Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin (SAMBA-Thailand)

Sanofi

Status and phase: Completed; Phase 4

Conditions: Prostatic Hyperplasia

Treatments: Drug: Alfuzosin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00401661

ALFUS_L_01241

Details and patient eligibility

About

Primary objective:

• End-point improvement from baseline in Male Sexual Health Questionnaire Ejaculation domain (MSHQ-EjD)in men with lower urinary tract symptoms (LUTS)suggestive of benign prostatic hyperplasia (BPH) treated for 6 months with XATRAL 10mg once daily OD.

Secondary objectives:

• MSHQ-EjD improvement by visit
• Improvement in International Prostate Symptom Score (IPSS) total score, voiding and filling subscores, nocturia and bother score at end-point and by visit
• Onset of action of XATRAL 10mg OD
• Tolerability of XATRAL 10mg OD including occurrence of acute urinary retention.

Enrollment: 110 patients

Sex: Male

Ages: 50+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients suffering from moderate to severe LUTS suggestive of BPH
• I-PSS total score ≥ 8
• Patients sexually active

Exclusion criteria

• Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant life-threatening condition
• Previous prostate surgery, minimally invasive procedure within 6 months prior to inclusion. Planned prostate biopsy, prostate surgery or minimally invasive procedure during the whole study period
• Active urinary tract infection or prostatitis, neuropathic bladder, a diagnosed prostate cancer
• Treatment with 5alpha-reductase inhibitors or phytotherapy within 6 months prior to inclusion, or alpha1-blockers within 30 days prior to inclusion
• Patients receiving any treatment for erectile dysfunction (i.e. phosphodiesterase-5 inhibitors) at inclusion
• History of postural hypotension or syncope
• Known hypersensitivity to alfuzosin

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 1 patient group

1

Experimental group

Description:

Alfuzosin for 24 weeks

Treatment:

Drug: Alfuzosin