SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin

Sanofi

Status and phase

Completed

Phase 4

Conditions

Prostatic Hyperplasia

Treatments

Drug: Alfuzosin

Study type

Interventional

Funder types

Industry

Identifiers

ALFUS_L_01667

Details and patient eligibility

About

Primary Objective:

To assess the sexual function improvement from baseline to the end of treatment (Week 24 or premature withdrawal (PW)) with XATRAL 10mg OD.

Secondary Objective:

To evaluate the association between Lower Urinary Tract Symptoms (LUTS) severity and sexual disorders,
To compare the improvement in sexual function, urinary symptoms and Quality of Life among the different regions,
To correlate MSHQ (Male Sexual Health Questionnaire) and IIEF-5 (the 5-Item version of the International Index of Erectile Function),
To assess the onset of action of XATRAL 10mg OD,
To assess the peak flow rate improvement (Qmax),
To assess the safety and the tolerability of XATRAL 10mg OD.

Enrollment

431 patients

Sex

Male

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH),
Patients with an I-PSS total score ≥ 8,
Patients sexually active

Exclusion criteria

Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant threatening-life 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.
Patients having received 5α-reductase inhibitors or LUTS related phytotherapy within 6 months prior to inclusion, or α1-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.