BLISTER(PVC/PVDC/ALU) 10 CAPSULE
Product Name: UROREC
Pharmaceutical Form: Capsule, hard
Sponsors
RECORDATI S.P.A.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: Male subjects aged 50 years or older; Patients waiting to undergo surgical intervention for LUTS/BPH; No pharmacological treatment for LUTS/BPH in the last 4 weeks; Presence of moderate-severe LUTS, as assessed by an IPSS total score ? 13 at Visit 1 (Screening); Quality of life affected by LUTS, as assessed by a IPSS-QoL score = 3 at Visit 1 (Screening); Prostate volume of ? 30 ml, assessed by suprapubic ultrasound; Maximum urine flow rate (Qmax) = 15 mL/sec., with a minimum voided volume of ? 125 mL; Presence of obstruction in urodynamic study performed at Visit 2 (Baseline), according to Inetrnational Continence Society (ICS) nomogram, based on the Bladder Outlet Obstruction Index (BOOI) > 40; Agree not to use any other approved or experimental BPH or overactive bladder medication anytime during the study; Able to comply with protocol procedures; Written informed consent obtained before beginning any investigational procedures. Are the trial subjects under 18? no Number of subjects for this age range: 1 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: Hypersensitivity to the active substance or to any of the excipients; Absolute indication for surgery therapy (such as recurrent or refractory urinary retention, overflow incontinence, recurrent UTIs, bladder stones or diverticula, treatment resistant macroscopic haematuria due to BPH/BPE, or dilatation of the upper urinary tract due to BPO, with or without renal insufficiency) for which any delay in the intervention is not recommended; Neurological causes of detrusor overactivity (e.g. multiple sclerosis, Parkinson’s disease, diabetic neurophathy); Presence of active urinary tract infections; Presence or history of bladder calculi; Presence of prostate cancer. Subjects with a PSA > 10.0 ng/mL will be excluded. Subjects with a PSA between 4.0 and 10.0 should have prostate cancer ruled out to the satisfaction of the clinical Investigator with appropriate documentation of the physician’s assessment; Post-void residual urine volume > 300 mL, assessed by suprapubic ultrasound; Clinically significant cardiovascular and cerebrovascular disease within 6 months prior to screening, including myocardial infarction, unstable angina, significant ventricular arrhythmias, heart failure (NYHA classes III-IV), stroke, transient ischemic attack; Renal impairment (serum creatinine > 2.0 mg/dL); Hepatic impairment (GGT, AST or ALT > 3xULN); Patients for whom cataract surgery is scheduled; History of orthostatic hypotension or syncope; Participation in an investigational drug study within 30 days prior to the start of the study; Any other condition which, in the investigator's judgement, renders the subject unable to complete the study or which prevents optimal participation in achieving the objectives of the study; Prohibited concomitant medications: • a-adrenoceptor antagonists, 5-?-reductase inhibitors such as dutasteride and finasteride, natural/herbal products known to have an effect on LUTS (e.g. saw palmetto - serenoa serulata/repens), tadalafil 5 mg daily, anticholinergic agents, antidepressants, anti-anxiety agents during study participation. Note: occasional use of PDE-5 inhibitors for erectile dysfunction is allowed but not within 48 hours of any study visit. • Concomitant use with potent CYP3A4 inhibitors, such as ketoconazole, itraconazole or ritonavir (possible PK interaction).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to evaluate the effects of silodosin on the change from baseline in Bladder Outlet Obstruction Index (BOOI). ;Secondary Objective: Secondary objectives are to evaluate: the effects on LUTS and QoL due to urinary symptoms, as assessed by the International Prostate Symptoms Score (IPSS); the percentage of subjects considering their condition improved enough to spare or delay the surgical intervention for BPH; the effects on other urodynamic parameters; the categorical improvement from baseline in obstruction class (obstructed, equivocal, unobstructed) on the ICS BOOI nomogram; the effects on post-void residual volume, as assessed by ultrasound; the safety profile of the drug. ;Primary end point(s): Change from baseline in Bladder Outlet Obstruction Index (BOOI), calculated from the pressure-flow parameters detrusor pressure at maximum flow (pdetQmax) and maximum flow rate (Qmax), according to the following equation: BOOI= pdetQmax – (2x Qmax).;Timepoint(s) of evaluation of this end point: after 8 weeks of treatment with the study drug | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Change from baseline in the total International Prostate Symptoms Score (IPSS). Percentage of subjects completing the treatment period who answer “yes” to the question: “After the treatment with silosodin, is your condition improved enough to spare or delay the surgical intervention for BPH?”; Change from baseline in other urodynamic parameters: - Maximum flow rate (Qmax) - Max detrusor pressure (pdet.max), - Detrusor pressure at maximum flow (pdetQmax) - Volume at first desire to void (FD) - Maximum cystometric capacity (MCC) - Bladder compliance (MCC/Pves at MCC – Pves at baseline) - Percentage of patients showing detrusor overactivity (DO) - Amplitude of largest involuntary contraction - Volume at first involuntary contraction - Bladder Contraction Index (BCI). Categorical improvement from baseline in obstruction class (obstructed, equivocal, unobstructed) on the ICS BOOI nomogram. Post-void residual volume (PVR), by ultrasound. Change from baseline in IPSS storage and voiding subscores. Change from baseline in IPSS Q8 (QoL).;Timepoint(s) of evaluation of this end point: after 8 weeks of treatment with the study drug | — |
Countries
Italy
Contacts
Public ContactDirezione Medica
Recordati S.p.A.
Outcome results
None listed