The Long Term Effects of Alfuzosin (Xatral XL) in LUTS/BPH Patients: Evaluation of Symptom-specific Goal Achievement According to Symptom Improvement, Bladder Outlet Obstruction Grade and Bladder Contractility
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 130
- 试验地点
- 2
- 主要终点
- Patient-reported goal achievements for the most bothersome symptoms
研究概览
简要总结
Lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH) consists of a constellation of symptoms (including voiding, storage, and post-micturition). The impact of the LUTS on patients' health-related quality of life is substantial and multifaceted. Thus, the therapies aimed at treating BPH are concerned primarily with improving patients' symptoms, thereby improving quality of life. When multiple symptoms are present, the level of bother associated with individual symptoms varies and patients prioritize their treatment goals for symptom relief. A measure that addresses patients' most bothersome symptoms (MBS) and evaluation of symptom-specific goal achievements may lead to improved outcomes and patient satisfaction to the treatment. The objectives of this study were (1) to assess patient-reported MBS and symptom-specific goal achievements (PGA) with medical treatment in BPH patients, and (2) to identify factors that influence or have relation to the PGA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •males ≥50 years with LUTS secondary to BPH
- •Moderate to severe LUTS : IPSS ≥ 8
- •An enlarged prostate : TRUS ≥25 mL
- •Decreased peak flow rate : Qmax ≤15mL/s (volume voided ≥ 120 mL)
- •Having signed the informed consent to participate in the study.
排除标准
- •Post voided residual urine ≥ 200mL
- •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 (AST/ALT ≥ 2 times of normal range)
- •Renal insufficiency (s-Cr ≥ 2mg/dL)
- •Unstable angina pectoris
- •Uninvestigated hematuria
- •Serum PSA ≥ 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
Alpha blocker
Alfuzosin 10mg
干预措施: Alfuzosin (Drug)
结局指标
主要结局
Patient-reported goal achievements for the most bothersome symptoms
时间窗: 12 months of treatment
次要结局
- Patient-reported goal achievement for the most bothersome symptom using Likert scale(3, 6, and 12 months of treatment)
- Global impression of improvement(3, 6, and 12 months of treatment)
- Changes in: IPSS, ICS-male questionnaire, maximal flow rate, post-voided residual urine, voiding chart parameters(3, 6, and 12 months of treatment)
研究者
KYU-SUNG LEE
professor
Samsung Medical Center