Alfuzosin XL Lower Urinary Tract Symptoms Efficacy and Sexuality Study (ALEX-XL)

Sanofi

Status and phase

Completed

Phase 4

Conditions

Prostatic Diseases

Treatments

Drug: Alfuzosin

Study type

Interventional

Funder types

Industry

Identifiers

NCT00575913

L_8935

Details and patient eligibility

About

To assess, under daily practice conditions, the safety profile and the efficacy of a new formulation of alfuzosin administered once daily (Xatral XL) in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).

Enrollment

118 patients

Sex

Male

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Ambulatory patients suffering from lower urinary tract symptoms suggestive of BPH.

Exclusion criteria

Patients requiring BPH surgery immediately or within the 12 following months:
- Acute renal obstruction
- Chronic renal obstruction
- Chronic renal failure from BPH
- Bladder stone
- Recurrent urinary tract infection
- Other bladder pathology such as cancer of the bladder, bladder bidiverticulum (big size)
- Hematuria from BPH
Patients whose urinary symptoms are satisfactorily controlled on other BPH medication ( alpha-blockers or 5 alpha-reductase)
Patients previously not improved by an alpha1-blocker treatment
Known hypersensitivity to alfuzosin
History of postural hypotension or syncope
Combination with other alpha1-blockers
Hepatic enzyme (SGOT or/and SGPT ) > 1.5 Upper Normal Limit
Unstable angina pectoris
Severe concomitant condition threatening life.
Patients who had failed treatment with finasteride (Proscar)
Patients with neuropathic bladder.
Patients with history of previous surgery for BPH
Patients with high risk for prostate cancer based on the clinical judgement of the investigator