The Long Term Effects of Alfuzosin(Xatral XL) in LUTS/BPH Patients: Evaluation of Voiding and Storage Function According to Bladder Outlet Obstruction Grade and Bladder Contractility
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 232
- 主要终点
- Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment
研究概览
简要总结
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.
详细描述
- Primary objective To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 12 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility
- Secondary objectives To evaluate efficacy on voiding and storage symptoms in LUTS/BPH patients after 3 months and 6 months of treatment with Xatral XL® by the grade of bladder outlet obstruction and/or bladder contractility To evaluate efficacy on maximal flow rate (MFR) and post-voided residual urine (PVR) To evaluate on voiding frequency, urgency severity & frequency, and nocturia To evaluate patient tolerability to the medication To evaluate global impression of improvement (GII)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
group1
Bladder outlet obstruction index(BOOI)≥ 20, Bladder contractility index(BCI)≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
干预措施: Alfuzosin (Drug)
group2
BOOI≥ 20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.
干预措施: Alfuzosin (Drug)
group 3
BOOI<20, BCI≥ 100 Alfuzosin was administered daily (10 mg) for 12 month.
干预措施: Alfuzosin (Drug)
group 4
BOOI<20, BCI<100 Alfuzosin was administered daily (10 mg) for 12 month.
干预措施: Alfuzosin (Drug)
结局指标
主要结局
Primary Outcome; International Prostate Symptom Score Changes Between 4 Groups Compared to Baseline After 12 mo Treatment
时间窗: 12months
international prostate symptom score was measured at baseline and 12 months. total scores on a scale range (from 0 to 35) higher values represent a worse outcome Baseline score minus 12-month score
Treatment Efficacy Was Analyzed by Validated Symptom Scores.
时间窗: 12 month
Alfuzosin was administered daily (10 mg). After 12 months of treatment, efficacy and safety were analyzed. Efficacy was measured by validated symptom scores (using IPSS ). IPSS score change was measured pre- and post- treatment.
次要结局
- Changes of International Continence Society (ICS)-Male Questionnaire (Voiding Sum)(12months)
- Changes of Peak Flow Rates on Uroflowmetry(12 months)
- Changes in Residual Urine Volumes(12 months)
研究者
Myung-Soo Choo
urology department
Asan Medical Center