Benign Prostatic Hyperplasia in Taiwan

• Status: Completed
• Trial end date: 2008-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

Primary Objective:

• To assess the sexual function of Benign Prostatic Hyperplasia patients

Secondary Objective:

• To evaluate the association between Lower Urinary Tract Symptoms severity and sexual disorders

• To compare the sexual function, urinary symptoms and Quality of Life of Benign Prostatic Hyperplasia patients on XATRAL 10mg OD among the different regions

• To correlate the Male Sexual Health Questionnaire(MSHQ) and 5-item version of the International Index of Erectile Function (IIEF-5)

• To assess the onset of action of XATRAL 10mg OD

• To assess the peak urinary flow rate

• To assess the safety and the tolerability of XATRAL 10mg OD

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Alfuzosin

Criteria

Inclusion criteria

• Male suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH)

• Sexually active

• Sexual attempts at least once per month

Exclusion criteria

• Known history of hepatic or severe renal insufficiency

• unstable angina pectoris

• concomitant threatening-life condition

• Previous transurethral resection of the prostate (TURP)

• Had a minimally invasive procedure within 6 months prior to inclusion

• Planned prostate surgery or minimally invasive procedure during the whole study period

• Active urinary tract infection or acute prostatitis

• Neuropathic bladder

• Diagnosed prostate cancer

• Patients having received 5-reductase inhibitors or Lower Urinary Tract Symptoms (LUTS) related phytotherapy or anti-muscarinics drug for OAB or 1-blockers within 1 month prior to inclusion

• Patients receiving any treatment for erectile dysfunction within 1 month prior to inclusion

• History of postural hypotension or syncope

• Known hypersensitivity to alfuzosin

• Patients illiterate or unable to understand or to complete the questionnaires

• Patients having participated in any clinical study in the past month

• Prostate Specific Antigen (PSA)> age specific Prostate Specific Antigen value, without using prostate biopsy to rule out prostate cancer

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