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

Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL 10mg OD), Open, 24-week Study.

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.

Study Overview

• Status: Completed
• Conditions: Prostatic Hyperplasia
• Intervention / Treatment: Drug: Alfuzosin

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Phase 4

Contacts and Locations

Study Locations

• Thailand
  • Bangkok, Thailand
    • Sanofi-Aventis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Alfuzosin for 24 weeks	Drug: Alfuzosin; One tablet of 10mg once daily at the end of evening meal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
MSHQ Ejaculation score	End of treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
MSHQ Ejaculation score	After 4 weeks of treatment
MSHQ Ejaculation score	After 12 weeks of treatment
Acute Urinary Retention	End of treatment
Correlation between MSHQ and IPSS	End of treatment
I-PSS total score	After 1 week of treatment
I-PSS total score	After 4 weeks of treatment
I-PSS total score	After 12 weeks of treatment
I-PSS total score	End of treatment
IPSS total score decrease = 3 points	End of treatment
IPSS: filling sub-score	After 1 week of treatment
IPSS: filling sub-score	After 4 weeks of treatment
IPSS: filling sub-score	After 12 weeks of treatment
IPSS: filling sub-score	End of treatment
IPSS: nocturia symptoms sub-score	After 1 week of treatment
IPSS: nocturia symptoms sub-score	After 4 weeks of treatment
IPSS: nocturia symptoms sub-score	After 12 weeks of treatment
IPSS: nocturia symptoms sub-score	End of treatment
IPSS: voiding sub-score	After 1 week of treatment
IPSS: voiding sub-score	After 4 weeks of treatment
IPSS: voiding sub-score	After 12 weeks of treatment
IPSS: voiding sub-score	End of treatment
MSHQ ejaculation: erection sub-score	After 4 weeks of treatment
MSHQ ejaculation: erection sub-score	After 12 weeks of treatment
MSHQ ejaculation: erection sub-score	End of treatment
MSHQ ejaculation: satisfaction sub-score	After 4 weeks of treatment
MSHQ ejaculation: satisfaction sub-score	After 12 weeks of treatment
MSHQ ejaculation: satisfaction sub-score	End of treatment
Quality of Life	After 4 weeks of treatment
Quality of Life	After 12 weeks of treatment
Quality of Life	End of treatment

Collaborators and Investigators

• Sponsor: Sanofi
• Investigators: Study Director: Natesumroeng Taweeporn, Sanofi

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: November 17, 2006
• First Submitted That Met QC Criteria: November 17, 2006
• First Posted (Estimate): November 20, 2006

Study Record Updates

• Last Update Posted (Estimate): September 15, 2009
• Last Update Submitted That Met QC Criteria: September 14, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Alfuzosin
• Other Study ID Numbers: ALFUS_L_01241