The Current Status and Progression of Symptoms and Comorbidities Among Male Lower Urinary Tract Symptoms Patients in China: a Multicenter Study From Prostatic Obstruction Investigation Team (POInT)
试验速览
- 阶段
- 不适用
- 入组人数
- 11,500
- 试验地点
- 1
- 主要终点
- The changes of IPSS scores between baseline and follow-up
研究概览
简要总结
The present is a multicenter, observational study organized by the Prostatic Obstruction Investigation Team (POInT), with a main purpose of looking into the current status and symptom progression of male lower urinary tract symptoms patients in China.
详细描述
Lower urinary tract symptoms (LUTS) is a common medical condition negatively affecting people's quality of life worldwide. LUTS may be caused by structural or functional abnormalities in 1 or more parts of the lower urinary tract, including bladder, prostate, internal and external urethral sphincter and distal urethra. Furthermore, evidence exists to demonstrate that LUTS is associate with lifestyle factors, systemic comorbidities and geriatric diseases, such as smoking, obesity, metabolic syndrome, chronic kidney diseases and chronic obstructive pulmonary disease etc. So far, there is lack of evidence to illustrate the symptom features and comorbidities among Chinese male LUTS patients. Therefore, this multicenter clinical study aims to investigate the present status and symptom progression among male LUTS patients in China.
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
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male, 45 years or older.
- •The presence of lower urinary tract symptoms, i.e. frequency, urgency, urge incontinence, dysuria, post-micturition dribble, etc.
- •All participants have signed the informed consent form.
- •Clinical data comes from 23 selected hospitals spread across China.
排除标准
- •Lower urinary tract symptoms as a result of urethral stricture, stone diseases, chronic prostatitis, space-occupying lesions etc.
- •Diagnosis or suspicion of renal, ureteral, bladder, prostate, urethral or pelvic tumor.
- •Known neurogenic or congenital lower urinary tract dysfunction.
- •Known urinary tract, prostate or pelvic surgical history.
- •Existence of anatomical abnormalities of the urinary tract (e.g. diverticulum of the bladder or urethra, ectopic ureteral orifice etc.).
- •The presence of acute conditions, such as, urinary tract infection, fever, heart failure etc.
- •Patients with poor compliance or cognitive competence.
研究组 & 干预措施
Oral medication group
Patients in this group will receive oral medications to treat lower urinary tract symptoms
干预措施: Oral medications to treat lower urinary tract symptoms (Drug)
Surgical treatment group
Patients in this group receive minimal invasive transurethral prostate procedures.
干预措施: Minimal invasive transurethral prostate procedures (Procedure)
结局指标
主要结局
The changes of IPSS scores between baseline and follow-up
时间窗: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery.
Measured using standard IPSS scoring system
The changes of nocturia symptoms between baseline and follow-up
时间窗: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery
Measured using standard ICIQ-N-QoL score
The changes of erectile function between baseline and follow-up
时间窗: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided, or 1, 6, 18, 24 months after surgery
Measured using standard IIEF score
The changes of maximum flow rate (ml/s) between baseline and follow-up
时间窗: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery
Maximum flow rate will be measured using urinary flow study
The changes of post void residual volume (ml) between baseline and follow-up
时间窗: Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery
post void residual volume (ml) will be measured using urinary flow study
The changes of detrusor pressure at maximum flow rate (cmH2O) between baseline and follow-up
时间窗: Measured at baseline (if surgical treatment is required) and 1, 6, 18, 24 months after surgery
It will be measured using pressure-flow study
The changes of intravesical prostate protrusion (mm) between baseline and follow-up
时间窗: Measured at baseline and 6, 12, 18, 24, 36 months after oral medication treatment
Intravesical prostate protrusion (mm) will be measured using transrectal prostate ultrasound and calculated as the distance between the tip of the prostate median lobe and bladder neck
The changes of prostate volume (ml) between baseline and follow-up
时间窗: Measured at baseline and 6, 12, 18, 24, 36 months after oral medication treatment
Prostate volume (ml) will be measured using transrectal prostate ultrasound and calculated as: prostate volume (ml) = length (mm) \* width (mm) \* height (mm) \* 0.52
次要结局
- The changes of Kidney function between baseline and follow-up(Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.)
- The changes of WBC (/HP) between baseline and follow-up(Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.)
- The changes of Blood pressure between baseline and follow-up(Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.)
- The changes of Blood lipid between baseline and follow-up(Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.)
- The changes of Blood glucose between baseline and follow-up(Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.)
- The changes of PSA (ng/ml) between baseline and follow-up(Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.)
- The changes of RBC (/HP) between baseline and follow-up(Measured at baseline and 6, 12, 18, 24, 36 months if oral medication is provided or 1, 6, 18, 24 months after surgery.)