Uroflowmetry Parameter (Delta Q Value) as a Noninvasive Tool to Discriminate Detrusor Underactivity From Bladder Outlet Obstruction
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 238
- 试验地点
- 2
- 主要终点
- Q average
研究概览
简要总结
To determine the significance of delta Q value (Qmax - Qave) in discrimination between BOO and DU, to avoid invasive studies (pressure flow studies (PFSs)) and replace them with noninvasive study (uroflowmetry).
详细描述
lower urinary tract symptoms (LUTS) in old male patients are usually secondary to prostatic hyperplasia. However, it is becoming clear nowadays that prostatic enlargement is not always the cause of male LUTS, and other factors could cause male LUTS in the presence of benign prostate enlargement (BPE).
Two clinical situations are common in elderly patients like Bladder Outlet Obstruction (BOO) and Detrusor underactivity (DU) they affect the voiding phase in elderly men markedly.
To distinguish one from another may be challenging and could be only done by urodynamic study (UDS), which is the gold standard for diagnosis.
A urodynamic study is an invasive procedure, with side effects of pain and urinary tract infection, and the need for special equipment and expertise has limited its widespread use and made it very stressful for the patients.
On the other hand, Uroflowmetry is a non-invasive procedure that could be used in patients' assessments. A term of Delta Q is being used that focuses on the difference between (Qmax) and (Q-average). The hypothesis is that Delta Q would be lower in Detrusor underactivity because of the undermined detrusor function decreasing both average and maximum urine flow rate, but it is higher in BOO, which has normal detrusor contraction during the voiding phase.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 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
- •male patients aged over 50 years complaining of voiding symptoms
- •International Prostatic Symptom Score (IPSS) 8 points or more,
- •serum prostate-specific antigen (PSA) below 4 ng/ml
- •no hematuria or pyuria.
排除标准
- •Patients who were unable to complete the voiding study were deemed not eligible to participate in this review.
- •patients with neurological causes of voiding dysfunction
- •history of urinary tract abnormalities/lithiasis, lower urinary tract surgeries, urinary tract malignancy.
- •acute UTI were excluded.
结局指标
主要结局
Q average
时间窗: preoperative test, it is done only once and comparative evaluation with other parameters will be done
Q average it represents the difference between Qmax and Q average in ml/sec as shown in uroflowmetry
次要结局
- post voiding residual urine(preoperative test, it is done only once and comparative evaluation with other parameters will be done)
- Q max(preoperative test, it is done only once and comparative evaluation with other parameters will be done)
- Q Average(preoperative test, it is done only once and comparative evaluation with other parameters will be done)
研究者
Ahmed Maher Gamil Ahmed Higazy
principle investigator
Ain Shams University