Prostatic Hyperplasia
Conditions
Brief summary
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.
Interventions
DRUGAlfuzosin
One tablet of 10mg once daily at the end of evening meal
Sponsors
Sanofi
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| MSHQ Ejaculation score | End of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Acute Urinary Retention | End of treatment |
| Correlation between MSHQ and IPSS | End of treatment |
| I-PSS total score | After 1 week of treatment |
| IPSS total score decrease = 3 points | End of treatment |
| IPSS: filling sub-score | After 1 week of treatment |
| MSHQ Ejaculation score | After 4 weeks of treatment |
| IPSS: voiding sub-score | After 1 week of treatment |
| MSHQ ejaculation: erection sub-score | After 4 weeks of treatment |
| MSHQ ejaculation: satisfaction sub-score | After 4 weeks of treatment |
| Quality of Life | After 4 weeks of treatment |
| IPSS: nocturia symptoms sub-score | After 1 week of treatment |
Countries
Thailand
Outcome results
None listed