Clinical trial NCT00486785: SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin
Official title: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin 10mg Once Daily (XATRAL OD 10mg), Open, 24-week Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Prostatic Hyperplasia
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-06-15
Enrollment: 431
Sex: MALE
Minimum age (years): 50
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mean change from baseline to the end of treatment in the Male Sexual Health Questionnaire(MSHQ) for sexual function.
timeFrame: 24 weeks
measure: Evaluation of adverse events, vital signs (blood pressure and heart rate), PSA (Prostate-specific antigen; mandatory at baseline and optional at the end of treatment) and serum creatinine assessment (optional at baseline and at the end of treatment)
timeFrame: 24 weeks
Secondary outcomes:
measure: - Mean change from baseline to 4, 12, and 24 weeks of treatment in MSHQ in the ejaculation score - Mean change from baseline to 4, 12 and 24 weeks of treatment in MSHQ ejaculation questions, in the erection questions and sexual activity and desire
timeFrame: 24 weeks
measure: - Mean change from baseline to week 1 in I-PSS total score and sub-scores (objective onset of action) - Onset of action based on patient perception (questionnaire at Week 1)
timeFrame: 24 weeks
measure: -Mean change from baseline to 4,12 and 24 weeks of treatment in the I-PSS total score and in the Quality of Life -QOL Mean change from baseline to 4, 12 and 24 weeks of treatment in the I-PSS total score and in the Quality of Life
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Bogota
country: Colombia
facility: Sanofi-Aventis
city: Quito
country: Ecuador
facility: Sanofi-Aventis
city: Guatemala City
country: Guatemala
facility: Sanofi-Aventis
city: Mexico
country: Mexico
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Jesus Ruiz, MD
role: STUDY_DIRECTOR
References: