Clinical trial NCT00401661: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin
Official title: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL 10mg OD), Open, 24-week Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostatic Hyperplasia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2006-11-20
Enrollment: 110
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: MSHQ Ejaculation score
timeFrame: End of treatment
Secondary outcomes:
measure: MSHQ Ejaculation score
timeFrame: After 4 weeks of treatment
measure: MSHQ Ejaculation score
timeFrame: After 12 weeks of treatment
measure: Acute Urinary Retention
timeFrame: End of treatment
measure: Correlation between MSHQ and IPSS
timeFrame: End of treatment
measure: I-PSS total score
timeFrame: After 1 week of treatment
measure: I-PSS total score
timeFrame: After 4 weeks of treatment
measure: I-PSS total score
timeFrame: After 12 weeks of treatment
measure: I-PSS total score
timeFrame: End of treatment
measure: IPSS total score decrease = 3 points
timeFrame: End of treatment
measure: IPSS: filling sub-score
timeFrame: After 1 week of treatment
measure: IPSS: filling sub-score
timeFrame: After 4 weeks of treatment
measure: IPSS: filling sub-score
timeFrame: After 12 weeks of treatment
measure: IPSS: filling sub-score
timeFrame: End of treatment
measure: IPSS: nocturia symptoms sub-score
timeFrame: After 1 week of treatment
measure: IPSS: nocturia symptoms sub-score
timeFrame: After 4 weeks of treatment
measure: IPSS: nocturia symptoms sub-score
timeFrame: After 12 weeks of treatment
measure: IPSS: nocturia symptoms sub-score
timeFrame: End of treatment
measure: IPSS: voiding sub-score
timeFrame: After 1 week of treatment
measure: IPSS: voiding sub-score
timeFrame: After 4 weeks of treatment
measure: IPSS: voiding sub-score
timeFrame: After 12 weeks of treatment
measure: IPSS: voiding sub-score
timeFrame: End of treatment
measure: MSHQ ejaculation: erection sub-score
timeFrame: After 4 weeks of treatment
measure: MSHQ ejaculation: erection sub-score
timeFrame: After 12 weeks of treatment
measure: MSHQ ejaculation: erection sub-score
timeFrame: End of treatment
measure: MSHQ ejaculation: satisfaction sub-score
timeFrame: After 4 weeks of treatment
measure: MSHQ ejaculation: satisfaction sub-score
timeFrame: After 12 weeks of treatment
measure: MSHQ ejaculation: satisfaction sub-score
timeFrame: End of treatment
measure: Quality of Life
timeFrame: After 4 weeks of treatment
measure: Quality of Life
timeFrame: After 12 weeks of treatment
measure: Quality of Life
timeFrame: End of treatment
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Natesumroeng Taweeporn
role: STUDY_DIRECTOR
References: