Phase 4
Completed N=232
The Long Term Effects of Alfuzosin(Xatral XL) in Lower Urinary Tract Symptoms(LUTS)/BPH Patients
BPH
Source: ClinicalTrials.gov NCT00696761 ↗
Enrolled (actual)
232
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcomePrimary: Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment — 13.0; 12.0; 10.6; 13.4 score — p=<0.05
Summary
Benign prostatic hyperplasia (BPH) is a common condition among older men. The efficacy of α1-blockers for treating BPH has been well documented and they are recommended for the treatment of BPH by clinical guidelines.
It is not well known if a stratification based on the grade of BOO and bladder contractility has any predictive value for patients who are treated with an α1-selective blocking agent. In our study, we investigated possible differences in treatment outcome between patients with and without BOO, and with or without proper contractility who are treated with alfuzosin. So we will compare the quantified improvements 12 months after alfuzosin medication in LUTS/BPH patients by the grade of BOO and/or bladder contractility.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment |
13.0; 12.0; 10.6; 13.4 | <0.05 sig |
| PRIMARY Treatment Efficacy Was Analyzed by Validated Symptom Scores. |
8.3; 6.4; 6.4; 9.0 | <0.05 sig |
| SECONDARY Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum) |
8.2; 7.2; 9.7; 8.2 | — |
| SECONDARY Changes of Peak Flow Rates on Uroflowmetry |
14.3; 10.9; 16.8; 13.0 | — |
| SECONDARY Changes in Residual Urine Volumes |
51.6; 37; 29.3; 31.7 | — |
Eligibility Criteria
Inclusion Criteria
- Ambulatory males (≥50 years) suffering from LUTS suggestive of BPH
- Patients satisfying all of the following:
- Moderate to severe LUTS :
- international prostate symptom score (IPSS)≥ 8
- An enlarged prostate (≥25 mL)
- Decreased peak flow rate : Qmax ≤15 mL/s (volume voided ≥ 120 mL)
Exclusion Criteria
- Post voided residual urine ≥ 200 mL
- Patients performing catheterization
- Urinary tract infection patients
- Patients taking 5 alpha reductase inhibitor
- Known hypersensitivity to alfuzosin
- History of postural hypotension or syncope
- Hypertension patients treated with other alpha1-blockers
- Patients newly taking anticholinergic medication within 1 month
- Hepatic insufficiency (Aspartate transaminase /alanine aminotransferase ≥ 2 times of normal range)
- Renal insufficiency (s-Cr ≥ 2mg/dL)
- Unstable angina pectoris
- Uninvestigated hematuria
- Serum Prostate specific antigen ≥ 4 ng/mL (biopsy proven no cancer patients can be included)
- Interstitial cystitis patients
- Severe concomitant condition threatening life.
- Patient who is unable to make voiding diary
- Bladder or prostate cancer patients
- Patients receiving prostate or bladder surgery
Data sourced from ClinicalTrials.gov (NCT00696761). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.