A 6-months Prospective, Observational Study to Evaluate the Quality of Life of Patients Treated With Phytotherapy or Alpha-blockersfor Benign Prostatic Hyperplasia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 288
- 试验地点
- 31
- 主要终点
- Benign Prostatic Hypertrophy Health-Related Quality of Life Questionnaire (BPHQOL9) M6
研究概览
简要总结
This is a prospective, multicentre, non-interventional study, conducted in France and Spain, in primary care practices and designed to assess the QoL of patients under phytotherapy or alpha-blockers for LUTS/BPH. The study will not provide or recommend any treatment or procedure.
详细描述
Any patient with moderate to severe LUTS/BPH initiating treatment with PT or AB during the inclusion period will be invited to participate in the study. Per usual practice, the physician will prescribe a treatment independently of the study. Patients will be consecutively enrolled in each of the 2 groups (PT or AB), regardless of the number of patients already enrolled in the other group. An average of 6 patients per General Practitioner (GP) is expected, i.e. 3 patients in each group. A GP who has reached 3 patients in a group will continue to recruit in the second group until reaching 2 groups of 3 patients. Once the two groups of 3 patients have been completed, the inclusions may be re-opened following the same procedure.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male patient
- •Age ≥ 40 years at the time of enrolment
- •Diagnosed with moderate to severe LUTS/BPH (IPSS ≥ 12)
- •Initiating a first-line PT or AB treatment for LUTS/BPH in monotherapy
- •Provided informed consent or non-opposition to study inclusion, and for the use of data, according to local regulations
排除标准
- •Underwent prostate surgery or urinary tract surgery
- •Diagnosed with one or several other diseases involving urinary function or prostate Diagnosed with BPH with complications (recurrent urinary tract infection, recurrent acute urinary retention, bladder calculus, bladder diverticulum, hydronephrosis, overflow incontinence, recurrent hematuria, obstructive renal failure) Participating in interventional trial on any investigational drug at time of inclusion Under treatment of the urinary functions
研究组 & 干预措施
Phytotherapy
Patients initiating a first-line phytotherapy treatment for LUTS/BPH in monotherapy
干预措施: Phytotherapy (Drug)
结局指标
主要结局
Benign Prostatic Hypertrophy Health-Related Quality of Life Questionnaire (BPHQOL9) M6
时间窗: 6 months
Mean difference in BPHQOL9 scores between baseline and M6, by group of treatment (PT and AB). For BPHQOL9, the total score can range from 0 to 90 (sum of all 9 items). A higher score means a better quality of life.
次要结局
- Benign Prostatic Hypertrophy Health-Related Quality of Life Questionnaire (BPHQOL9), M6(6 months)
- Quality of life Benign Prostatic Hypertrophy Health-Related Quality of Life Questionnaire (BPHQOL9)(6 months)
- Urinary symptoms profiles(6 months)
- Sexual Fonction(6 months)
- Safety (Adverse events)(6 months)