Clinical trial NCT00941343: Benign Prostatic Hyperplasia in Taiwan
Official title: Sexuality and Management of Benign Prostatic Hyperplasia With Alfuzosin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Diseases
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-07-17
Enrollment: 362
Sex: MALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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


Eligibility 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.

Primary outcomes:
measure: Male Sexual Health Questionnaire Ejaculation score (MSHQ)
timeFrame: At week 24
Secondary outcomes:
measure: MSHQ Ejaculation score
timeFrame: At week 14, 12 and 24
measure: International Prostate Symptom Score (I-PSS) including quality of life index
timeFrame: At week 1, 4, 12 and 24
measure: Systolic and diastolic blood pressure
timeFrame: At week 1, 4, 12 and 24
measure: Heart rate
timeFrame: At week 1, 4, 12 and 24
measure: Prostate Specific Antigen
timeFrame: At week 24
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: Sharon Chang
role: STUDY_DIRECTOR
References: