SAMBA: Sexuality And Management of Benign Prostatic Hyperplasia With Alfuzosin
Study Details
Study Description
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:
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To evaluate the association between Lower Urinary Tract Symptoms (LUTS) severity and sexual disorders,
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To compare the improvement in sexual function, urinary symptoms and Quality of Life among the different regions,
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To correlate MSHQ (Male Sexual Health Questionnaire) and IIEF-5 (the 5-Item version of the International Index of Erectile Function),
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To assess the onset of action of XATRAL 10mg OD,
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To assess the peak flow rate improvement (Qmax),
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To assess the safety and the tolerability of XATRAL 10mg OD.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 4 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 1
|
Drug: Alfuzosin
Alfuzosin 10mg Once Daily for 24 weeks
|
Outcome Measures
Primary Outcome Measures
- Mean change from baseline to the end of treatment in the Male Sexual Health Questionnaire(MSHQ) for sexual function. [24 weeks]
- 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) [24 weeks]
Secondary Outcome Measures
- - 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 [24 weeks]
- - 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) [24 weeks]
- -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 [24 weeks]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Patients suffering from moderate to severe lower urinary tract symptoms (LUTS), suggestive of symptomatic Benign Prostatic Hyperplasia (BPH),
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Patients with an I-PSS total score ≥ 8,
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Patients sexually active
Exclusion Criteria:
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Known history of hepatic or severe renal insufficiency, unstable angina pectoris, concomitant threatening-life condition.
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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.
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Active urinary tract infection or prostatitis, neuropathic bladder, a diagnosed prostate cancer.
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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.
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History of postural hypotension or syncope.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sanofi-Aventis | Bogota | Colombia | ||
| 2 | Sanofi-Aventis | Quito | Ecuador | ||
| 3 | Sanofi-Aventis | Guatemala City | Guatemala | ||
| 4 | Sanofi-Aventis | Mexico | Mexico |
Sponsors and Collaborators
- Sanofi
Investigators
- Study Director: Jesus Ruiz, MD, Sanofi
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ALFUS_L_01667