rodynamic study to verify the effects of silodosin on benign outlet obstruction in patient with benign prostatic hyperplasia

Phase 1

• Conditions: Benign prostatic hyperplasia; MedDRA version: 20.0Level: PTClassification code 10004446Term: Benign prostatic hyperplasiaSystem Organ Class: 10038604 - Reproductive system and breast disorders; Therapeutic area: Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

• Registration Number: EUCTR2015-002277-38-IT
• Lead Sponsor: RECORDATI S.P.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2017-03-16
• Study Start: 2017-12-15
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Male
• Target Recruitment: 30

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

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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified